Trial Outcomes & Findings for Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) (NCT NCT00989612)
NCT ID: NCT00989612
Last Updated: 2019-01-16
Results Overview
Titers are presented as geometric mean titers (GMTs).
COMPLETED
PHASE2
100 participants
At Day 0
2019-01-16
Participant Flow
Participant milestones
| Measure |
GSK2340274A Group
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
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|---|---|
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Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
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Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)
Baseline characteristics by cohort
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
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|---|---|
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Age, Continuous
|
39.3 Years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
Titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
|
8.8 Titers
Interval 7.3 to 10.5
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
Titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
|
230.3 Titers
Interval 177.7 to 298.4
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
Titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
|
485.0 Titers
Interval 420.3 to 559.7
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
|
43 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
|
100 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
|
100 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
|
94 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
|
100 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
|
95 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
|
100 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
|
26.3 Fold change
Interval 20.6 to 33.5
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
|
55.4 Fold change
Interval 45.6 to 67.2
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 21, 42 and 182Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Outcome measures
| Measure |
GSK2340274A Group
n=50 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
n=50 Participants
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Day 0
|
22 Participants
|
21 Participants
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Day 21
|
50 Participants
|
50 Participants
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Day 42
|
50 Participants
|
50 Participants
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Day 182
|
50 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 21, 42 and 182Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
Titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK2340274A Group
n=50 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
n=50 Participants
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 0
|
8.9 Titers
Interval 7.1 to 11.1
|
8.9 Titers
Interval 6.8 to 10.9
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 21
|
258.3 Titers
Interval 191.3 to 348.7
|
205.3 Titers
Interval 145.4 to 290.0
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 42
|
505.6 Titers
Interval 427.9 to 597.6
|
465.3 Titers
Interval 384.5 to 563.0
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 182
|
182.6 Titers
Interval 141.1 to 236.4
|
167.9 Titers
Interval 124.5 to 226.5
|
SECONDARY outcome
Timeframe: At Days 21, 42 and 182Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Outcome measures
| Measure |
GSK2340274A Group
n=50 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
n=50 Participants
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 21
|
50 Participants
|
44 Participants
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 42
|
50 Participants
|
50 Participants
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 182
|
48 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 21, 42 and 182Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Outcome measures
| Measure |
GSK2340274A Group
n=50 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
n=50 Participants
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Day 0
|
3 Participants
|
3 Participants
|
|
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Day 21
|
50 Participants
|
45 Participants
|
|
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Day 42
|
50 Participants
|
50 Participants
|
|
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Day 182
|
49 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: At Days 21, 42 and 182Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Outcome measures
| Measure |
GSK2340274A Group
n=50 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
n=50 Participants
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 21
|
29.1 Fold change
Interval 21.8 to 38.9
|
23.8 Fold change
Interval 17.4 to 32.6
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 42
|
57.0 Fold change
Interval 44.3 to 73.2
|
53.9 Fold change
Interval 42.6 to 68.1
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Day 182
|
20.6 Fold change
Interval 16.0 to 26.5
|
19.4 Fold change
Interval 15.1 to 25.1
|
SECONDARY outcome
Timeframe: At Days 0, 21, 42 and 182Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
Titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK2340274A Group
n=50 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
n=50 Participants
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 0
|
8.7 Titers
Interval 6.6 to 11.4
|
8.4 Titers
Interval 6.6 to 10.7
|
|
Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 21
|
146.6 Titers
Interval 90.1 to 238.6
|
127.8 Titers
Interval 77.1 to 211.9
|
|
Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 42
|
336.6 Titers
Interval 247.8 to 457.1
|
277.7 Titers
Interval 194.3 to 397.0
|
|
Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 182
|
133.5 Titers
Interval 97.3 to 183.1
|
98.0 Titers
Interval 66.6 to 144.3
|
SECONDARY outcome
Timeframe: At Days 0, 21, 42 and 182Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
GSK2340274A Group
n=50 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
n=50 Participants
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 0
|
24 Participants
|
27 Participants
|
|
Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 21
|
47 Participants
|
49 Participants
|
|
Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 42
|
50 Participants
|
50 Participants
|
|
Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 182
|
50 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: At Days 21, 42 and 182Population: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.
