Trial Outcomes & Findings for Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults (NCT NCT00989287)
NCT ID: NCT00989287
Last Updated: 2019-06-26
Results Overview
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
At Day 21
Results posted on
2019-06-26
Participant Flow
Participant milestones
| Measure |
GSK2340272A Group
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
66
|
|
Overall Study
COMPLETED
|
64
|
65
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
GSK2340272A Group
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults
Baseline characteristics by cohort
| Measure |
GSK2340272A Group
n=65 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=66 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 Years
STANDARD_DEVIATION 14.29 • n=5 Participants
|
38.4 Years
STANDARD_DEVIATION 13.61 • n=7 Participants
|
37.70 Years
STANDARD_DEVIATION 13.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian-East Asian heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White-Caucasian/European heritage
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Outcome measures
| Measure |
GSK2340272A Group
n=64 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=63 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain
|
60 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
Outcome measures
| Measure |
GSK2340272A Group
n=64 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=63 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
|
60 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A Group
n=64 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=63 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
|
44.4 Fold change
Interval 33.6 to 58.7
|
11.4 Fold change
Interval 8.1 to 16.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.
Outcome measures
| Measure |
GSK2340272A Group
n=29 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=20 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 0
|
29 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 21
|
29 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 42
|
29 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
Outcome measures
| Measure |
GSK2340272A Group
n=64 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=63 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered 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 the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 0
|
9.6 Titers
Interval 7.6 to 12.0
|
8.4 Titers
Interval 6.7 to 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 21
|
424.0 Titers
Interval 312.4 to 575.5
|
96.4 Titers
Interval 64.0 to 145.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 42
|
686.7 Titers
Interval 567.0 to 831.7
|
149.7 Titers
Interval 108.0 to 207.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.
Outcome measures
| Measure |
GSK2340272A Group
n=17 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=13 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=12 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=7 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=4 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=5 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
n=8 Participants
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
n=2 Participants
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 0
|
17 Participants
|
13 Participants
|
12 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 21
|
17 Participants
|
13 Participants
|
12 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 42
|
17 Participants
|
13 Participants
|
12 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
Outcome measures
| Measure |
GSK2340272A Group
n=32 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=31 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=32 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=32 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
n=16 Participants
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 0
|
12.4 Titers
Interval 8.2 to 18.7
|
10.9 Titers
Interval 7.2 to 16.5
|
7.4 Titers
Interval 6.1 to 8.9
|
6.5 Titers
Interval 5.3 to 8.1
|
6.3 Titers
Interval 5.0 to 8.1
|
7.5 Titers
Interval 5.1 to 11.2
|
8.6 Titers
Interval 6.3 to 11.7
|
5.7 Titers
Interval 4.7 to 6.9
|
|
Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 42
|
895.4 Titers
Interval 714.7 to 1121.8
|
216.2 Titers
Interval 134.8 to 346.8
|
526.7 Titers
Interval 393.1 to 705.6
|
104.9 Titers
Interval 67.4 to 163.2
|
462.5 Titers
Interval 340.9 to 627.5
|
170.8 Titers
Interval 94.4 to 308.8
|
599.7 Titers
Interval 352.3 to 1020.8
|
64.4 Titers
Interval 34.6 to 120.0
|
|
Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 21
|
705.7 Titers
Interval 523.8 to 950.7
|
171.1 Titers
Interval 96.7 to 302.8
|
254.8 Titers
Interval 156.7 to 414.4
|
55.4 Titers
Interval 32.0 to 95.7
|
287.1 Titers
Interval 164.1 to 502.1
|
123.3 Titers
Interval 59.5 to 255.5
|
226.2 Titers
Interval 95.3 to 536.6
|
24.8 Titers
Interval 12.9 to 47.9
|
SECONDARY outcome
Timeframe: At Days 182 and 364Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.
A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.
Outcome measures
| Measure |
GSK2340272A Group
n=64 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=63 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 182
|
64 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 364
|
60 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 182 and 364Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.
