Trial Outcomes & Findings for Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years (NCT NCT00771615)
NCT ID: NCT00771615
Last Updated: 2018-09-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
469 participants
Primary outcome timeframe
At Day 10
Results posted on
2018-09-21
Participant Flow
Participant milestones
| Measure |
A/Turkey H5N1 Influenza Formulation A Group
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.
|
A/Turkey H5N1 Influenza Formulation B1 Group
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.
|
A/Turkey H5N1 Influenza Formulation B2 Group
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.
|
A/Turkey H5N1 Influenza Formulation C1 Group
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.
|
A/Turkey H5N1 Influenza Formulation C2 Group
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.
|
A/Turkey H5N1 Influenza Formulation D1 Group
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.
|
A/Turkey H5N1 Influenza Formulation D2 Group
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.
|
A/Turkey H5N1 Influenza Formulation E1 Group
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.
|
A/Turkey H5N1 Influenza Formulation E2 Group
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 Study
STARTED
|
49
|
72
|
41
|
60
|
40
|
61
|
46
|
59
|
41
|
|
Overall Study
COMPLETED
|
48
|
70
|
40
|
59
|
40
|
60
|
45
|
58
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
1
|
0
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
A/Turkey H5N1 Influenza Formulation A Group
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.
|
A/Turkey H5N1 Influenza Formulation B1 Group
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.
|
A/Turkey H5N1 Influenza Formulation B2 Group
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.
|
A/Turkey H5N1 Influenza Formulation C1 Group
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.
|
A/Turkey H5N1 Influenza Formulation C2 Group
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.
|
A/Turkey H5N1 Influenza Formulation D1 Group
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.
|
A/Turkey H5N1 Influenza Formulation D2 Group
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.
|
A/Turkey H5N1 Influenza Formulation E1 Group
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.
|
A/Turkey H5N1 Influenza Formulation E2 Group
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 Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years
Baseline characteristics by cohort
| Measure |
A/Turkey H5N1 Influenza Formulation A Group
n=49 Participants
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.
|
A/Turkey H5N1 Influenza Formulation B1 Group
n=72 Participants
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.
|
A/Turkey H5N1 Influenza Formulation B2 Group
n=41 Participants
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.
|
A/Turkey H5N1 Influenza Formulation C1 Group
n=60 Participants
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.
|
A/Turkey H5N1 Influenza Formulation C2 Group
n=40 Participants
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.
|
A/Turkey H5N1 Influenza Formulation D1 Group
n=61 Participants
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.
|
A/Turkey H5N1 Influenza Formulation D2 Group
n=46 Participants
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.
|
A/Turkey H5N1 Influenza Formulation E1 Group
n=59 Participants
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.
|
A/Turkey H5N1 Influenza Formulation E2 Group
n=41 Participants
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
n=469 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
40.6 Years
STANDARD_DEVIATION 12.02 • n=7 Participants
|
41.1 Years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
41.2 Years
STANDARD_DEVIATION 12.33 • n=4 Participants
|
41.1 Years
STANDARD_DEVIATION 12.46 • n=21 Participants
|
42.4 Years
STANDARD_DEVIATION 11.15 • n=8 Participants
|
41.2 Years
STANDARD_DEVIATION 9.78 • n=8 Participants
|
40.6 Years
STANDARD_DEVIATION 12.01 • n=24 Participants
|
41.6 Years
STANDARD_DEVIATION 11.60 • n=42 Participants
|
41.3 Years
STANDARD_DEVIATION 11.55 • n=42 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
37 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
277 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
192 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: At Day 10Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=126 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=84 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=127 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=85 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
|
43 Participants
|
121 Participants
|
109 Participants
|
57 Participants
|
56 Participants
|
122 Participants
|
108 Participants
|
51 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: At Day 10Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=126 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=84 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=127 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=85 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
|
44 Participants
|
125 Participants
|
113 Participants
|
76 Participants
|
67 Participants
|
127 Participants
|
111 Participants
|
69 Participants
|
74 Participants
|
PRIMARY outcome
Timeframe: At Day 10Population: 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.
HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=126 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=84 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=127 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=85 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
|
229.6 Titer
Interval 148.6 to 354.9
|
847.3 Titer
Interval 686.1 to 1046.4
|
810.5 Titer
Interval 666.6 to 985.3
|
121.9 Titer
Interval 89.7 to 165.7
|
86.9 Titer
Interval 64.7 to 116.7
|
838.5 Titer
Interval 703.1 to 1000.1
|
819.8 Titer
Interval 647.8 to 1037.3
|
97.9 Titer
Interval 70.3 to 136.4
|
108.6 Titer
Interval 82.3 to 143.3
|
SECONDARY outcome
Timeframe: At Day 0 to Day 42 and at Day 0 to Day 182Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A/turkey, D 42
|
41 Participants
|
123 Participants
|
108 Participants
|
55 Participants
|
51 Participants
|
123 Participants
|
108 Participants
|
45 Participants
|
61 Participants
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A/turkey, D 182
|
28 Participants
|
105 Participants
|
90 Participants
|
38 Participants
|
38 Participants
|
103 Participants
|
92 Participants
|
31 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 10, Day 42 and Day 182Population: 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.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
A/turkey, D 0
|
6.1 Titer
Interval 5.0 to 7.5
|
13.5 Titer
Interval 11.3 to 16.3
|
14.4 Titer
Interval 11.6 to 18.0
|
14.2 Titer
Interval 11.3 to 17.9
|
10.9 Titer
Interval 8.7 to 13.6
|
14.1 Titer
Interval 11.6 to 17.2
|
13.7 Titer
Interval 11.1 to 16.9
|
13.2 Titer
Interval 10.3 to 17.1
|
11.8 Titer
Interval 9.6 to 14.5
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
A/turkey, D 10
|
229.6 Titer
Interval 148.6 to 354.9
|
847.3 Titer
Interval 686.1 to 1046.4
|
810.5 Titer
Interval 666.6 to 985.3
|
121.9 Titer
Interval 89.7 to 165.7
|
86.9 Titer
Interval 64.7 to 116.7
|
838.5 Titer
Interval 703.1 to 1000.1
|
819.8 Titer
Interval 647.8 to 1037.3
|
97.9 Titer
Interval 70.3 to 136.4
|
108.6 Titer
Interval 82.3 to 143.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
A/turkey, D 42
|
155.4 Titer
Interval 102.1 to 236.3
|
652.2 Titer
Interval 525.3 to 809.8
|
699.5 Titer
Interval 561.9 to 870.8
|
126.3 Titer
Interval 91.6 to 174.1
|
81.4 Titer
Interval 59.6 to 111.2
|
653.9 Titer
Interval 545.5 to 783.9
|
697.8 Titer
Interval 539.2 to 903.2
|
90.9 Titer
Interval 64.7 to 127.6
|
113.6 Titer
Interval 84.1 to 153.4
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
A/turkey, D 182
|
40.9 Titer
Interval 26.8 to 62.4
|
221.5 Titer
Interval 172.3 to 284.6
|
238.4 Titer
Interval 185.1 to 307.0
|
62.7 Titer
Interval 44.9 to 87.5
|
42.9 Titer
Interval 31.6 to 58.3
|
213.3 Titer
Interval 170.5 to 266.9
|
249.1 Titer
Interval 187.6 to 330.8
|
51.1 Titer
Interval 37.2 to 70.3
|
53.2 Titer
Interval 38.3 to 73.8
|
SECONDARY outcome
Timeframe: At Day 0 to Day 10, Day 42 and Day 182Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A/turkey, D 10
|
37.4 fold change
Interval 23.3 to 59.9
|
61.6 fold change
Interval 47.4 to 80.1
|
56.3 fold change
Interval 43.5 to 72.8
|
8.5 fold change
Interval 6.0 to 12.1
|
8.0 fold change
Interval 6.0 to 10.7
|
58.4 fold change
Interval 45.5 to 74.9
|
59.8 fold change
Interval 45.5 to 78.6
|
7.4 fold change
Interval 5.2 to 10.5
|
9.1 fold change
Interval 6.8 to 12.3
|
|
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A/turkey, D 42
|
25.3 fold change
Interval 16.6 to 38.5
|
48.2 fold change
Interval 37.2 to 62.5
|
48.6 fold change
Interval 37.5 to 63.0
|
8.9 fold change
Interval 6.2 to 12.9
|
7.5 fold change
Interval 5.6 to 10.1
|
46.3 fold change
Interval 36.2 to 59.2
|
50.9 fold change
Interval 38.6 to 67.1
|
6.9 fold change