A seroconverted subject was defined as a vaccinated subject with a minimum 4-fold increase in post vaccination neutralizing titer.
Outcome measures
| Measure |
GSK2340274A Group
n=50 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
n=50 Participants
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 21
|
39 Participants
|
35 Participants
|
|
Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 42
|
48 Participants
|
48 Participants
|
|
Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Day 182
|
42 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: During a 7-day (Days 0-6) follow-up after each vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Any, Dose 1
|
98 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Grade 3, Dose 1
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Any, Dose 1
|
7 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Grade 3, Dose 1
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Any, Dose 1
|
17 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Grade 3, Dose 1
|
2 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Any, Dose 2
|
93 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Grade 3, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Any, Dose 2
|
8 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Grade 3, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Any, Dose 2
|
17 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Grade 3, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Any, Across doses
|
99 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Grade 3, Across doses
|
5 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Any, Across doses
|
13 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Grade 3, Across doses
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Any, Across doses
|
24 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Grade 3, Across doses
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: During a 7-day (Days 0-6) follow-up after each vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Any, Dose 1
|
46 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Grade 3, Dose 1
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Related, Dose 1
|
45 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Any, Dose 1
|
35 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Grade 3, Dose 1
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Related, Dose 1
|
34 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Joint pain at other location, Any, Dose 1
|
14 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Joint pain at other location, Grade 3, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Joint pain at other location, Related, Dose 1
|
14 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Muscle aches, Any, Dose 1
|
44 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Muscle aches, Grade 3, Dose 1
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Muscle aches, Related, Dose 1
|
44 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Shivering, Any, Dose 1
|
19 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Shivering, Grade 3, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Shivering, Related, Dose 1
|
19 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Sweating, Any, Dose 1
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Sweating, Grade 3, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Sweating, Related, Dose 1
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Temperature (Axillary), Any, Dose 1
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Temperature (Axillary), Grade 3, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Temperature (Axillary), Related, Dose 1
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Any, Dose 2
|
54 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Grade 3, Dose 2
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Related, Dose 2
|
54 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Any, Dose 2
|
39 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Grade 3, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Related, Dose 2
|
37 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Joint pain at other location, Any, Dose 2
|
30 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Joint pain at other location, Grade 3, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Joint pain at other location, Related, Dose 2
|
30 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Muscle aches, Any, Dose 2
|
51 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Muscle aches, Grade 3, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Muscle aches, Related, Dose 2
|
51 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Shivering, Any, Dose 2
|
29 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Shivering, Grade 3, Dose 2
|
4 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Shivering, Related, Dose 2
|
29 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Sweating, Any, Dose 2
|
9 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Sweating, Grade 3, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Sweating, Related, Dose 2
|
9 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Temperature (Axillary), Any, Dose 2
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Temperature (Axillary), Grade 3, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Temperature (Axillary), Related, Dose 2
|
6 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Any, Across doses
|
69 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Grade 3, Across doses
|
5 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fatigue, Related, Across doses
|
68 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Any, Across doses
|
51 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Grade 3, Across doses
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Headache, Related, Across doses
|
49 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Joint pain at other location, Any, Across doses
|
33 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Joint pain at other location, Grade 3, Across dose
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Joint pain at other location, Related, Across dose