Outcome measures
| Measure |
GSK2340272A Group
n=64 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=63 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Titers for Serum HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 182
|
222.6 Titers
Interval 172.4 to 287.4
|
80.4 Titers
Interval 55.1 to 117.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Serum HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 364
|
76.8 Titers
Interval 58.1 to 101.5
|
35.2 Titers
Interval 24.0 to 51.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 182 and 364Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.
A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.
Outcome measures
| Measure |
GSK2340272A Group
n=32 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=31 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 182
|
32 Participants
|
29 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
14 Participants
|
—
|
—
|
|
Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 364
|
30 Participants
|
26 Participants
|
16 Participants
|
14 Participants
|
14 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 182 and 364Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
Outcome measures
| Measure |
GSK2340272A Group
n=32 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=31 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 182
|
269.1 Titers
Interval 183.9 to 393.9
|
132.3 Titers
Interval 75.9 to 230.4
|
182.2 Titers
Interval 126.8 to 261.7
|
99.3 Titers
Interval 47.8 to 206.6
|
186.1 Titers
Interval 97.5 to 355.4
|
24.8 Titers
Interval 15.6 to 39.6
|
—
|
—
|
|
Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 364
|
96.2 Titers
Interval 63.1 to 146.7
|
57.2 Titers
Interval 32.2 to 101.8
|
57.7 Titers
Interval 38.4 to 86.8
|
48.4 Titers
Interval 23.2 to 101.1
|
66.4 Titers
Interval 33.1 to 133.2
|
10.6 Titers
Interval 6.8 to 16.7
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Outcome measures
| Measure |
GSK2340272A Group
n=32 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=31 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 21
|
32 Participants
|
25 Participants
|
16 Participants
|
12 Participants
|
12 Participants
|
7 Participants
|
—
|
—
|
|
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 42
|
32 Participants
|
27 Participants
|
16 Participants
|
15 Participants
|
16 Participants
|
12 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 182 and 364Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Outcome measures
| Measure |
GSK2340272A Group
n=64 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=63 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 182
|
60 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted (SCR) Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 364
|
44 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 182 and 364Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.
Seroconversion was defined as: For initially seronegative subjects (antibody titer \< 10 post-vaccination), antibody titer ≥ 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Outcome measures
| Measure |
GSK2340272A Group
n=32 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=31 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 182
|
30 Participants
|
25 Participants
|
16 Participants
|
11 Participants
|
14 Participants
|
6 Participants
|
—
|
—
|
|
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 364
|
23 Participants
|
14 Participants
|
11 Participants
|
6 Participants
|
10 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
Outcome measures
| Measure |
GSK2340272A Group
n=32 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=31 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=32 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=32 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
n=16 Participants
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 42
|
32 Participants
|
28 Participants
|
32 Participants
|
28 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
|
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 0
|
7 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 21
|
32 Participants
|
26 Participants
|
28 Participants
|
20 Participants
|
16 Participants
|
13 Participants
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At Days 182 and 364Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.
Outcome measures
| Measure |
GSK2340272A Group
n=32 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=31 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 182
|
32 Participants
|
26 Participants
|
16 Participants
|
12 Participants
|
14 Participants
|
7 Participants
|
—
|
—
|
|
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Flu A/CAL/7/09, Day 364
|
26 Participants
|
17 Participants
|
11 Participants
|
7 Participants
|
11 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.
GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A Group
n=32 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=31 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 42
|
72.2 Fold change
Interval 49.3 to 105.9
|
19.8 Fold change
Interval 13.2 to 29.7
|
72.9 Fold change
Interval 52.9 to 100.6
|
22.7 Fold change
Interval 11.9 to 43.1
|
70.1 Fold change
Interval 41.9 to 117.4
|
11.3 Fold change
Interval 6.1 to 20.9
|
—
|
—
|
|
Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 21
|
56.9 Fold change
Interval 38.9 to 83.4
|
15.7 Fold change
Interval 9.6 to 25.6
|
45.3 Fold change
Interval 27.8 to 73.6
|
16.4 Fold change
Interval 7.9 to 33.9
|
26.4 Fold change
Interval 13.2 to 52.9
|
4.4 Fold change
Interval 2.4 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 182 and 364Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.
GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A Group
n=32 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=31 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
n=16 Participants
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
n=16 Participants
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 182
|
21.7 Fold change
Interval 15.4 to 30.6
|
12.1 Fold change
Interval 7.7 to 19.0
|
28.7 Fold change
Interval 19.1 to 43.2
|
13.2 Fold change
Interval 6.3 to 27.6
|
21.8 Fold change
Interval 12.7 to 37.2
|
4.4 Fold change
Interval 2.8 to 6.8
|
—
|
—
|
|
Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Flu A/CAL/7/09, Day 364
|
8.4 Fold change
Interval 5.5 to 12.8
|
5.6 Fold change
Interval 3.5 to 8.9
|
9.1 Fold change
Interval 5.7 to 14.5
|
6.4 Fold change
Interval 3.1 to 13.4
|
8.0 Fold change
Interval 4.7 to 13.8
|
1.9 Fold change
Interval 1.2 to 2.9
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK2340272A Group
n=65 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=66 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered 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
Any Pain, Dose 1
|
60 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
57 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
62 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
The number of days with any solicited local symptoms reported during the solicited post-vaccination period. No subjects in GSK2340269A Group reported redness or swelling.
Outcome measures
| Measure |
GSK2340272A Group
n=117 Doses with the symptom
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=27 Doses with the symptom
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered 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 Solicited Local Symptoms
Pain, Dose 1
|
3.0 Days
Interval 3.0 to 4.0
|
2.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Pain, Dose 2
|
3.0 Days
Interval 2.0 to 4.0
|
2.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Pain, Overall/dose
|
3.0 Days
Interval 2.0 to 4.0
|
2.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Redness, Dose 1
|
2.0 Days
Interval 1.5 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Redness, Dose 2
|
2.5 Days
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Redness, Overall/dose
|
2.0 Days
Interval 2.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Swelling, Dose 1
|
1.5 Days
Interval 1.0 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Swelling, Dose 2
|
2.0 Days
Interval 2.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Swelling, Overall/dose
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2340272A Group
n=65 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=66 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered 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
Any Headache, Dose 1
|
25 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
22 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
31 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
28 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Joint pain, Dose 1
|
13 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Joint pain, Dose 1
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 1
|
9 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Joint pain, Dose 1
|
12 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Muscle aches, Dose 1
|
17 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Muscle aches, Dose 1
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Muscle aches, Dose 1
|
16 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 1
|
9 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 1
|
9 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 1
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
28 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
27 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
21 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
20 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Joint pain, Dose 2
|
12 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Joint pain, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Joint pain, Dose 2
|
12 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Muscle aches, Dose 2
|
22 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Muscle aches, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Muscle aches, Dose 2
|
22 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 2
|
12 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 2
|
12 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 2
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 2
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across doses
|
38 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across doses
|
35 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across doses
|
37 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across doses
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across doses
|
35 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Joint pain, Across doses
|
22 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Joint pain, Across doses
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Joint pain, Across doses
|
21 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Muscle aches, Across doses
|
32 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Muscle aches, Across doses
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Muscle aches, Across doses
|
31 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Across doses
|
17 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Across doses
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Across doses
|
17 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Across doses
|
15 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Across doses
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Across doses
|
15 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across doses
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across doses
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across doses
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
The number of days with any solicited general symptoms reported during the solicited post-vaccination period. No subjects from the GSK2340269A Group reported any temperature after Dose 2.