Interval 4.8 to 9.8
|
9.6 fold change
Interval 7.1 to 13.1
|
|
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A/turkey, D 182
|
6.7 fold change
Interval 4.4 to 10.0
|
16.4 fold change
Interval 12.4 to 21.5
|
16.6 fold change
Interval 12.7 to 21.6
|
4.4 fold change
Interval 3.0 to 6.3
|
3.9 fold change
Interval 2.9 to 5.2
|
15.1 fold change
Interval 11.6 to 19.6
|
18.2 fold change
Interval 13.7 to 24.1
|
3.9 fold change
Interval 2.7 to 5.4
|
4.4 fold change
Interval 3.2 to 6.1
|
SECONDARY outcome
Timeframe: At Day 0, Day 10, Day 42 and Day 182Population: 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.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
A/Indo, D182
|
34.8 Titer
Interval 22.6 to 53.6
|
213.8 Titer
Interval 166.4 to 274.6
|
224.2 Titer
Interval 174.4 to 288.3
|
58.7 Titer
Interval 41.2 to 83.6
|
38.6 Titer
Interval 28.0 to 53.3
|
197.3 Titer
Interval 156.0 to 249.5
|
246.0 Titer
Interval 188.0 to 321.9
|
42.7 Titer
Interval 30.4 to 60.0
|
53.4 Titer
Interval 37.9 to 75.2
|
|
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
A/Indo, D 0
|
7.3 Titer
Interval 5.6 to 9.4
|
26.1 Titer
Interval 20.8 to 32.7
|
23.8 Titer
Interval 18.6 to 30.5
|
25.5 Titer
Interval 19.3 to 33.7
|
18.5 Titer
Interval 13.9 to 24.5
|
25.5 Titer
Interval 20.2 to 32.1
|
24.5 Titer
Interval 19.2 to 31.1
|
22.0 Titer
Interval 16.6 to 29.1
|
21.7 Titer
Interval 16.3 to 28.8
|
|
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
A/Indo, D 10
|
286.5 Titer
Interval 187.6 to 437.5
|
905.0 Titer
Interval 743.7 to 1101.4
|
888.6 Titer
Interval 739.6 to 1067.5
|
176.7 Titer
Interval 131.9 to 236.8
|
113.6 Titer
Interval 83.2 to 155.1
|
873.5 Titer
Interval 738.5 to 1033.3
|
924.9 Titer
Interval 745.0 to 1148.1
|
124.6 Titer
Interval 89.4 to 173.8
|
161.3 Titer
Interval 122.3 to 212.8
|
|
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
A/Indo, D 42
|
192.3 Titer
Interval 129.3 to 286.1
|
740.8 Titer
Interval 604.7 to 907.4
|
798.1 Titer
Interval 656.6 to 970.1
|
168.7 Titer
Interval 123.5 to 230.5
|
108.8 Titer
Interval 77.7 to 152.4
|
728.1 Titer
Interval 613.5 to 864.1
|
814.6 Titer
Interval 646.3 to 1026.8
|
107.8 Titer
Interval 75.6 to 153.8
|
169.3 Titer
Interval 126.1 to 227.2
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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.
A/Indo, D 0
|
5 Participants
|
70 Participants
|
56 Participants
|
44 Participants
|
31 Participants
|
68 Participants
|
58 Participants
|
34 Participants
|
41 Participants
|
|
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.
A/Indo, D 10
|
44 Participants
|
125 Participants
|
113 Participants
|
79 Participants
|
68 Participants
|
127 Participants
|
111 Participants
|
69 Participants
|
78 Participants
|
|
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.
A/Indo, D 42
|
44 Participants
|
126 Participants
|
113 Participants
|
78 Participants
|
67 Participants
|
129 Participants
|
110 Participants
|
66 Participants
|
79 Participants
|
|
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.
A/Indo, D 182
|
28 Participants
|
116 Participants
|
106 Participants
|
58 Participants
|
47 Participants
|
121 Participants
|
101 Participants
|
48 Participants
|
57 Participants
|
|
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.
A/turkey, D 0
|
3 Participants
|
32 Participants
|
35 Participants
|
25 Participants
|
16 Participants
|
36 Participants
|
31 Participants
|
23 Participants
|
18 Participants
|
|
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.
A/turkey, D 42
|
41 Participants
|
126 Participants
|
113 Participants
|
74 Participants
|
62 Participants
|
129 Participants
|
110 Participants
|
64 Participants
|
72 Participants
|
|
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.