|
33 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Muscle aches, Any, Across doses
|
59 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Muscle aches, Grade 3, Across doses
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Muscle aches, Related, Across doses
|
59 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Shivering, Any, Across doses
|
37 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Shivering, Grade 3, Across doses
|
4 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Shivering, Related, Across doses
|
37 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Sweating, Any, Across doses
|
13 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Sweating, Grade 3, Across doses
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Sweating, Related, Across doses
|
13 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Temperature (Axillary), Any, Across doses
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Temperature (Axillary), Grade 3, Across doses
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Temperature (Axillary), Related, Across doses
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Subjects with any AE(s)
|
46 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Subjects with grade 3 AE(s)
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Subjects with related AE(s)
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0-182)Population: Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0-182)Population: Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During a 7-day (Days 0-6) follow-up after each vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited local symptom was assessed in subjects who have reported at least once the symptom.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Days With Any Solicited Local Symptoms
Pain, Dose 1
|
4 Days
Interval 1.0 to 7.0
|
—
|
|
Number of Days With Any Solicited Local Symptoms
Redness, Dose 1
|
3 Days
Interval 1.0 to 6.0
|
—
|
|
Number of Days With Any Solicited Local Symptoms
Swelling, Dose 1
|
3 Days
Interval 1.0 to 7.0
|
—
|
|
Number of Days With Any Solicited Local Symptoms
Pain, Dose 2
|
3 Days
Interval 1.0 to 7.0
|
—
|
|
Number of Days With Any Solicited Local Symptoms
Redness, Dose 2
|
3 Days
Interval 1.0 to 6.0
|
—
|
|
Number of Days With Any Solicited Local Symptoms
Swelling, Dose 2
|
3 Days
Interval 1.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: During a 7-day (Days 0-6) follow-up after each vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited general symptom was assessed in subjects who have reported at least once the symptom.
Outcome measures
| Measure |
GSK2340274A Group
n=100 Participants
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340274A 41-64Y Group
Healthy subjects, aged 41 to 64 years (Y), male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Number of Days With Any Solicited General Symptoms
Fatigue, Dose 1
|
2 Days
Interval 1.0 to 6.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Headache, Dose 1
|
1 Days
Interval 1.0 to 6.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Joint pain at other location, Dose 1
|
2 Days
Interval 1.0 to 5.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Muscle aches, Dose 1
|
3 Days
Interval 1.0 to 6.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Sweating, Dose 1
|
1 Days
Interval 1.0 to 6.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Shivering, Dose 1
|
1 Days
Interval 1.0 to 3.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Fatigue, Dose 2
|
2 Days
Interval 1.0 to 7.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Headache, Dose 2
|
1 Days
Interval 1.0 to 7.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Joint pain at other location, Dose 2
|
2 Days
Interval 1.0 to 6.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Muscle aches, Dose 2
|
3 Days
Interval 1.0 to 7.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Sweating, Dose 2
|
1 Days
Interval 1.0 to 4.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Shivering, Dose 2
|
1 Days
Interval 1.0 to 3.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Temperature, Dose 2
|
1 Days
Interval 1.0 to 2.0
|
—
|
|
Number of Days With Any Solicited General Symptoms
Temperature, Dose 1
|
1 Days
Interval 1.0 to 1.0
|
—
|
Adverse Events
GSK2340274A Group
Serious adverse events
| Measure |
GSK2340274A Group
n=100 participants at risk
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|
|
Renal and urinary disorders
Calculus ureteric
|
1.0%
1/100 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
1.0%
1/100 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
Infections and infestations
Viral infection
|
1.0%
1/100 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
Other adverse events
| Measure |
GSK2340274A Group
n=100 participants at risk
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.0%
33/100 • Number of events 44 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
General disorders
Chills
|
37.0%
37/100 • Number of events 48 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
5/100 • Number of events 5 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
13.0%
13/100 • Number of events 15 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
General disorders
Fatigue
|
69.0%
69/100 • Number of events 100 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
Nervous system disorders
Headache
|
53.0%
53/100 • Number of events 79 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.0%
13/100 • Number of events 16 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
59.0%
59/100 • Number of events 95 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
5/100 • Number of events 9 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
General disorders
Pain
|
99.0%
99/100 • Number of events 191 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
General disorders
Pyrexia
|
10.0%
10/100 • Number of events 13 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
|
General disorders
Swelling
|
24.0%
24/100 • Number of events 34 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
|
Additional Information
GSK Response Center
GlaxoSmithKline
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