Outcome measures
| Measure |
GSK2340272A Group
n=59 Doses with the symptom
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=37 Doses with the symptom
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered 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 Solicited General Symptoms
Fatigue, Dose 1
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Fatigue, Dose 2
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Fatigue, Overall/dose
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Headache, Dose 1
|
2.0 Days
Interval 1.0 to 3.0
|
1.5 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Headache, Dose 2
|
1.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Headache, Overall/dose
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Joint pain, Dose 1
|
1.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Joint pain, Dose 2
|
2.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 2.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Joint pain, Overall/dose
|
2.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Muscle aches, Dose 1
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Muscle aches, Dose 2
|
2.0 Days
Interval 1.0 to 3.0
|
1.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Muscle aches, Overall/dose
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Sweating, Dose 1
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Sweating, Dose 2
|
2.0 Days
Interval 1.0 to 4.0
|
2.0 Days
Interval 2.0 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Sweating, Overall/dose
|
2.0 Days
Interval 1.0 to 4.0
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Shivering, Dose 1
|
1.0 Days
Interval 1.0 to 2.0
|
1.5 Days
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Shivering, Dose 2
|
1.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Shivering, Overall/dose
|
1.0 Days
Interval 1.0 to 2.0
|
1.5 Days
Interval 1.0 to 3.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Temperature, Dose 1
|
1.5 Days
Interval 1.0 to 2.0
|
1.5 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Temperature, Dose 2
|
1.0 Days
Interval 1.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Temperature, Overall/dose
|
1.0 Days
Interval 1.0 to 2.0
|
1.5 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 364Population: The 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 |
GSK2340272A Group
n=65 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=66 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered 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 Adverse Events of Specific Interest (AESIs)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)Population: The 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 |
GSK2340272A Group
n=65 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=66 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered 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)
Any AE(s), Days 0-20
|
25 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s), Days 0-20
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s), Days 0-20
|
11 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s), up to Day 84
|
48 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s), up to Day 84
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s), up to Day 84
|
15 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Day 364)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
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 |
GSK2340272A Group
n=65 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=66 Participants
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-60y)
Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (41-50y)
Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340272A (51-60y)
Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A (51-60y)
Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered 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)
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
GSK2340272A Group
Serious events: 4 serious events
Other events: 63 other events
Deaths: 0 deaths
GSK2340269A Group
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK2340272A Group
n=65 participants at risk
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=66 participants at risk
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
1.5%
1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
1.5%
1/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Nervous system disorders
Balance disorder
|
1.5%
1/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
1.5%
1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.5%
1/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
1.5%
1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
1.5%
1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Renal and urinary disorders
Renal disorder
|
1.5%
1/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
1.5%
1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Injury, poisoning and procedural complications
Open wound
|
1.5%
1/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
1.5%
1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Infections and infestations
Sepsis
|
1.5%
1/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
Other adverse events
| Measure |
GSK2340272A Group
n=65 participants at risk
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
|
GSK2340269A Group
n=66 participants at risk
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered 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
|
35.4%
23/65 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
10.6%
7/66 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Chills
|
26.2%
17/65 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
10.6%
7/66 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
13.8%
9/65 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Fatigue
|
58.5%
38/65 • Number of events 60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
47.0%
31/66 • Number of events 41 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Infections and infestations
Gastroenteritis
|
6.2%
4/65 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
4.5%
3/66 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Nervous system disorders
Headache
|
60.0%
39/65 • Number of events 53 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
36.4%
24/66 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
23.1%
15/65 • Number of events 17 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
18.2%
12/66 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Influenza like illness
|
4.6%
3/65 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
6.1%
4/66 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
49.2%
32/65 • Number of events 40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
13.6%
9/66 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Pain
|
95.4%
62/65 • Number of events 117 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
31.8%
21/66 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Pyrexia
|
7.7%
5/65 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
6.1%
4/66 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Infections and infestations
Rhinitis
|
4.6%
3/65 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
9.1%
6/66 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Swelling
|
16.9%
11/65 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
Infections and infestations
Upper respiratory tract infection
|
21.5%
14/65 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
12.1%
8/66 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Redness
|
13.8%
9/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Joint Pain ar other location
|
33.8%
22/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
7.6%
5/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Muscle aches
|
49.2%
32/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
13.6%
9/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Shivering
|
26.2%
17/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
10.6%
7/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
|
General disorders
Sweating
|
23.1%
15/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
18.2%
12/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
|
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