A/turkey, D 182
|
31 Participants
|
119 Participants
|
106 Participants
|
58 Participants
|
53 Participants
|
122 Participants
|
103 Participants
|
54 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: At Day 0 to Day 10, Day 42 and Day 182Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A/Indo, D 10
|
42 Participants
|
122 Participants
|
108 Participants
|
50 Participants
|
44 Participants
|
122 Participants
|
108 Participants
|
41 Participants
|
53 Participants
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A/Indo, D 42
|
42 Participants
|
120 Participants
|
105 Participants
|
48 Participants
|
43 Participants
|
121 Participants
|
104 Participants
|
38 Participants
|
53 Participants
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A/Indo, D 182
|
25 Participants
|
91 Participants
|
84 Participants
|
24 Participants
|
22 Participants
|
96 Participants
|
79 Participants
|
20 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: At Day 10, Day 42 and Day 182Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A/Indo, D 10
|
39.3 fold change
Interval 24.8 to 62.4
|
34.7 fold change
Interval 26.8 to 44.8
|
37.3 fold change
Interval 28.5 to 48.8
|
6.8 fold change
Interval 4.9 to 9.5
|
6.1 fold change
Interval 4.5 to 8.3
|
34.3 fold change
Interval 26.8 to 43.8
|
37.8 fold change
Interval 28.5 to 50.2
|
5.7 fold change
Interval 4.1 to 7.9
|
7.3 fold change
Interval 5.4 to 10.0
|
|
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A/Indo, D 42
|
26.4 fold change
Interval 17.2 to 40.5
|
28.4 fold change
Interval 22.0 to 36.7
|
33.5 fold change
Interval 25.4 to 44.3
|
6.6 fold change
Interval 4.7 to 9.4
|
5.9 fold change
Interval 4.3 to 8.1
|
28.6 fold change
Interval 22.3 to 36.6
|
33.3 fold change
Interval 24.9 to 44.5
|
4.9 fold change
Interval 3.4 to 7.0
|
7.8 fold change
Interval 5.7 to 10.7
|
|
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A/Indo, D 182
|
4.8 fold change
Interval 3.1 to 7.4
|
8.2 fold change
Interval 6.3 to 10.7
|
9.4 fold change
Interval 7.2 to 12.3
|
2.3 fold change
Interval 1.6 to 3.3
|
2.1 fold change
Interval 1.6 to 2.8
|
7.7 fold change
Interval 6.0 to 9.9
|
10.1 fold change
Interval 7.6 to 13.4
|
1.9 fold change
Interval 1.4 to 2.7
|
2.5 fold change
Interval 1.8 to 3.4
|
SECONDARY outcome
Timeframe: At Day 0, Day 10, Day 42 and Day 182Population: 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.
MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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.
A/turkey, D 0
|
27.5 Titer
Interval 20.6 to 36.7
|
115.4 Titer
Interval 92.7 to 143.7
|
114.6 Titer
Interval 91.0 to 144.4
|
102.9 Titer
Interval 82.4 to 128.4
|
94.9 Titer
Interval 71.0 to 126.9
|
115.0 Titer
Interval 92.4 to 143.2
|
115.1 Titer
Interval 91.3 to 145.0
|
95.9 Titer
Interval 73.8 to 124.6
|
101.9 Titer
Interval 79.2 to 130.9
|
|
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.
A/turkey, D 10
|
2211.5 Titer
Interval 1579.1 to 3097.1
|
5367.7 Titer
Interval 4604.3 to 6257.6
|
5191.4 Titer
Interval 4403.4 to 6120.5
|
1276.2 Titer
Interval 962.5 to 1692.1
|
976.0 Titer
Interval 740.6 to 1286.1
|
5670.5 Titer
Interval 4958.4 to 6484.8
|
4876.8 Titer
Interval 4057.3 to 5861.7
|
1026.9 Titer
Interval 756.6 to 1393.9
|
1213.4 Titer
Interval 939.3 to 1567.5
|
|
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.
A/turkey, D 42
|
1582.9 Titer
Interval 1080.4 to 2319.0
|
4777.7 Titer
Interval 4037.3 to 5654.0
|
4649.4 Titer
Interval 3884.9 to 5564.3
|
1261.2 Titer
Interval 950.0 to 1674.2
|
906.0 Titer
Interval 673.6 to 1218.6
|
4915.6 Titer
Interval 4212.6 to 5735.8
|
4498.4 Titer
Interval 3699.9 to 5469.2
|
935.7 Titer
Interval 688.9 to 1271.0
|
1223.9 Titer
Interval 929.0 to 1612.3
|
|
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.
A/turkey, D 182
|
349.7 Titer
Interval 246.2 to 496.7
|
1509.9 Titer
Interval 1230.5 to 1852.8
|
1484.8 Titer
Interval 1181.6 to 1865.8
|
471.5 Titer
Interval 352.2 to 631.3
|
342.2 Titer
Interval 254.8 to 459.7
|
1375.0 Titer
Interval 1123.6 to 1682.7
|
1653.6 Titer
Interval 1313.4 to 2081.9
|
332.3 Titer
Interval 245.2 to 450.3
|
484.8 Titer
Interval 365.7 to 642.8
|
|
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.
A/Indo, D 0
|
72.8 Titer
Interval 52.0 to 101.9
|
326.0 Titer
Interval 280.2 to 379.3
|
300.2 Titer
Interval 256.7 to 351.1
|
343.4 Titer
Interval 288.8 to 408.2
|
262.0 Titer
Interval 220.9 to 310.9
|
308.1 Titer
Interval 263.0 to 361.0
|
320.1 Titer
Interval 276.3 to 371.0
|
288.1 Titer
Interval 238.3 to 348.3
|
313.7 Titer
Interval 267.3 to 368.2
|
|
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.
A/Indo, D 10
|
2311.5 Titer
Interval 1708.9 to 3126.5
|
5807.1 Titer
Interval 5144.8 to 6554.7
|
5680.0 Titer
Interval 4943.7 to 6525.9
|
1516.5 Titer
Interval 1194.5 to 1925.3
|
1250.0 Titer
Interval 1002.6 to 1558.5
|
6011.0 Titer
Interval 5424.1 to 6661.5
|
5460.9 Titer
Interval 4670.2 to 6385.4
|
1240.9 Titer
Interval 966.2 to 1593.7
|
1523.4 Titer
Interval 1233.4 to 1881.5
|
|
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.
A/Indo, D 42
|
1622.0 Titer
Interval 1105.2 to 2380.4
|
5080.1 Titer
Interval 4412.0 to 5849.3
|
5054.1 Titer
Interval 4276.6 to 5972.8
|
1537.2 Titer
Interval 1192.0 to 1982.3
|
1194.5 Titer
Interval 940.0 to 1517.9
|
5157.1 Titer
Interval 4518.4 to 5886.0
|
4967.0 Titer
Interval 4163.2 to 5926.0
|
1178.0 Titer
Interval 916.6 to 1514.0
|
1552.4 Titer
Interval 1216.5 to 1981.0
|
|
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.
A/Indo, D 182
|
380.8 Titer
Interval 267.5 to 542.1
|
1482.3 Titer
Interval 1223.3 to 1796.1
|
1556.0 Titer
Interval 1265.4 to 1913.3
|
535.5 Titer
Interval 416.8 to 688.0
|
378.4 Titer
Interval 288.7 to 496.1
|
1358.2 Titer
Interval 1130.0 to 1632.5
|
1721.5 Titer
Interval 1390.0 to 2132.1
|
379.4 Titer
Interval 287.9 to 500.0
|
534.2 Titer
Interval 417.9 to 682.8
|
|
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.
A/Vie, D 0
|
181.3 Titer
Interval 138.5 to 237.4
|
210.1 Titer
Interval 177.0 to 249.4
|
249.0 Titer
Interval 217.8 to 284.7
|
197.3 Titer
Interval 159.0 to 244.9
|
205.5 Titer
Interval 161.8 to 261.1
|
237.5 Titer
Interval 206.4 to 273.2
|
216.5 Titer
Interval 181.6 to 258.2
|
198.7 Titer
Interval 155.2 to 254.3
|
203.7 Titer
Interval 165.2 to 251.0
|
|
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.
A/Vie, D 10
|
662.5 Titer
Interval 526.4 to 833.9
|
1564.1 Titer
Interval 1312.0 to 1864.7
|
1350.1 Titer
Interval 1142.2 to 1595.8
|
552.0 Titer
Interval 447.8 to 680.4
|
430.5 Titer
Interval 351.8 to 527.0
|
1485.0 Titer
Interval 1250.8 to 1763.1
|
1430.0 Titer
Interval 1202.3 to 1700.8
|
509.3 Titer
Interval 408.1 to 635.6
|
470.8 Titer
Interval 387.7 to 571.8
|
|
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.
A/Vie, D 42
|
529.3 Titer
Interval 426.2 to 657.2
|
1213.8 Titer
Interval 1004.5 to 1466.6
|
1249.3 Titer
Interval 1033.4 to 1510.3
|
589.4 Titer
Interval 469.5 to 739.9
|
377.8 Titer
Interval 311.3 to 458.5
|
1168.1 Titer
Interval 969.8 to 1407.1
|
1306.0 Titer
Interval 1076.8 to 1584.1
|
481.8 Titer
Interval 382.4 to 607.0
|
469.0 Titer
Interval 381.8 to 576.2
|
|
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.
A/Vie, D 182
|
112.5 Titer
Interval 84.5 to 149.8
|
432.5 Titer
Interval 366.6 to 510.2
|
324.9 Titer
Interval 260.0 to 406.1
|
172.7 Titer
Interval 137.9 to 216.3
|
144.1 Titer
Interval 119.9 to 173.3
|
371.4 Titer
Interval 309.2 to 446.1
|
386.3 Titer
Interval 313.8 to 475.5
|
151.7 Titer
Interval 120.5 to 191.0
|
164.5 Titer
Interval 136.7 to 198.1
|
SECONDARY outcome
Timeframe: At Day 0, Day 10, Day 42 and Day 182Population: 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.
A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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.
A/Indo, D 42
|
46 Participants
|
128 Participants
|
113 Participants
|
85 Participants
|
80 Participants
|
129 Participants
|
112 Participants
|
79 Participants
|
86 Participants
|
|
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.
A/Indo, D 182
|
46 Participants
|
128 Participants
|
112 Participants
|
83 Participants
|
78 Participants
|
128 Participants
|
112 Participants
|
78 Participants
|
83 Participants
|
|
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.
A/Vie, D 0
|
46 Participants
|
120 Participants
|
112 Participants
|
80 Participants
|
76 Participants
|
126 Participants
|
106 Participants
|
73 Participants
|
83 Participants
|
|
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.
A/Vie, D10
|
47 Participants
|
126 Participants
|
113 Participants
|
84 Participants
|
80 Participants
|
127 Participants
|
112 Participants
|
79 Participants
|
85 Participants
|
|
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.
A/Vie, D 42
|
47 Participants
|
128 Participants
|
112 Participants
|
85 Participants
|
80 Participants
|
128 Participants
|
112 Participants
|
79 Participants
|
86 Participants
|
|
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.
A/Vie, D 182
|
44 Participants
|
126 Participants
|
106 Participants
|
80 Participants
|
77 Participants
|
124 Participants
|
108 Participants
|
74 Participants
|
83 Participants
|
|
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.
A/turkey, D 42
|
47 Participants
|
128 Participants
|
113 Participants
|
85 Participants
|
79 Participants
|
129 Participants
|
112 Participants
|
79 Participants
|
85 Participants
|
|
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.
A/turkey, D 182
|
46 Participants
|
128 Participants
|
111 Participants
|
82 Participants
|
77 Participants
|
127 Participants
|
112 Participants
|
75 Participants
|
84 Participants
|
|
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.
A/Indo, D 0
|
36 Participants
|
126 Participants
|
112 Participants
|
85 Participants
|
79 Participants
|
127 Participants
|
111 Participants
|
78 Participants
|
86 Participants
|
|
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.
A/Indo, D 10
|
47 Participants
|
126 Participants
|
113 Participants
|
84 Participants
|
80 Participants
|
127 Participants
|
112 Participants
|
79 Participants
|
85 Participants
|
|
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.
A/turkey, D 0
|
20 Participants
|
116 Participants
|
102 Participants
|
80 Participants
|
68 Participants
|
114 Participants
|
104 Participants
|
71 Participants
|
77 Participants
|
|
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.
A/turkey, D 10
|
47 Participants
|
126 Participants
|
113 Participants
|
84 Participants
|
80 Participants
|
127 Participants
|
112 Participants
|
79 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: At Day 10Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=126 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=84 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=127 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=85 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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.
A/turkey, Day 10
|
46 Participants
|
122 Participants
|
112 Participants
|
66 Participants
|
56 Participants
|
124 Participants
|
110 Participants
|
55 Participants
|
67 Participants
|
|
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.
A/Indo, Day 10
|
45 Participants
|
121 Participants
|
105 Participants
|
36 Participants
|
40 Participants
|
122 Participants
|
104 Participants
|
32 Participants
|
44 Participants
|
|
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.
A/Vie, Day 10
|
19 Participants
|
84 Participants
|
64 Participants
|
29 Participants
|
18 Participants
|
75 Participants
|
73 Participants
|
24 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At Day 42Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=85 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=80 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=86 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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
A/turkey, Day 42
|
46 Participants
|
121 Participants
|
110 Participants
|
67 Participants
|
58 Participants
|
122 Participants
|
109 Participants
|
56 Participants
|
69 Participants
|
|
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
A/Indo, D 42
|
41 Participants
|
118 Participants
|
103 Participants
|
39 Participants
|
38 Participants
|
119 Participants
|
102 Participants
|
31 Participants
|
46 Participants
|
|
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
A/Vie, D 42
|
15 Participants
|
73 Participants
|
65 Participants
|
32 Participants
|
15 Participants
|
71 Participants
|
67 Participants
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: At Day 182Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=47 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=128 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=113 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=84 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=129 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=112 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=79 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=84 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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.
A/turkey, Day 182
|
34 Participants
|
103 Participants
|
89 Participants
|
43 Participants
|
36 Participants
|
102 Participants
|
90 Participants
|
35 Participants
|
44 Participants
|
|
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.
A/Indo, Day 182
|
28 Participants
|
68 Participants
|
72 Participants
|
15 Participants
|
17 Participants
|
71 Participants
|
69 Participants
|
13 Participants
|
19 Participants
|
|
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.
A/Vie, Day 182
|
5 Participants
|
32 Participants
|
22 Participants
|
11 Participants
|
5 Participants
|
24 Participants
|
30 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Within the 7-day (Days 0-6) post vaccination period.Population: 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.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=49 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=72 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=40 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=60 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=40 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=60 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=46 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=58 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=41 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
41 Participants
|
59 Participants
|
9 Participants
|
53 Participants
|
10 Participants
|
48 Participants
|
13 Participants
|
46 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
1 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Swelling
|
6 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 7-day (Days 0-6) post vaccination period.Population: 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.
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).
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=49 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=72 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=40 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=60 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=40 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=60 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=46 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=58 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=41 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any Fatigue
|
10 Participants
|
18 Participants
|
3 Participants
|
20 Participants
|
6 Participants
|
18 Participants
|
4 Participants
|
23 Participants
|
11 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any Headache
|
11 Participants
|
22 Participants
|
4 Participants
|
25 Participants
|
5 Participants
|
17 Participants
|
8 Participants
|
17 Participants
|
10 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any Joint pain
|
5 Participants
|
16 Participants
|
1 Participants
|
10 Participants
|
4 Participants
|
12 Participants
|
2 Participants
|
19 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any Muscle aches
|
10 Participants
|
29 Participants
|
3 Participants
|
17 Participants
|
7 Participants
|
21 Participants
|
8 Participants
|
28 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any Shivering
|
3 Participants
|
9 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any Sweating
|
4 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 378Population: 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.
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).
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=49 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=72 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=41 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=60 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=40 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=61 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=46 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=59 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=41 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Medically-attended Adverse Events (MAEs).
|
17 Participants
|
24 Participants
|
13 Participants
|
18 Participants
|
13 Participants
|
21 Participants
|
16 Participants
|
20 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 42Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=49 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=72 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=41 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=60 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=40 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=61 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=46 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=59 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=41 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
|
9 Participants
|
27 Participants
|
12 Participants
|
26 Participants
|
11 Participants
|
21 Participants
|
12 Participants
|
23 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 378Population: 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.
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.
Outcome measures
| Measure |
A/Turkey H5N1 Influenza A Group
n=49 Participants
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.
|
A/Turkey H5N1 Influenza B1 + D1 Group
n=72 Participants
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.
|
A/Turkey H5N1 Influenza C1 + E1 Group
n=41 Participants
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.
|
A/Turkey H5N1 Influenza B2 + D2 Group
n=60 Participants
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.
|
A/Turkey H5N1 Influenza C2 + E2 Group
n=40 Participants
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.
|
A/Turkey H5N1 Influenza B1 + C1 Group
n=61 Participants
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.
|
A/Turkey H5N1 Influenza D1 + E1 Group
n=46 Participants
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.
|
A/Turkey H5N1 Influenza B2 + C2 Group
n=59 Participants
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.
|
A/Turkey H5N1 Influenza D2 + E2 Group
n=41 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs).
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
A/Turkey H5N1 Influenza Formulation D1 Group
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
A/Turkey H5N1 Influenza Formulation D2 Group
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
A/Turkey H5N1 Influenza Formulation E1 Group
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
A/Turkey H5N1 Influenza Formulation E2 Group
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
A/Turkey H5N1 Influenza Formulation A Group
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
A/Turkey H5N1 Influenza Formulation B1 Group
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
A/Turkey H5N1 Influenza Formulation B2 Group
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
A/Turkey H5N1 Influenza Formulation C1 Group
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
A/Turkey H5N1 Influenza Formulation C2 Group
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A/Turkey H5N1 Influenza Formulation D1 Group
n=61 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation D2 Group
n=46 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation E1 Group
n=59 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation E2 Group
n=41 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation A Group
n=49 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation B1 Group
n=72 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation B2 Group
n=41 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation C1 Group
n=60 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation C2 Group
n=40 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
5.0%
2/40 • 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.
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
1.7%
1/60 • 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.
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.
|
2.5%
1/40 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
2.0%
1/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
2.0%
1/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
1.7%
1/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/61 • 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.
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.
|
2.2%
1/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
2.4%
1/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
2.0%
1/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
1.6%
1/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
Other adverse events
| Measure |
A/Turkey H5N1 Influenza Formulation D1 Group
n=61 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation D2 Group
n=46 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation E1 Group
n=59 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation E2 Group
n=41 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation A Group
n=49 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation B1 Group
n=72 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation B2 Group
n=41 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation C1 Group
n=60 participants at risk
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.
|
A/Turkey H5N1 Influenza Formulation C2 Group
n=40 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
80.0%
48/60 • 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.
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.
|
28.3%
13/46 • 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.
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.
|
79.3%
46/58 • 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.
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.
|
14.6%
6/41 • 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.
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.
|
83.7%
41/49 • 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.
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.
|
81.9%
59/72 • 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.
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.
|
22.5%
9/40 • 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.
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.
|
88.3%
53/60 • 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.
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.
|
25.0%
10/40 • 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.
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.
|
|
General disorders
Redness
|
6.7%
4/60 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
1.7%
1/58 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
2.0%
1/49 • 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.
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.
|
4.2%
3/72 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
6.7%
4/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
General disorders
Swelling
|
8.3%
5/60 • 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.
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.
|
2.2%
1/46 • 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.
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.
|
3.4%
2/58 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
12.2%
6/49 • 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.
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.
|
2.8%
2/72 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
6.7%
4/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
General disorders
Fatigue
|
30.0%
18/60 • 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.
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.
|
8.7%
4/46 • 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.
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.
|
39.7%
23/58 • 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.
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.
|
26.8%
11/41 • 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.
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.
|
20.4%
10/49 • 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.
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.
|
25.0%
18/72 • 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.
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.
|
7.5%
3/40 • 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.
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.
|
33.3%
20/60 • 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.
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.
|
15.0%
6/40 • 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.
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.
|
|
General disorders
Headache
|
28.3%
17/60 • 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.
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.
|
17.4%
8/46 • 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.
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.
|
29.3%
17/58 • 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.
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.
|
24.4%
10/41 • 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.
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.
|
22.4%
11/49 • 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.
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.
|
30.6%
22/72 • 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.
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.
|
10.0%
4/40 • 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.
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.
|
41.7%
25/60 • 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.
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.
|
12.5%
5/40 • 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.
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.
|
|
Infections and infestations
Joint pain
|
20.0%
12/60 • 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.
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.
|
4.3%
2/46 • 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.
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.
|
32.8%
19/58 • 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.
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.
|
9.8%
4/41 • 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.
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.
|
10.2%
5/49 • 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.
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.
|
22.2%
16/72 • 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.
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.
|
2.5%
1/40 • 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.
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.
|
16.7%
10/60 • 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.
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.
|
10.0%
4/40 • 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.
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.
|
|
General disorders
Muscle aches
|
35.0%
21/60 • 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.
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.
|
17.4%
8/46 • 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.
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.
|
48.3%
28/58 • 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.
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.
|
19.5%
8/41 • 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.
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.
|
20.4%
10/49 • 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.
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.
|
40.3%
29/72 • 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.
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.
|
7.5%
3/40 • 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.
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.
|
28.3%
17/60 • 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.
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.
|
17.5%
7/40 • 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.
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.
|
|
General disorders
Shivering
|
11.7%
7/60 • 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.
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.
|
2.2%
1/46 • 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.
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.
|
15.5%
9/58 • 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.
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.
|
4.9%
2/41 • 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.
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.
|
6.1%
3/49 • 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.
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.
|
12.5%
9/72 • 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.
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.
|
2.5%
1/40 • 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.
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.
|
13.3%
8/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
General disorders
Sweating
|
5.0%
3/60 • 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.
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.
|
2.2%
1/46 • 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.
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.
|
10.3%
6/58 • 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.
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.
|
4.9%
2/41 • 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.
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.
|
8.2%
4/49 • 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.
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.
|
5.6%
4/72 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
8.3%
5/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
General disorders
Fever
|
6.7%
4/60 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
6.9%
4/58 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
1.4%
1/72 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
Nervous system disorders
Headache
|
9.8%
6/61 • 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.
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.
|
2.2%
1/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
4.9%
2/41 • 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.
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.
|
6.1%
3/49 • 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.
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.
|
5.6%
4/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
1.7%
1/60 • 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.
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.
|
2.5%
1/40 • 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.
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.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
2/61 • 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.
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.
|
2.2%
1/46 • 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.
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.
|
5.1%
3/59 • 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.
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.
|
2.4%
1/41 • 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.
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.
|
2.0%
1/49 • 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.
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.
|
4.2%
3/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
8.3%
5/60 • 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.
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.
|
2.5%
1/40 • 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.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
2/61 • 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.
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.
|
6.5%
3/46 • 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.
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.
|
5.1%
3/59 • 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.
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.
|
2.4%
1/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
2.8%
2/72 • 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.
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.
|
2.4%
1/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
2.5%
1/40 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
9.8%
4/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
2.8%
2/72 • 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.
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.
|
2.4%
1/41 • 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.
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.
|
1.7%
1/60 • 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.
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.
|
2.5%
1/40 • 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.
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/61 • 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.
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.
|
2.2%
1/46 • 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.
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.
|
1.7%
1/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
2.4%
1/41 • 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.
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.
|
5.0%
3/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
1.4%
1/72 • 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.
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.
|
4.9%
2/41 • 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.
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.
|
5.0%
3/60 • 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.
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.
|
0.00%
0/40 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
1.7%
1/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
4.1%
2/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
5.0%
2/40 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/61 • 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.
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.
|
0.00%
0/46 • 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.
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.
|
0.00%
0/59 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/49 • 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.
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.
|
0.00%
0/72 • 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.
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.
|
0.00%
0/41 • 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.
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.
|
0.00%
0/60 • 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.
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.
|
5.0%
2/40 • 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.
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER