Trial Outcomes & Findings for Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A) (NCT NCT00430521)
NCT ID: NCT00430521
Last Updated: 2019-10-28
Results Overview
The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.
COMPLETED
PHASE2
512 participants
At Day 0
2019-10-28
Participant Flow
Participant milestones
| Measure |
GSK1562902A V/I/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
66
|
64
|
63
|
64
|
64
|
65
|
63
|
|
Overall Study
COMPLETED
|
52
|
57
|
61
|
55
|
59
|
59
|
55
|
51
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
3
|
8
|
5
|
5
|
10
|
12
|
Reasons for withdrawal
| Measure |
GSK1562902A V/I/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
3
|
5
|
5
|
2
|
8
|
10
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Vaccine Expired
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
3
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)
Baseline characteristics by cohort
| Measure |
GSK1562902A V/I/6 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=66 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
n=65 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
Total
n=512 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.6 Years
STANDARD_DEVIATION 12.9 • n=39 Participants
|
33.1 Years
STANDARD_DEVIATION 11.4 • n=41 Participants
|
33.8 Years
STANDARD_DEVIATION 11.8 • n=35 Participants
|
33.4 Years
STANDARD_DEVIATION 12.4 • n=31 Participants
|
34.6 Years
STANDARD_DEVIATION 12.9 • n=146 Participants
|
34.8 Years
STANDARD_DEVIATION 12.9 • n=19 Participants
|
33.2 Years
STANDARD_DEVIATION 11.2 • n=147 Participants
|
34.3 Years
STANDARD_DEVIATION 11.6 • n=193 Participants
|
34.0 Years
STANDARD_DEVIATION 12.1
|
|
Sex: Female, Male
Female
|
32 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
37 Participants
n=31 Participants
|
37 Participants
n=146 Participants
|
27 Participants
n=19 Participants
|
36 Participants
n=147 Participants
|
36 Participants
n=193 Participants
|
273 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
27 Participants
n=146 Participants
|
37 Participants
n=19 Participants
|
29 Participants
n=147 Participants
|
27 Participants
n=193 Participants
|
239 Participants
|
|
Race/Ethnicity, Customized
Caucasian / European heritage
|
63 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
61 Participants
n=31 Participants
|
64 Participants
n=146 Participants
|
61 Participants
n=19 Participants
|
63 Participants
n=147 Participants
|
62 Participants
n=193 Participants
|
500 Participants
|
|
Race/Ethnicity, Customized
Others
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
1 Participants
n=193 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=56 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=50 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
A/Indonesia, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
A/Vietnam, Day 0
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
A/Vietnam, Month 6
|
25 Participants
|
18 Participants
|
35 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
A/Indonesia, Month 6
|
4 Participants
|
2 Participants
|
18 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 7 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=45 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
A/Indonesia, Month 6 + 7 Days
|
52 Participants
|
37 Participants
|
41 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
A/Vietnam, Month 6 + 7 Days
|
52 Participants
|
42 Participants
|
43 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=52 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
A/Indonesia, Month 6 + 21 Days
|
51 Participants
|
41 Participants
|
47 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
A/Vietnam, Month 6 + 21 Days
|
51 Participants
|
43 Participants
|
47 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=56 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=50 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
A/Indonesia, Day 0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
A/Vietnam, Day 0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.3 Titers
Interval 4.9 to 5.7
|
5.2 Titers
Interval 4.8 to 5.7
|
5.7 Titers
Interval 4.7 to 7.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
A/Vietnam, Month 6
|
12.0 Titers
Interval 8.9 to 16.1
|
9.7 Titers
Interval 7.4 to 12.7
|
29.9 Titers
Interval 20.1 to 44.4
|
32.0 Titers
Interval 21.3 to 48.0
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
A/Indonesia, Month 6
|
5.5 Titers
Interval 5.0 to 6.0
|
5.3 Titers
Interval 4.9 to 5.7
|
8.6 Titers
Interval 6.6 to 11.3
|
7.2 Titers
Interval 6.0 to 8.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 7 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=45 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
A/Indonesia, Month 6 + 7 days
|
152.9 Titers
Interval 112.2 to 208.2
|
64.6 Titers
Interval 41.3 to 101.1
|
120.0 Titers
Interval 76.8 to 187.6
|
65.0 Titers
Interval 42.1 to 100.2
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
A/Vietnam, Month 6 + 7 days
|
226.3 Titers
Interval 168.3 to 304.3
|
202.6 Titers
Interval 130.7 to 314.1
|
182.7 Titers
Interval 118.5 to 281.7
|
224.5 Titers
Interval 144.9 to 347.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=52 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
A/Indonesia, Month 6 + 21 Days
|
303.4 Titers
Interval 215.7 to 426.6
|
92.4 Titers
Interval 61.1 to 139.9
|
392.9 Titers
Interval 256.7 to 601.4
|
127.7 Titers
Interval 83.8 to 194.6
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
A/Vietnam, Month 6 + 21 Days
|
434.7 Titers
Interval 314.8 to 600.5
|
287.2 Titers
Interval 180.3 to 457.5
|
571.4 Titers
Interval 366.3 to 891.3
|
380.5 Titers
Interval 240.2 to 602.9
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6
|
1.1 Fold Increase
Interval 1.0 to 1.2
|
1.1 Fold Increase
Interval 1.0 to 1.1
|
1.7 Fold Increase
Interval 1.3 to 2.3
|
1.4 Fold Increase
Interval 1.2 to 1.7
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6
|
2.4 Fold Increase
Interval 1.8 to 3.2
|
1.8 Fold Increase
Interval 1.4 to 2.4
|
6.0 Fold Increase
Interval 4.0 to 8.9
|
5.6 Fold Increase
Interval 3.8 to 8.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 7 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=45 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 7 Days
|
30.6 Fold Increase
Interval 22.4 to 41.6
|
12.9 Fold Increase
Interval 8.3 to 20.2
|
24.0 Fold Increase
Interval 15.4 to 37.5
|
13.0 Fold Increase
Interval 8.4 to 20.0
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 7 Days
|
45.3 Fold Increase
Interval 33.7 to 60.9
|
38.2 Fold Increase
Interval 23.7 to 56.3
|
36.5 Fold Increase
Interval 23.7 to 56.3
|
38.8 Fold Increase
Interval 24.7 to 60.9
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=52 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 21 Days
|
60.7 Fold Increase
Interval 43.1 to 85.3
|
18.5 Fold Increase
Interval 12.2 to 28.0
|
78.6 Fold Increase
Interval 51.3 to 120.3
|
25.5 Fold Increase
Interval 16.8 to 38.9
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 21 Days
|
86.9 Fold Increase
Interval 63.0 to 120.1
|
54.2 Fold Increase
Interval 33.8 to 87.1
|
114.3 Fold Increase
Interval 73.3 to 178.3
|
66.0 Fold Increase
Interval 41.2 to 105.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6
|
14 Participants
|
6 Participants
|
26 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 7 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=45 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 7 Days
|
49 Participants
|
35 Participants
|
40 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 7 Days
|
52 Participants
|
42 Participants
|
42 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=52 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 21 Days
|
51 Participants
|
40 Participants
|
46 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 21 Days
|
51 Participants
|
43 Participants
|
46 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=56 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=50 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Day 0
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6
|
14 Participants
|
7 Participants
|
26 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 7 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=45 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 7 Days
|
49 Participants
|
35 Participants
|
40 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 7 Days
|
52 Participants
|
42 Participants
|
42 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=52 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 21 Days
|
51 Participants
|
40 Participants
|
46 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 21 Days
|
51 Participants
|
43 Participants
|
46 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 6/12 months + 7 daysPopulation: This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in. The data for Dose 3 were not collected from subjects who did not receive the booster dose, given at either Month 6 or Month 12.
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=62 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=66 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=62 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
n=65 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Ecchymosis, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
7 Participants
|
12 Participants
|
10 Participants
|
10 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Ecchymosis, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Induration, Across doses
|
17 Participants
|
13 Participants
|
22 Participants
|
25 Participants
|
14 Participants
|
16 Participants
|
24 Participants
|
19 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Induration, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
56 Participants
|
62 Participants
|
61 Participants
|
59 Participants
|
61 Participants
|
57 Participants
|
62 Participants
|
58 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
6 Participants
|
6 Participants
|
5 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
11 Participants
|
8 Participants
|
16 Participants
|
13 Participants
|
8 Participants
|
11 Participants
|
13 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
12 Participants
|
15 Participants
|
21 Participants
|
22 Participants
|
10 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Ecchymosis, Dose 1
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Induration, Dose 1
|
9 Participants
|
9 Participants
|
10 Participants
|
20 Participants
|
7 Participants
|
9 Participants
|
14 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Induration, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
50 Participants
|
61 Participants
|
54 Participants
|
56 Participants
|
53 Participants
|
52 Participants
|
57 Participants
|
54 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
4 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
7 Participants
|
7 Participants
|
7 Participants
|
14 Participants
|
5 Participants
|
10 Participants
|
8 Participants
|
9 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Ecchymosis, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Ecchymosis, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Induration, Dose 2
|
13 Participants
|
11 Participants
|
9 Participants
|
14 Participants
|
11 Participants
|
11 Participants
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Induration, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
46 Participants
|
49 Participants
|
50 Participants
|
49 Participants
|
54 Participants
|
47 Participants
|
49 Participants
|
47 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
4 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
9 Participants
|
8 Participants
|
11 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Ecchymosis, Dose 3
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Ecchymosis, Dose 3
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Induration, Dose 3
|
—
|
—
|
16 Participants
|
13 Participants
|
—
|
—
|
15 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Induration, Dose 3
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
—
|
—
|
53 Participants
|
51 Participants
|
—
|
—
|
48 Participants
|
44 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
—
|
—
|
5 Participants
|
5 Participants
|
—
|
—
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
—
|
—
|
8 Participants
|
7 Participants
|
—
|
—
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
—
|
—
|
15 Participants
|
13 Participants
|
—
|
—
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Ecchymosis, Across doses
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 12 months + 7 daysPopulation: This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in. The data for Dose 3 were not collected from subjects who did not receive the booster dose, given at either Month 6 or Month 12.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature above (\>) 38 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=62 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=66 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=62 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
n=65 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 1
|
13 Participants
|
12 Participants
|
10 Participants
|
21 Participants
|
15 Participants
|
8 Participants
|
9 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 1
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 1
|
13 Participants
|
11 Participants
|
8 Participants
|
19 Participants
|
14 Participants
|
8 Participants
|
6 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 1
|
5 Participants
|
7 Participants
|
8 Participants
|
10 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 2
|
12 Participants
|
20 Participants
|
11 Participants
|
13 Participants
|
14 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 3
|
—
|
—
|
17 Participants
|
16 Participants
|
—
|
—
|
17 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 3
|
—
|
—
|
28 Participants
|
27 Participants
|
—
|
—
|
24 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 3
|
—
|
—
|
1 Participants
|
4 Participants
|
—
|
—
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Across doses
|
17 Participants
|
25 Participants
|
27 Participants
|
28 Participants
|
20 Participants
|
13 Participants
|
29 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Across doses
|
16 Participants
|
22 Participants
|
26 Participants
|
25 Participants
|
20 Participants
|
12 Participants
|
25 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across doses
|
33 Participants
|
34 Participants
|
42 Participants
|
38 Participants
|
36 Participants
|
31 Participants
|
40 Participants
|
42 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across doses
|
34 Participants
|
31 Participants
|
41 Participants
|
41 Participants
|
31 Participants
|
34 Participants
|
45 Participants
|
41 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across doses
|
31 Participants
|
28 Participants
|
36 Participants
|
38 Participants
|
30 Participants
|
30 Participants
|
41 Participants
|
35 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Across doses
|
41 Participants
|
41 Participants
|
47 Participants
|
48 Participants
|
49 Participants
|
41 Participants
|
45 Participants
|
47 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Across doses
|
5 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Across doses
|
39 Participants
|
38 Participants
|
46 Participants
|
47 Participants
|
45 Participants
|
39 Participants
|
43 Participants
|
43 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Across doses
|
6 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Across doses
|
21 Participants
|
26 Participants
|
21 Participants
|
34 Participants
|
22 Participants
|
19 Participants
|
23 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Across doses
|
15 Participants
|
18 Participants
|
23 Participants
|
20 Participants
|
16 Participants
|
7 Participants
|
23 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Across doses
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Across doses
|
13 Participants
|
15 Participants
|
21 Participants
|
17 Participants
|
15 Participants
|
6 Participants
|
21 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 2
|
12 Participants
|
16 Participants
|
9 Participants
|
12 Participants
|
14 Participants
|
11 Participants
|
13 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 1
|
8 Participants
|
12 Participants
|
11 Participants
|
15 Participants
|
13 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 1
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 1
|
7 Participants
|
12 Participants
|
9 Participants
|
12 Participants
|
13 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
25 Participants
|
27 Participants
|
24 Participants
|
26 Participants
|
27 Participants
|
21 Participants
|
25 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
24 Participants
|
25 Participants
|
20 Participants
|
20 Participants
|
27 Participants
|
19 Participants
|
19 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
22 Participants
|
18 Participants
|
19 Participants
|
25 Participants
|
18 Participants
|
24 Participants
|
28 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
21 Participants
|
15 Participants
|
18 Participants
|
21 Participants
|
17 Participants
|
21 Participants
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
29 Participants
|
29 Participants
|
31 Participants
|
32 Participants
|
31 Participants
|
29 Participants
|
27 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
29 Participants
|
26 Participants
|
29 Participants
|
30 Participants
|
30 Participants
|
27 Participants
|
26 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 1
|
6 Participants
|
7 Participants
|
9 Participants
|
12 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 2
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
23 Participants
|
27 Participants
|
28 Participants
|
21 Participants
|
30 Participants
|
22 Participants
|
21 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
20 Participants
|
24 Participants
|
25 Participants
|
19 Participants
|
28 Participants
|
22 Participants
|
18 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
22 Participants
|
22 Participants
|
24 Participants
|
26 Participants
|
24 Participants
|
22 Participants
|
20 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
18 Participants
|
19 Participants
|
18 Participants
|
22 Participants
|
23 Participants
|
20 Participants
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
28 Participants
|
32 Participants
|
27 Participants
|
22 Participants
|
40 Participants
|
30 Participants
|
29 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
25 Participants
|
27 Participants
|
23 Participants
|
21 Participants
|
37 Participants
|
26 Participants
|
28 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 2
|
14 Participants
|
21 Participants
|
10 Participants
|
13 Participants
|
17 Participants
|
14 Participants
|
9 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 2
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 2
|
12 Participants
|
19 Participants
|
9 Participants
|
13 Participants
|
17 Participants
|
14 Participants
|
8 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 2
|
10 Participants
|
12 Participants
|
12 Participants
|
5 Participants
|
13 Participants
|
6 Participants
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 2
|
8 Participants
|
9 Participants
|
12 Participants
|
4 Participants
|
12 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 3
|
—
|
—
|
18 Participants
|
19 Participants
|
—
|
—
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 3
|
—
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 3
|
—
|
—
|
32 Participants
|
30 Participants
|
—
|
—
|
29 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 3
|
—
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 3
|
—
|
—
|
3 Participants
|
3 Participants
|
—
|
—
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 3
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 3
|
—
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 3
|
—
|
—
|
30 Participants
|
28 Participants
|
—
|
—
|
23 Participants
|
32 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 3
|
—
|
—
|
22 Participants
|
26 Participants
|
—
|
—
|
20 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 3
|
—
|
—
|
35 Participants
|
36 Participants
|
—
|
—
|
31 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 3
|
—
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 3
|
—
|
—
|
31 Participants
|
33 Participants
|
—
|
—
|
28 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 3
|
—
|
—
|
17 Participants
|
19 Participants
|
—
|
—
|
18 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 3
|
—
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 3
|
—
|
—
|
15 Participants
|
17 Participants
|
—
|
—
|
17 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 3
|
—
|
—
|
13 Participants
|
13 Participants
|
—
|
—
|
11 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 3
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 3
|
—
|
—
|
11 Participants
|
12 Participants
|
—
|
—
|
10 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Across doses
|
22 Participants
|
28 Participants
|
24 Participants
|
36 Participants
|
22 Participants
|
19 Participants
|
25 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Across doses
|
3 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across doses
|
35 Participants
|
37 Participants
|
45 Participants
|
44 Participants
|
37 Participants
|
33 Participants
|
47 Participants
|
44 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Across doses
|
6 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Across doses
|
6 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across doses
|
4 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: During the 30-day (Days 0-29) post-primary vaccination period (Month 6 + 30 days)Population: This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available.
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 |
GSK1562902A V/I/6 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=66 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
n=65 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AEs
|
31 Participants
|
19 Participants
|
32 Participants
|
28 Participants
|
18 Participants
|
10 Participants
|
19 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AEs
|
12 Participants
|
11 Participants
|
11 Participants
|
15 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: During the 30-day (Days 0-29) post-booster vaccination period (Month 12 + 30 days)Population: This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available. Data were collected only for subjects who received the Month 12 vaccine dose.
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 |
GSK1562902A V/I/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
n=62 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
n=58 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
n=56 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
—
|
—
|
—
|
—
|
16 Participants
|
10 Participants
|
16 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
—
|
—
|
—
|
—
|
7 Participants
|
4 Participants
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
—
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (Day 0 to Month 18)Population: This analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
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 |
GSK1562902A V/I/6 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=66 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
n=65 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
|
35 Participants
|
23 Participants
|
32 Participants
|
31 Participants
|
27 Participants
|
24 Participants
|
30 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (Day 0 to Month 18)Population: This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=66 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
n=65 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At Month 6 + 7 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=45 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 7 Days
|
47 Participants
|
40 Participants
|
31 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 7 Days
|
48 Participants
|
35 Participants
|
40 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 21 daysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster SCR was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=52 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 21 Days
|
51 Participants
|
39 Participants
|
45 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 21 Days
|
51 Participants
|
42 Participants
|
44 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 7 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean\[log10(POST/M6)\]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=45 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 7 Days
|
27.9 Fold Increase
Interval 20.4 to 38.3
|
12.3 Fold Increase
Interval 7.8 to 19.2
|
14.5 Fold Increase
Interval 8.7 to 24.3
|
9.2 Fold Increase
Interval 6.2 to 13.7
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 7 Days
|
18.2 Fold Increase
Interval 12.8 to 26.0
|
20.3 Fold Increase
Interval 12.7 to 32.5
|
6.3 Fold Increase
Interval 4.1 to 9.7
|
6.9 Fold Increase
Interval 4.5 to 10.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean\[log10(POST/M6)\]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 6.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=52 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease
A/Indonesia, Month 6 + 21 Days
|
55.3 Fold Increase
Interval 39.5 to 77.4
|
17.6 Fold Increase
Interval 11.5 to 26.8
|
45.6 Fold Increase
Interval 30.8 to 67.4
|
17.9 Fold Increase
Interval 11.9 to 27.0
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease
A/Vietnam, Month 6 + 21 Days
|
35.4 Fold Increase
Interval 24.5 to 51.1
|
29.2 Fold Increase
Interval 18.2 to 46.6
|
19.1 Fold Increase
Interval 12.4 to 29.4
|
11.5 Fold Increase
Interval 7.3 to 18.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and at Month 18Population: This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for Month 18), which included all evaluable subjects for whom immunogenicity were available and who complied with the inclusion/exclusion criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=59 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=60 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 6
|
13.2 Titers
Interval 9.3 to 18.7
|
10.6 Titers
Interval 8.0 to 14.0
|
38.4 Titers
Interval 26.6 to 55.5
|
24.0 Titers
Interval 17.2 to 33.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 21
|
22.1 Titers
Interval 14.5 to 33.8
|
17.6 Titers
Interval 12.3 to 25.2
|
21.4 Titers
Interval 14.3 to 32.0
|
15.8 Titers
Interval 10.9 to 23.1
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 42
|
—
|
—
|
239.4 Titers
Interval 157.2 to 364.8
|
178.3 Titers
Interval 116.6 to 272.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 18
|
115.8 Titers
Interval 71.9 to 186.3
|
76.1 Titers
Interval 47.1 to 123.1
|
337.5 Titers
Interval 219.5 to 518.9
|
149.3 Titers
Interval 93.0 to 239.6
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 21
|
6.8 Titers
Interval 5.5 to 8.3
|
6.3 Titers
Interval 5.2 to 7.7
|
6.0 Titers
Interval 5.2 to 6.8
|
5.3 Titers
Interval 5.0 to 5.7
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 42
|
—
|
—
|
28.0 Titers
Interval 18.0 to 43.6
|
18.6 Titers
Interval 12.7 to 27.2
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 6
|
5.7 Titers
Interval 5.1 to 6.4
|
5.4 Titers
Interval 4.8 to 6.0
|
10.2 Titers
Interval 7.8 to 13.3
|
6.5 Titers
Interval 5.6 to 7.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12
|
5.8 Titers
Interval 5.0 to 6.8
|
5.9 Titers
Interval 5.1 to 6.8
|
5.7 Titers
Interval 5.0 to 6.5
|
8.4 Titers
Interval 6.4 to 11.1
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
97.8 Titers
Interval 66.5 to 143.8
|
196.2 Titers
Interval 128.6 to 299.2
|
106.5 Titers
Interval 66.7 to 170.0
|
239.4 Titers
Interval 149.9 to 382.2
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
139.3 Titers
Interval 92.0 to 211.0
|
420.0 Titers
Interval 283.8 to 621.6
|
191.9 Titers
Interval 121.6 to 303.0
|
624.9 Titers
Interval 469.3 to 831.9
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 18
|
139.3 Titers
Interval 85.7 to 226.6
|
56.6 Titers
Interval 35.5 to 90.2
|
385.9 Titers
Interval 252.9 to 588.6
|
121.3 Titers
Interval 76.6 to 192.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.1 Titers
Interval 4.9 to 5.4
|
5.1 Titers
Interval 4.9 to 5.4
|
5.2 Titers
Interval 4.8 to 5.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12
|
8.4 Titers
Interval 6.4 to 11.0
|
9.9 Titers
Interval 7.3 to 13.5
|
14.2 Titers
Interval 10.1 to 20.1
|
17.4 Titers
Interval 11.6 to 25.9
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
235.9 Titers
Interval 153.7 to 362.1
|
354.3 Titers
Interval 244.7 to 513.0
|
257.7 Titers
Interval 162.4 to 409.0
|
358.2 Titers
Interval 228.7 to 561.1
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
352.6 Titers
Interval 229.9 to 540.8
|
662.2 Titers
Interval 458.3 to 956.6
|
441.0 Titers
Interval 279.5 to 695.9
|
942.2 Titers
Interval 703.1 to 1262.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 DaysPopulation: This analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=59 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=60 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 42
|
—
|
—
|
24 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
40 Participants
|
44 Participants
|
34 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 6
|
15 Participants
|
10 Participants
|
35 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 21
|
5 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 6
|
0 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12
|
6 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
42 Participants
|
49 Participants
|
36 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 21
|
26 Participants
|
24 Participants
|
25 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 42
|
—
|
—
|
44 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12
|
6 Participants
|
10 Participants
|
9 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
45 Participants
|
49 Participants
|
37 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
46 Participants
|
50 Participants
|
38 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 12 + 7 Days, Month 12 + 21 Days and Month 18Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Persistence, which included all evaluable subjects for whom ilong term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=40 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=40 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
46 Participants
|
39 Participants
|
40 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
43 Participants
|
41 Participants
|
35 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
40 Participants
|
37 Participants
|
36 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 18
|
39 Participants
|
34 Participants
|
37 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
47 Participants
|
42 Participants
|
40 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 18
|
30 Participants
|
33 Participants
|
34 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
The seroconversion factor (SCF) was defined as the fold change in serum hemagglutination inhibition (HI) geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=59 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=57 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=52 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=51 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Month 6
|
1.1 Fold Increase
Interval 1.0 to 1.3
|
1.1 Fold Increase
Interval 1.0 to 1.2
|
2.0 Fold Increase
Interval 1.6 to 2.7
|
1.3 Fold Increase
Interval 1.1 to 1.5
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Month 12
|
2.0 Fold Increase
Interval 1.5 to 2.7
|
1.6 Fold Increase
Interval 1.3 to 2.1
|
3.5 Fold Increase
Interval 2.3 to 5.2
|
2.7 Fold Increase
Interval 1.9 to 3.9
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
70.9 Fold Increase
Interval 48.9 to 102.6
|
45.9 Fold Increase
Interval 29.8 to 70.7
|
71.6 Fold Increase
Interval 45.7 to 112.2
|
49.4 Fold Increase
Interval 31.0 to 78.6
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
132.4 Fold Increase
Interval 91.7 to 191.3
|
68.6 Fold Increase
Interval 44.5 to 105.8
|
188.4 Fold Increase
Interval 140.6 to 252.5
|
84.5 Fold Increase
Interval 53.3 to 133.9
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Day 21
|
1.4 Fold Increase
Interval 1.1 to 1.7
|
1.3 Fold Increase
Interval 1.0 to 1.6
|
1.2 Fold Increase
Interval 1.0 to 1.3
|
1.1 Fold Increase
Interval 1.0 to 1.2
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Day 42
|
—
|
—
|
5.9 Fold Increase
Interval 3.6 to 9.5
|
3.6 Fold Increase
Interval 2.5 to 5.3
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Month 12
|
1.2 Fold Increase
Interval 1.0 to 1.2
|
1.2 Fold Increase
Interval 1.0 to 1.2
|
1.7 Fold Increase
Interval 1.3 to 2.2
|
1.1 Fold Increase
Interval 1.0 to 1.3
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
39.2 Fold Increase
Interval 25.7 to 59.8
|
19.6 Fold Increase
Interval 13.3 to 28.8
|
47.9 Fold Increase
Interval 30.0 to 76.4
|
21.3 Fold Increase
Interval 13.3 to 34.0
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
84.0 Fold Increase
Interval 56.8 to 124.3
|
27.9 Fold Increase
Interval 18.4 to 42.2
|
125.0 Fold Increase
Interval 93.9 to 166.4
|
38.4 Fold Increase
Interval 24.3 to 60.6
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Day 21
|
4.1 Fold Increase
Interval 2.6 to 6.3
|
3.6 Fold Increase
Interval 2.5 to 5.2
|
3.8 Fold Increase
Interval 2.5 to 5.6
|
3.2 Fold Increase
Interval 2.2 to 4.8
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Day 42
|
—
|
—
|
45.6 Fold Increase
Interval 28.4 to 73.4
|
34.4 Fold Increase
Interval 22.7 to 52.2
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Month 6
|
2.6 Fold Increase
Interval 1.9 to 3.7
|
2.1 Fold Increase
Interval 1.6 to 2.7
|
7.5 Fold Increase
Interval 5.2 to 10.8
|
4.6 Fold Increase
Interval 3.4 to 6.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=59 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=60 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Day 42
|
—
|
—
|
24 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Month 12
|
2 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
40 Participants
|
44 Participants
|
34 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
42 Participants
|
49 Participants
|
36 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Day 21
|
26 Participants
|
24 Participants
|
25 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Day 42
|
—
|
—
|
45 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Month 6
|
15 Participants
|
10 Participants
|
36 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Month 12
|
6 Participants
|
10 Participants
|
9 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Month 12 + 7 days
|
45 Participants
|
49 Participants
|
37 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
46 Participants
|
50 Participants
|
38 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Day 21
|
5 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12
A/Indonesia, Month 6
|
0 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and at Month 18Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=51 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=44 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 21
|
6.5 Titers
Interval 5.4 to 7.7
|
5.6 Titers
Interval 5.1 to 6.0
|
6.3 Titers
Interval 5.2 to 7.6
|
5.4 Titers
Interval 5.0 to 5.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 42
|
—
|
—
|
22.5 Titers
Interval 14.8 to 34.3
|
16.7 Titers
Interval 10.8 to 25.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6
|
5.5 Titers
Interval 5.0 to 6.1
|
5.3 Titers
Interval 4.9 to 5.7
|
8.5 Titers
Interval 6.4 to 11.2
|
7.0 Titers
Interval 5.8 to 8.4
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 7 Days
|
142.6 Titers
Interval 102.7 to 197.9
|
64.5 Titers
Interval 40.1 to 103.7
|
124.1 Titers
Interval 75.2 to 204.8
|
59.9 Titers
Interval 38.1 to 94.3
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 21 Days
|
290.8 Titers
Interval 202.1 to 418.3
|
97.9 Titers
Interval 63.3 to 151.2
|
383.5 Titers
Interval 245.2 to 599.7
|
120.9 Titers
Interval 76.9 to 190.1
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 12
|
44.6 Titers
Interval 28.6 to 69.5
|
17.6 Titers
Interval 11.8 to 26.2
|
56.6 Titers
Interval 33.7 to 95.0
|
23.8 Titers
Interval 14.5 to 38.9
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 18
|
31.1 Titers
Interval 20.3 to 47.5
|
19.8 Titers
Interval 13.3 to 29.7
|
50.6 Titers
Interval 32.0 to 79.9
|
28.3 Titers
Interval 17.0 to 47.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.2 Titers
Interval 5.2 to 5.6
|
5.2 Titers
Interval 4.8 to 5.7
|
5.8 Titers
Interval 4.7 to 7.2
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 21
|
20.7 Titers
Interval 13.9 to 30.7
|
15.8 Titers
Interval 10.9 to 23.0
|
34.3 Titers
Interval 21.4 to 55.0
|
30.8 Titers
Interval 18.2 to 52.2
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 42
|
—
|
—
|
220.6 Titers
Interval 145.4 to 334.6
|
275.1 Titers
Interval 178.2 to 424.7
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6
|
11.6 Titers
Interval 8.6 to 15.5
|
9.7 Titers
Interval 7.3 to 12.9
|
29.6 Titers
Interval 19.7 to 44.4
|
31.3 Titers
Interval 20.2 to 48.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 7 Days
|
209.0 Titers
Interval 152.7 to 286.2
|
215.4 Titers
Interval 137.8 to 336.6
|
191.0 Titers
Interval 117.3 to 311.0
|
211.7 Titers
Interval 133.0 to 337.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 21 Days
|
411.1 Titers
Interval 291.3 to 580.3
|
317.4 Titers
Interval 197.5 to 510.1
|
542.1 Titers
Interval 340.8 to 862.5
|
359.2 Titers
Interval 220.2 to 585.9
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 18
|
24.3 Titers
Interval 16.3 to 36.4
|
25.7 Titers
Interval 16.3 to 40.4
|
45.1 Titers
Interval 28.8 to 70.7
|
46.4 Titers
Interval 27.7 to 77.7
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 12
|
66.0 Titers
Interval 43.0 to 101.1
|
63.8 Titers
Interval 40.6 to 100.3
|
107.1 Titers
Interval 66.4 to 172.8
|
101.6 Titers
Interval 62.4 to 165.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18Population: This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M6+D7/D21, M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=50 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 21
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 42
|
—
|
—
|
15 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 7 Days
|
43 Participants
|
31 Participants
|
38 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 21 Days
|
46 Participants
|
35 Participants
|
42 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 12
|
16 Participants
|
29 Participants
|
19 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 18
|
26 Participants
|
18 Participants
|
28 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 21
|
19 Participants
|
24 Participants
|
23 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6
|
5 Participants
|
13 Participants
|
25 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 7 Days
|
43 Participants
|
36 Participants
|
29 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 42
|
—
|
—
|
36 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 21 Days
|
46 Participants
|
38 Participants
|
41 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 12
|
33 Participants
|
35 Participants
|
32 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 18
|
11 Participants
|
15 Participants
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18Population: This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M6+D7/D21, M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
The seroconversion factor (SCF) was defined as the fold change in serum hemagglutination inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=66 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=63 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=61 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=64 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Indonesia, Month 6 + 7 Days
|
25.8 Fold Increase
Interval 18.5 to 36.0
|
12.2 Fold Increase
Interval 7.6 to 19.6
|
14.9 Fold Increase
Interval 8.6 to 26.0
|
8.6 Fold Increase
Interval 5.6 to 13.2
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Indonesia, Month 6
|
1.0 Fold Increase
Interval 1.0 to 1.1
|
1.1 Fold Increase
Interval 1.0 to 1.3
|
1.6 Fold Increase
Interval 1.4 to 2.0
|
1.6 Fold Increase
Interval 1.3 to 2.0
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Indonesia, Day 21
|
1.1 Fold Increase
Interval 1.0 to 1.2
|
1.3 Fold Increase
Interval 1.1 to 1.5
|
1.1 Fold Increase
Interval 1.0 to 1.3
|
1.2 Fold Increase
Interval 1.0 to 1.4
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Indonesia, Day 42
|
—
|
—
|
4.1 Fold Increase
Interval 2.8 to 6.0
|
4.6 Fold Increase
Interval 3.2 to 6.8
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Indonesia, Month 6 + 21 Days
|
52.5 Fold Increase
Interval 36.7 to 75.0
|
18.5 Fold Increase
Interval 11.9 to 28.8
|
45.3 Fold Increase
Interval 29.9 to 68.5
|
17.5 Fold Increase
Interval 11.2 to 27.4
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Indonesia, Month 12
|
2.9 Fold Increase
Interval 2.1 to 4.0
|
8.9 Fold Increase
Interval 5.8 to 13.6
|
5.5 Fold Increase
Interval 3.7 to 8.3
|
11.6 Fold Increase
Interval 7.4 to 18.2
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Indonesia, Month 18
|
5.7 Fold Increase
Interval 3.7 to 8.5
|
3.7 Fold Increase
Interval 2.5 to 5.7
|
6.0 Fold Increase
Interval 4.0 to 9.0
|
4.3 Fold Increase
Interval 2.7 to 6.7
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Vietnam, Day 21
|
3.0 Fold Increase
Interval 2.2 to 4.0
|
4.0 Fold Increase
Interval 2.8 to 5.8
|
5.7 Fold Increase
Interval 3.8 to 8.5
|
5.4 Fold Increase
Interval 3.8 to 7.9
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Vietnam, Day 42
|
—
|
—
|
50.3 Fold Increase
Interval 34.8 to 72.7
|
40.8 Fold Increase
Interval 27.5 to 60.5
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Vietnam, Month 6
|
1.7 Fold Increase
Interval 1.4 to 2.1
|
2.4 Fold Increase
Interval 1.8 to 3.2
|
6.4 Fold Increase
Interval 4.5 to 8.9
|
6.0 Fold Increase
Interval 4.3 to 8.5
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Vietnam, Month 6 + 7 Days
|
17.5 Fold Increase
Interval 12.1 to 25.1
|
21.6 Fold Increase
Interval 13.1 to 35.5
|
6.5 Fold Increase
Interval 4.1 to 10.4
|
6.6 Fold Increase
Interval 4.1 to 10.6
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Vietnam, Month 6 + 21 Days
|
34.7 Fold Increase
Interval 23.9 to 50.5
|
32.3 Fold Increase
Interval 19.8 to 52.7
|
18.3 Fold Increase
Interval 11.6 to 28.9
|
11.0 Fold Increase
Interval 6.8 to 17.9
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Vietnam, Month 12
|
9.6 Fold Increase
Interval 6.3 to 14.7
|
14.3 Fold Increase
Interval 9.6 to 21.4
|
19.0 Fold Increase
Interval 12.9 to 28.1
|
22.5 Fold Increase
Interval 14.5 to 34.9
|
—
|
—
|
—
|
—
|
|
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6
A/Vietnam, Month 18
|
2.1 Fold Increase
Interval 1.5 to 3.1
|
2.7 Fold Increase
Interval 1.7 to 4.2
|
1.5 Fold Increase
Interval 1.1 to 2.2
|
1.5 Fold Increase
Interval 0.9 to 2.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and Month 18Population: This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
A seroprotected (SPR) subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=50 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 21
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 42
|
—
|
—
|
15 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 7 Days
|
32 Participants
|
46 Participants
|
31 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 21 Days
|
37 Participants
|
48 Participants
|
37 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 12
|
16 Participants
|
29 Participants
|
19 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 18
|
26 Participants
|
18 Participants
|
30 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 0
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 21
|
19 Participants
|
24 Participants
|
24 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 42
|
—
|
—
|
36 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6
|
6 Participants
|
13 Participants
|
26 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 7 Days
|
39 Participants
|
49 Participants
|
38 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 21 Days
|
40 Participants
|
48 Participants
|
39 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 12
|
33 Participants
|
35 Participants
|
33 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 18
|
21 Participants
|
24 Participants
|
30 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 12 + 7 Days, Month 12 + 21 Days and Month 18Population: This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M18), which included all evaluable subjects for whom immunogenicity data/long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=50 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=51 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=40 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=43 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 18
|
39 Participants
|
34 Participants
|
37 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
41 Participants
|
49 Participants
|
36 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
38 Participants
|
43 Participants
|
34 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
43 Participants
|
46 Participants
|
34 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
44 Participants
|
50 Participants
|
37 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 18
|
30 Participants
|
33 Participants
|
34 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 12 + 7 Days and at Month 12 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean\[log10(POST/M12)\]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 12.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=51 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=50 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=43 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=40 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
33.1 Fold Increase
Interval 21.3 to 51.6
|
16.7 Fold Increase
Interval 11.3 to 24.7
|
29.1 Fold Increase
Interval 17.0 to 49.6
|
18.7 Fold Increase
Interval 11.7 to 29.9
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
70.9 Fold Increase
Interval 47.0 to 107.0
|
23.8 Fold Increase
Interval 15.7 to 35.9
|
75.8 Fold Increase
Interval 54.2 to 106.1
|
33.7 Fold Increase
Interval 21.0 to 54.1
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
35.2 Fold Increase
Interval 22.4 to 55.3
|
27.5 Fold Increase
Interval 17.4 to 43.5
|
21.9 Fold Increase
Interval 12.7 to 37.9
|
17.6 Fold Increase
Interval 10.8 to 28.8
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
65.8 Fold Increase
Interval 42.2 to 102.6
|
41.1 Fold Increase
Interval 25.8 to 65.4
|
57.6 Fold Increase
Interval 38.6 to 86.1
|
30.2 Fold Increase
Interval 18.6 to 48.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 12 + 7 Days, Month 12 + 21 Days and at Month 18Population: The analysis was performed on the ATP Cohort for persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean\[log10(POST/M12)\]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 12.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=40 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=40 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
35.2 Fold Increase
Interval 22.4 to 55.4
|
16.8 Fold Increase
Interval 11.2 to 25.2
|
27.9 Fold Increase
Interval 15.8 to 49.2
|
18.7 Fold Increase
Interval 11.7 to 29.9
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
78.7 Fold Increase
Interval 52.9 to 117.2
|
23.6 Fold Increase
Interval 15.4 to 36.3
|
76.2 Fold Increase
Interval 53.2 to 109.0
|
33.7 Fold Increase
Interval 21.0 to 54.1
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 18
|
25.1 Fold Increase
Interval 15.8 to 39.8
|
10.3 Fold Increase
Interval 6.6 to 16.0
|
44.5 Fold Increase
Interval 27.9 to 71.0
|
21.3 Fold Increase
Interval 13.2 to 34.4
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 18
|
12.0 Fold Increase
Interval 7.3 to 19.8
|
10.2 Fold Increase
Interval 6.4 to 16.1
|
18.6 Fold Increase
Interval 11.1 to 31.2
|
10.2 Fold Increase
Interval 6.2 to 16.8
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
37.9 Fold Increase
Interval 24.0 to 59.8
|
28.9 Fold Increase
Interval 18.1 to 46.3
|
19.9 Fold Increase
Interval 11.2 to 35.3
|
17.6 Fold Increase
Interval 10.8 to 28.8
|
—
|
—
|
—
|
—
|
|
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
73.6 Fold Increase
Interval 47.9 to 113.3
|
43.1 Fold Increase
Interval 26.6 to 69.6
|
55.7 Fold Increase
Interval 36.4 to 85.3
|
30.2 Fold Increase
Interval 18.6 to 48.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18Population: This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M12, M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 All Doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The 2 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=41 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=42 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=36 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=35 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 All Doubles - A/Vietnam, Month 12
|
1316.68 cells/million T-cells
Standard Deviation 1359.39
|
1431.92 cells/million T-cells
Standard Deviation 1291.80
|
1506.94 cells/million T-cells
Standard Deviation 1086.61
|
1220.87 cells/million T-cells
Standard Deviation 2280.45
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 TNF-α - A/Vietnam, Month 6 + 7 Days
|
17.12 cells/million T-cells
Standard Deviation 200.81
|
14.74 cells/million T-cells
Standard Deviation 90.05
|
25.85 cells/million T-cells
Standard Deviation 186.72
|
27.99 cells/million T-cells
Standard Deviation 151.32
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 TNF-α - A/Vietnam, Month 6 + 21 Days
|
28.56 cells/million T-cells
Standard Deviation 229.92
|
38.71 cells/million T-cells
Standard Deviation 137.20
|
27.86 cells/million T-cells
Standard Deviation 156.35
|
11.99 cells/million T-cells
Standard Deviation 83.27
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 All Doubles - A/Vietnam, Month 6
|
600.07 cells/million T-cells
Standard Deviation 901.78
|
807.14 cells/million T-cells
Standard Deviation 806.63
|
896.67 cells/million T-cells
Standard Deviation 627.38
|
1071.19 cells/million T-cells
Standard Deviation 923.45
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 All Doubles - A/Vietnam, Month 6 + 21 Days
|
1619.46 cells/million T-cells
Standard Deviation 1899.48
|
1531.69 cells/million T-cells
Standard Deviation 1741.38
|
1489.30 cells/million T-cells
Standard Deviation 1564.28
|
1953.30 cells/million T-cells
Standard Deviation 2219.16
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 All Doubles - A/Indonesia, Month 12
|
1196.05 cells/million T-cells
Standard Deviation 1279.60
|
1461.46 cells/million T-cells
Standard Deviation 1972.69
|
1512.82 cells/million T-cells
Standard Deviation 996.79
|
1243.41 cells/million T-cells
Standard Deviation 1434.39
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 All Doubles - A/Indonesia, Month 18
|
1192.82 cells/million T-cells
Standard Deviation 1000.13
|
1767.82 cells/million T-cells
Standard Deviation 1194.85
|
1978.73 cells/million T-cells
Standard Deviation 1138.17
|
1550.40 cells/million T-cells
Standard Deviation 1557.30
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 All Doubles - A/Vietnam, Month 18
|
1194.69 cells/million T-cells
Standard Deviation 1073.65
|
1790.56 cells/million T-cells
Standard Deviation 1178.39
|
1676.20 cells/million T-cells
Standard Deviation 1267.85
|
1560.54 cells/million T-cells
Standard Deviation 1546.70
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 CD40L - A/Vietnam, Day 0
|
350.86 cells/million T-cells
Standard Deviation 455.52
|
446.27 cells/million T-cells
Standard Deviation 318.18
|
387.68 cells/million T-cells
Standard Deviation 458.40
|
441.16 cells/million T-cells
Standard Deviation 460.09
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 CD40L - A/Vietnam, Month 6
|
593.74 cells/million T-cells
Standard Deviation 885.01
|
809.47 cells/million T-cells
Standard Deviation 777.20
|
867.92 cells/million T-cells
Standard Deviation 591.04
|
1046.99 cells/million T-cells
Standard Deviation 893.54
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 CD40L- A/Vietnam, Month 18
|
1162.79 cells/million T-cells
Standard Deviation 1043.15
|
1738.30 cells/million T-cells
Standard Deviation 1140.59
|
1640.12 cells/million T-cells
Standard Deviation 1252.01
|
1518.75 cells/million T-cells
Standard Deviation 1489.22
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IL-2 - A/Vietnam, Day 0
|
262.64 cells/million T-cells
Standard Deviation 339.55
|
264.51 cells/million T-cells
Standard Deviation 249.40
|
230.40 cells/million T-cells
Standard Deviation 360.46
|
289.83 cells/million T-cells
Standard Deviation 385.44
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IL-2 - A/Vietnam, Month 6
|
450.20 cells/million T-cells
Standard Deviation 815.29
|
601.02 cells/million T-cells
Standard Deviation 736.05
|
648.07 cells/million T-cells
Standard Deviation 584.83
|
719.07 cells/million T-cells
Standard Deviation 763.89
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IL-2 - A/Vietnam, Month 6 + 7 Days
|
861.32 cells/million T-cells
Standard Deviation 1997.52
|
890.90 cells/million T-cells
Standard Deviation 1030.87
|
1390.30 cells/million T-cells
Standard Deviation 1480.20
|
1147.31 cells/million T-cells
Standard Deviation 980.42
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IL-2 - A/Vietnam, Month 6 + 21 Days
|
1238.06 cells/million T-cells
Standard Deviation 1759.16
|
1036.73 cells/million T-cells
Standard Deviation 1545.30
|
965.41 cells/million T-cells
Standard Deviation 1302.89
|
1380.65 cells/million T-cells
Standard Deviation 1761.07
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IL-2 - A/Vietnam, Month 12
|
1119.56 cells/million T-cells
Standard Deviation 1261.18
|
1160.06 cells/million T-cells
Standard Deviation 1049.95
|
1264.64 cells/million T-cells
Standard Deviation 1008.46
|
999.23 cells/million T-cells
Standard Deviation 2005.29
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IFN-γ - A/Vietnam, Month 6 + 7 Days
|
632.73 cells/million T-cells
Standard Deviation 848.00
|
683.35 cells/million T-cells
Standard Deviation 702.66
|
826.27 cells/million T-cells
Standard Deviation 856.63
|
887.74 cells/million T-cells
Standard Deviation 412.30
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IFN-γ - A/Indonesia, Month 12
|
615.47 cells/million T-cells
Standard Deviation 624.58
|
829.05 cells/million T-cells
Standard Deviation 903.32
|
752.50 cells/million T-cells
Standard Deviation 525.81
|
746.33 cells/million T-cells
Standard Deviation 727.94
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 TNF-α - A/Indonesia, Month 12
|
914.94 cells/million T-cells
Standard Deviation 1053.34
|
1125.16 cells/million T-cells
Standard Deviation 1559.54
|
1235.28 cells/million T-cells
Standard Deviation 813.44
|
1148.53 cells/million T-cells
Standard Deviation 1208.96
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 TNF-α - A/Vietnam, Month 12
|
970.90 cells/million T-cells
Standard Deviation 1091.23
|
1047.93 cells/million T-cells
Standard Deviation 978.11
|
1238.05 cells/million T-cells
Standard Deviation 858.40
|
1096.87 cells/million T-cells
Standard Deviation 1906.75
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 TNF-α - A/Indonesia, Month 18
|
922.42 cells/million T-cells
Standard Deviation 794.83
|
1318.59 cells/million T-cells
Standard Deviation 923.86
|
1647.61 cells/million T-cells
Standard Deviation 927.11
|
1224.50 cells/million T-cells
Standard Deviation 1267.20
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 All Doubles - A/Vietnam, Month 18
|
33.20 cells/million T-cells
Standard Deviation 623.81
|
12.14 cells/million T-cells
Standard Deviation 907.62
|
29.83 cells/million T-cells
Standard Deviation 673.80
|
11.17 cells/million T-cells
Standard Deviation 676.65
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 CD40L - A/Vietnam, Day 0
|
7.17 cells/million T-cells
Standard Deviation 84.29
|
4.74 cells/million T-cells
Standard Deviation 71.68
|
5.49 cells/million T-cells
Standard Deviation 39.03
|
6.15 cells/million T-cells
Standard Deviation 165.75
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 CD40L - A/Vietnam, Month 6
|
3.12 cells/million T-cells
Standard Deviation 35.61
|
7.18 cells/million T-cells
Standard Deviation 39.67
|
5.01 cells/million T-cells
Standard Deviation 69.22
|
4.81 cells/million T-cells
Standard Deviation 49.19
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 CD40L - A/Vietnam, Month 6 + 21 Days
|
2.11 cells/million T-cells
Standard Deviation 22.77
|
4.88 cells/million T-cells
Standard Deviation 37.26
|
3.78 cells/million T-cells
Standard Deviation 33.23
|
3.21 cells/million T-cells
Standard Deviation 30.61
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 CD40L - A/Vietnam, Month 18
|
5.71 cells/million T-cells
Standard Deviation 53.55
|
2.75 cells/million T-cells
Standard Deviation 96.74
|
4.14 cells/million T-cells
Standard Deviation 95.17
|
3.07 cells/million T-cells
Standard Deviation 40.00
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IL-2 - A/Vietnam, Day 0
|
36.92 cells/million T-cells
Standard Deviation 229.00
|
14.67 cells/million T-cells
Standard Deviation 100.62
|
16.98 cells/million T-cells
Standard Deviation 130.69
|
27.00 cells/million T-cells
Standard Deviation 258.14
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IL-2 - A/Vietnam, Month 6
|
12.84 cells/million T-cells
Standard Deviation 129.21
|
12.58 cells/million T-cells
Standard Deviation 239.74
|
22.68 cells/million T-cells
Standard Deviation 113.81
|
25.91 cells/million T-cells
Standard Deviation 102.37
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IL-2 - A/Vietnam, Month 6 + 7 Days
|
16.03 cells/million T-cells
Standard Deviation 218.16
|
17.04 cells/million T-cells
Standard Deviation 92.98
|
32.94 cells/million T-cells
Standard Deviation 154.53
|
26.46 cells/million T-cells
Standard Deviation 113.81
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IL-2 - A/Vietnam, Month 6 + 21 Days
|
31.00 cells/million T-cells
Standard Deviation 185.96
|
28.04 cells/million T-cells
Standard Deviation 156.16
|
22.75 cells/million T-cells
Standard Deviation 138.13
|
13.48 cells/million T-cells
Standard Deviation 93.72
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IL-2 - A/Indonesia, Month 12
|
40.26 cells/million T-cells
Standard Deviation 1211.36
|
27.79 cells/million T-cells
Standard Deviation 1135.75
|
48.91 cells/million T-cells
Standard Deviation 1897.48
|
28.61 cells/million T-cells
Standard Deviation 1566.57
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IL-2 - A/Vietnam, Month 18
|
32.16 cells/million T-cells
Standard Deviation 615.73
|
11.75 cells/million T-cells
Standard Deviation 902.78
|
26.63 cells/million T-cells
Standard Deviation 674.63
|
9.50 cells/million T-cells
Standard Deviation 678.33
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IFN-γ - A/Vietnam, Day 0
|
29.70 cells/million T-cells
Standard Deviation 347.16
|
14.50 cells/million T-cells
Standard Deviation 125.14
|
24.17 cells/million T-cells
Standard Deviation 183.45
|
23.68 cells/million T-cells
Standard Deviation 347.01
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IFN-γ - A/Vietnam, Month 6
|
9.15 cells/million T-cells
Standard Deviation 195.76
|
15.10 cells/million T-cells
Standard Deviation 164.89
|
25.09 cells/million T-cells
Standard Deviation 269.60
|
10.92 cells/million T-cells
Standard Deviation 133.43
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IFN-γ - A/Vietnam, Month 6 + 7 days
|
17.52 cells/million T-cells
Standard Deviation 252.30
|
6.54 cells/million T-cells
Standard Deviation 65.11
|
6.15 cells/million T-cells
Standard Deviation 190.69
|
12.90 cells/million T-cells
Standard Deviation 96.83
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IFN-γ - A/Vietnam, Month 12
|
4.44 cells/million T-cells
Standard Deviation 305.15
|
4.24 cells/million T-cells
Standard Deviation 133.39
|
10.21 cells/million T-cells
Standard Deviation 83.42
|
4.42 cells/million T-cells
Standard Deviation 56.81
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IFN-γ - A/Indonesia, Month 18
|
4.74 cells/million T-cells
Standard Deviation 91.61
|
4.33 cells/million T-cells
Standard Deviation 111.98
|
4.61 cells/million T-cells
Standard Deviation 83.81
|
3.73 cells/million T-cells
Standard Deviation 97.93
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 TNF-α - A/Vietnam, Day 0
|
25.46 cells/million T-cells
Standard Deviation 308.45
|
14.67 cells/million T-cells
Standard Deviation 92.23
|
22.21 cells/million T-cells
Standard Deviation 183.41
|
35.35 cells/million T-cells
Standard Deviation 219.77
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 All Doubles - A/Vietnam, Day 0
|
412.03 cells/million T-cells
Standard Deviation 487.53
|
467.30 cells/million T-cells
Standard Deviation 333.87
|
395.60 cells/million T-cells
Standard Deviation 477.64
|
469.25 cells/million T-cells
Standard Deviation 470.89
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 All Doubles - A/Vietnam, Month 6 + 7 Days
|
1120.95 cells/million T-cells
Standard Deviation 2182.54
|
1369.15 cells/million T-cells
Standard Deviation 1224.75
|
1914.50 cells/million T-cells
Standard Deviation 1757.90
|
1769.33 cells/million T-cells
Standard Deviation 1024.50
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 CD40L - A/Vietnam, Month 6 + 7 Days
|
1084.46 cells/million T-cells
Standard Deviation 2123.12
|
1298.95 cells/million T-cells
Standard Deviation 1153.28
|
1818.39 cells/million T-cells
Standard Deviation 1603.64
|
1717.69 cells/million T-cells
Standard Deviation 990.51
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 CD40L - A/Vietnam, Month 6 + 21 Days
|
1588.60 cells/million T-cells
Standard Deviation 1855.12
|
1487.73 cells/million T-cells
Standard Deviation 1663.98
|
1480.21 cells/million T-cells
Standard Deviation 1520.92
|
1880.07 cells/million T-cells
Standard Deviation 2151.87
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 CD40L - A/Indonesia, Month 12
|
1183.85 cells/million T-cells
Standard Deviation 1255.59
|
1448.44 cells/million T-cells
Standard Deviation 1973.98
|
1505.73 cells/million T-cells
Standard Deviation 985.99
|
1221.20 cells/million T-cells
Standard Deviation 1371.18
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 CD40L - A/Vietnam, Month 12
|
1238.24 cells/million T-cells
Standard Deviation 1362.58
|
1390.02 cells/million T-cells
Standard Deviation 1288.92
|
1474.26 cells/million T-cells
Standard Deviation 1073.10
|
1152.29 cells/million T-cells
Standard Deviation 2263.92
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 CD40L - A/Indonesia, Month 18
|
1172.36 cells/million T-cells
Standard Deviation 985.13
|
1747.96 cells/million T-cells
Standard Deviation 1151.98
|
1975.69 cells/million T-cells
Standard Deviation 1126.07
|
1522.12 cells/million T-cells
Standard Deviation 1553.48
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IL-2 - A/Indonesia, Month 12
|
1001.88 cells/million T-cells
Standard Deviation 1156.16
|
1169.25 cells/million T-cells
Standard Deviation 1630.99
|
1278.49 cells/million T-cells
Standard Deviation 908.04
|
1041.21 cells/million T-cells
Standard Deviation 1250.37
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IL-2 - A/Indonesia, Month 18
|
999.22 cells/million T-cells
Standard Deviation 844.48
|
1412.43 cells/million T-cells
Standard Deviation 986.25
|
1480.68 cells/million T-cells
Standard Deviation 1040.08
|
1248.66 cells/million T-cells
Standard Deviation 1383.46
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IL-2- A/Vietnam, Month 18
|
1011.14 cells/million T-cells
Standard Deviation 921.27
|
1487.16 cells/million T-cells
Standard Deviation 1006.20
|
1434.59 cells/million T-cells
Standard Deviation 1156.89
|
1140.29 cells/million T-cells
Standard Deviation 1374.45
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IFN-γ - A/Vietnam, Day 0
|
303.97 cells/million T-cells
Standard Deviation 403.90
|
267.88 cells/million T-cells
Standard Deviation 316.20
|
275.09 cells/million T-cells
Standard Deviation 299.79
|
331.35 cells/million T-cells
Standard Deviation 379.46
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IFN-γ - A/Vietnam, Month 6
|
309.94 cells/million T-cells
Standard Deviation 596.66
|
486.23 cells/million T-cells
Standard Deviation 524.58
|
406.50 cells/million T-cells
Standard Deviation 364.57
|
543.11 cells/million T-cells
Standard Deviation 607.67
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IFN-γ - A/Vietnam, Month 6 + 21 Days
|
769.33 cells/million T-cells
Standard Deviation 858.31
|
831.31 cells/million T-cells
Standard Deviation 964.67
|
712.10 cells/million T-cells
Standard Deviation 806.47
|
908.75 cells/million T-cells
Standard Deviation 952.74
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IFN-γ - A/Vietnam, Month 12
|
751.16 cells/million T-cells
Standard Deviation 604.70
|
851.71 cells/million T-cells
Standard Deviation 727.68
|
817.48 cells/million T-cells
Standard Deviation 568.54
|
832.49 cells/million T-cells
Standard Deviation 1138.08
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IFN-γ - A/Indonesia, Month 18
|
657.19 cells/million T-cells
Standard Deviation 622.98
|
972.81 cells/million T-cells
Standard Deviation 1026.12
|
1017.82 cells/million T-cells
Standard Deviation 655.54
|
883.75 cells/million T-cells
Standard Deviation 969.20
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 IFN-γ - A/Vietnam, Month 18
|
698.55 cells/million T-cells
Standard Deviation 804.64
|
1018.23 cells/million T-cells
Standard Deviation 959.34
|
1066.89 cells/million T-cells
Standard Deviation 845.76
|
949.06 cells/million T-cells
Standard Deviation 949.59
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 TNF-α - A/Vietnam, Day 0
|
213.17 cells/million T-cells
Standard Deviation 314.89
|
290.55 cells/million T-cells
Standard Deviation 244.57
|
248.53 cells/million T-cells
Standard Deviation 334.40
|
262.12 cells/million T-cells
Standard Deviation 309.11
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 TNF-α - A/Vietnam, Month 6
|
389.55 cells/million T-cells
Standard Deviation 823.34
|
459.89 cells/million T-cells
Standard Deviation 709.54
|
501.89 cells/million T-cells
Standard Deviation 496.82
|
684.19 cells/million T-cells
Standard Deviation 700.61
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 TNF-α - A/Vietnam, Month 6 + 7 Days
|
605.80 cells/million T-cells
Standard Deviation 1282.37
|
700.69 cells/million T-cells
Standard Deviation 893.07
|
1160.60 cells/million T-cells
Standard Deviation 1524.45
|
972.71 cells/million T-cells
Standard Deviation 668.12
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 TNF-α - A/Vietnam, Month 6 + 21 Days
|
880.12 cells/million T-cells
Standard Deviation 1327.15
|
971.44 cells/million T-cells
Standard Deviation 1419.68
|
881.65 cells/million T-cells
Standard Deviation 1218.69
|
1227.63 cells/million T-cells
Standard Deviation 1871.42
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD4 TNF-α - A/Vietnam, Month 18
|
877.90 cells/million T-cells
Standard Deviation 810.80
|
1314.99 cells/million T-cells
Standard Deviation 846.99
|
1232.41 cells/million T-cells
Standard Deviation 1079.43
|
1147.21 cells/million T-cells
Standard Deviation 1402.58
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 All Doubles - A/Vietnam, Day 0
|
67.13 cells/million T-cells
Standard Deviation 366.43
|
26.91 cells/million T-cells
Standard Deviation 128.98
|
30.44 cells/million T-cells
Standard Deviation 219.02
|
45.07 cells/million T-cells
Standard Deviation 377.44
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 All Doubles - A/Vietnam, Month 6
|
20.86 cells/million T-cells
Standard Deviation 222.56
|
18.86 cells/million T-cells
Standard Deviation 271.65
|
37.69 cells/million T-cells
Standard Deviation 271.61
|
40.43 cells/million T-cells
Standard Deviation 148.42
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 All Doubles - A/Vietnam, Month 6 + 7 Days
|
23.01 cells/million T-cells
Standard Deviation 290.71
|
27.73 cells/million T-cells
Standard Deviation 93.80
|
38.78 cells/million T-cells
Standard Deviation 211.71
|
32.56 cells/million T-cells
Standard Deviation 150.48
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 All Doubles - A/Vietnam, Month 6 + 21 Days
|
29.21 cells/million T-cells
Standard Deviation 281.87
|
52.59 cells/million T-cells
Standard Deviation 159.49
|
36.47 cells/million T-cells
Standard Deviation 171.22
|
16.93 cells/million T-cells
Standard Deviation 105.56
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 All Doubles - A/Indonesia, Month 12
|
47.78 cells/million T-cells
Standard Deviation 1206.89
|
31.69 cells/million T-cells
Standard Deviation 1136.66
|
64.08 cells/million T-cells
Standard Deviation 1893.94
|
36.18 cells/million T-cells
Standard Deviation 1567.28
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 All Doubles - A/Vietnam, Month 12
|
15.04 cells/million T-cells
Standard Deviation 544.79
|
21.08 cells/million T-cells
Standard Deviation 635.65
|
37.32 cells/million T-cells
Standard Deviation 744.75
|
14.09 cells/million T-cells
Standard Deviation 771.65
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 All Doubles - A/Indonesia, Month 18
|
48.27 cells/million T-cells
Standard Deviation 1109.56
|
24.19 cells/million T-cells
Standard Deviation 1162.30
|
82.90 cells/million T-cells
Standard Deviation 1266.82
|
34.07 cells/million T-cells
Standard Deviation 1414.34
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 CD40L - A/Vietnam, Month 6 + 7 Days
|
6.26 cells/million T-cells
Standard Deviation 71.82
|
3.55 cells/million T-cells
Standard Deviation 30.06
|
6.28 cells/million T-cells
Standard Deviation 34.99
|
5.92 cells/million T-cells
Standard Deviation 45.82
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 CD40L - A/Indonesia, Month 12
|
3.92 cells/million T-cells
Standard Deviation 58.33
|
5.74 cells/million T-cells
Standard Deviation 93.30
|
9.05 cells/million T-cells
Standard Deviation 186.92
|
7.74 cells/million T-cells
Standard Deviation 144.04
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 CD40L - A/Vietnam, Month 12
|
2.27 cells/million T-cells
Standard Deviation 33.81
|
3.40 cells/million T-cells
Standard Deviation 67.73
|
5.10 cells/million T-cells
Standard Deviation 65.14
|
3.35 cells/million T-cells
Standard Deviation 47.52
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 CD40L - A/Indonesia, Month 18
|
5.88 cells/million T-cells
Standard Deviation 71.14
|
5.23 cells/million T-cells
Standard Deviation 269.38
|
5.25 cells/million T-cells
Standard Deviation 71.46
|
3.66 cells/million T-cells
Standard Deviation 56.08
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IL-2 - A/Vietnam, Month 12
|
14.98 cells/million T-cells
Standard Deviation 532.13
|
21.52 cells/million T-cells
Standard Deviation 631.86
|
31.94 cells/million T-cells
Standard Deviation 746.85
|
13.31 cells/million T-cells
Standard Deviation 773.02
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IL-2 - A/Indonesia, Month 18
|
43.26 cells/million T-cells
Standard Deviation 1110.98
|
19.50 cells/million T-cells
Standard Deviation 1164.40
|
66.29 cells/million T-cells
Standard Deviation 1268.66
|
33.60 cells/million T-cells
Standard Deviation 1414.79
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IFN-γ - A/Vietnam, Month 6 + 21 Days
|
9.86 cells/million T-cells
Standard Deviation 272.26
|
16.87 cells/million T-cells
Standard Deviation 111.49
|
15.44 cells/million T-cells
Standard Deviation 132.81
|
11.37 cells/million T-cells
Standard Deviation 82.16
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IFN-γ - A/Indonesia, Month 12
|
3.05 cells/million T-cells
Standard Deviation 131.52
|
4.05 cells/million T-cells
Standard Deviation 147.20
|
4.11 cells/million T-cells
Standard Deviation 75.97
|
2.83 cells/million T-cells
Standard Deviation 38.52
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 IFN-γ - A/Vietnam, Month 18
|
5.73 cells/million T-cells
Standard Deviation 64.14
|
3.55 cells/million T-cells
Standard Deviation 138.59
|
5.22 cells/million T-cells
Standard Deviation 95.47
|
3.15 cells/million T-cells
Standard Deviation 107.32
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 TNF-α - A/Vietnam, Month 6
|
11.60 cells/million T-cells
Standard Deviation 192.99
|
17.44 cells/million T-cells
Standard Deviation 260.42
|
21.86 cells/million T-cells
Standard Deviation 254.39
|
20.44 cells/million T-cells
Standard Deviation 140.65
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 TNF-α - A/Indonesia, Month 12
|
46.49 cells/million T-cells
Standard Deviation 1154.66
|
27.72 cells/million T-cells
Standard Deviation 1030.52
|
57.62 cells/million T-cells
Standard Deviation 1753.76
|
31.65 cells/million T-cells
Standard Deviation 1425.49
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 TNF-α - A/Vietnam, Month 12
|
13.46 cells/million T-cells
Standard Deviation 423.36
|
18.89 cells/million T-cells
Standard Deviation 579.22
|
35.19 cells/million T-cells
Standard Deviation 698.32
|
12.30 cells/million T-cells
Standard Deviation 725.71
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 TNF-α - A/Indonesia, Month 18
|
45.67 cells/million T-cells
Standard Deviation 1033.79
|
22.55 cells/million T-cells
Standard Deviation 1002.19
|
70.09 cells/million T-cells
Standard Deviation 1200.29
|
34.37 cells/million T-cells
Standard Deviation 1369.22
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6
CD8 TNF-α - A/Vietnam, Month 18
|
31.41 cells/million T-cells
Standard Deviation 580.62
|
12.96 cells/million T-cells
Standard Deviation 816.63
|
21.36 cells/million T-cells
Standard Deviation 614.44
|
9.31 cells/million T-cells
Standard Deviation 642.97
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 All Doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The 2 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=51 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=43 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Vietnam, Day 0
|
560.41 cells/million T-cells
Standard Deviation 427.07
|
529.20 cells/million T-cells
Standard Deviation 549.34
|
542.86 cells/million T-cells
Standard Deviation 488.28
|
771.60 cells/million T-cells
Standard Deviation 788.54
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Vietnam, Month 6
|
1296.63 cells/million T-cells
Standard Deviation 839.72
|
931.49 cells/million T-cells
Standard Deviation 717.72
|
1714.23 cells/million T-cells
Standard Deviation 837.39
|
1601.31 cells/million T-cells
Standard Deviation 1020.97
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Indonesia, Month 12
|
1379.04 cells/million T-cells
Standard Deviation 701.03
|
1254.05 cells/million T-cells
Standard Deviation 835.74
|
1690.38 cells/million T-cells
Standard Deviation 1135.04
|
1534.37 cells/million T-cells
Standard Deviation 1256.20
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Indonesia, Month 12 + 7 Days
|
1979.02 cells/million T-cells
Standard Deviation 1644.97
|
1763.05 cells/million T-cells
Standard Deviation 1266.55
|
3030.85 cells/million T-cells
Standard Deviation 1974.08
|
3202.67 cells/million T-cells
Standard Deviation 7114.42
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Vietnam, Month 12 + 7 days
|
2278.65 cells/million T-cells
Standard Deviation 2822.40
|
1856.17 cells/million T-cells
Standard Deviation 1517.33
|
2953.57 cells/million T-cells
Standard Deviation 2725.45
|
3502.70 cells/million T-cells
Standard Deviation 19908.39
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Indonesia, Month 18
|
2003.28 cells/million T-cells
Standard Deviation 964.77
|
1530.61 cells/million T-cells
Standard Deviation 1228.44
|
2975.66 cells/million T-cells
Standard Deviation 1696.72
|
2458.61 cells/million T-cells
Standard Deviation 1829.69
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Vietnam, Month 12 + 7 Days
|
2179.65 cells/million T-cells
Standard Deviation 2615.03
|
1781.72 cells/million T-cells
Standard Deviation 1287.53
|
2842.20 cells/million T-cells
Standard Deviation 2607.80
|
3365.20 cells/million T-cells
Standard Deviation 18999.95
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Indonesia, Month 12
|
1149.50 cells/million T-cells
Standard Deviation 571.65
|
1065.33 cells/million T-cells
Standard Deviation 661.19
|
1517.94 cells/million T-cells
Standard Deviation 1028.90
|
1293.00 cells/million T-cells
Standard Deviation 1103.73
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Vietnam, Month 12 + 7 Days
|
1897.17 cells/million T-cells
Standard Deviation 2415.04
|
1533.21 cells/million T-cells
Standard Deviation 1397.88
|
2477.58 cells/million T-cells
Standard Deviation 2347.38
|
2942.81 cells/million T-cells
Standard Deviation 17299.39
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Vietnam, Day 0
|
410.28 cells/million T-cells
Standard Deviation 363.50
|
336.74 cells/million T-cells
Standard Deviation 443.20
|
379.98 cells/million T-cells
Standard Deviation 364.14
|
476.66 cells/million T-cells
Standard Deviation 687.60
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Indonesia, Month 12
|
716.74 cells/million T-cells
Standard Deviation 400.83
|
609.84 cells/million T-cells
Standard Deviation 578.82
|
832.27 cells/million T-cells
Standard Deviation 746.45
|
794.44 cells/million T-cells
Standard Deviation 765.51
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Vietnam, Month 12 + 7 Days
|
1131.19 cells/million T-cells
Standard Deviation 1352.73
|
892.51 cells/million T-cells
Standard Deviation 905.48
|
1335.77 cells/million T-cells
Standard Deviation 1104.69
|
1635.21 cells/million T-cells
Standard Deviation 7167.21
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Indonesia, Month 12 + 21 Days
|
1245.91 cells/million T-cells
Standard Deviation 936.91
|
948.13 cells/million T-cells
Standard Deviation 1366.34
|
1540.77 cells/million T-cells
Standard Deviation 1136.61
|
1662.38 cells/million T-cells
Standard Deviation 1310.77
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Vietnam, Month 18
|
1309.65 cells/million T-cells
Standard Deviation 1177.92
|
901.99 cells/million T-cells
Standard Deviation 1416.15
|
1418.76 cells/million T-cells
Standard Deviation 1038.94
|
1284.53 cells/million T-cells
Standard Deviation 1281.98
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Vietnam, Day 0
|
355.17 cells/million T-cells
Standard Deviation 302.08
|
287.10 cells/million T-cells
Standard Deviation 423.56
|
341.11 cells/million T-cells
Standard Deviation 356.99
|
512.64 cells/million T-cells
Standard Deviation 572.95
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Vietnam, Month 6
|
886.97 cells/million T-cells
Standard Deviation 662.75
|
629.87 cells/million T-cells
Standard Deviation 556.20
|
1187.24 cells/million T-cells
Standard Deviation 710.18
|
1180.29 cells/million T-cells
Standard Deviation 829.76
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Indonesia, Month 12
|
1020.53 cells/million T-cells
Standard Deviation 642.48
|
896.53 cells/million T-cells
Standard Deviation 690.42
|
1251.38 cells/million T-cells
Standard Deviation 970.03
|
995.80 cells/million T-cells
Standard Deviation 1066.30
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Vietnam, Month 12
|
886.76 cells/million T-cells
Standard Deviation 457.39
|
673.80 cells/million T-cells
Standard Deviation 651.52
|
790.01 cells/million T-cells
Standard Deviation 938.28
|
903.64 cells/million T-cells
Standard Deviation 2220.85
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Indonesia, Month 12 + 7 Days
|
1198.25 cells/million T-cells
Standard Deviation 1200.42
|
1217.50 cells/million T-cells
Standard Deviation 971.57
|
2108.88 cells/million T-cells
Standard Deviation 1380.62
|
2379.07 cells/million T-cells
Standard Deviation 5801.63
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Vietnam, Month 12 + 7 Days
|
1289.39 cells/million T-cells
Standard Deviation 2162.71
|
1136.90 cells/million T-cells
Standard Deviation 1164.93
|
1997.48 cells/million T-cells
Standard Deviation 1725.20
|
2466.32 cells/million T-cells
Standard Deviation 16740.25
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Indonesia, Month 12 + 21 Days
|
2047.96 cells/million T-cells
Standard Deviation 1439.33
|
1515.97 cells/million T-cells
Standard Deviation 1751.14
|
2800.66 cells/million T-cells
Standard Deviation 2480.69
|
2510.61 cells/million T-cells
Standard Deviation 2450.88
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Vietnam, Month 12 + 21 Days
|
1833.81 cells/million T-cells
Standard Deviation 2015.18
|
1428.02 cells/million T-cells
Standard Deviation 1030.82
|
2373.80 cells/million T-cells
Standard Deviation 2542.38
|
2571.60 cells/million T-cells
Standard Deviation 3441.06
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Indonesia, Month 18
|
1461.90 cells/million T-cells
Standard Deviation 863.23
|
1009.39 cells/million T-cells
Standard Deviation 1077.18
|
2445.88 cells/million T-cells
Standard Deviation 1505.10
|
1979.21 cells/million T-cells
Standard Deviation 1590.60
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 TNF-α - A/Vietnam, Month 18
|
1499.43 cells/million T-cells
Standard Deviation 1302.01
|
1250.85 cells/million T-cells
Standard Deviation 1843.92
|
2269.35 cells/million T-cells
Standard Deviation 1494.81
|
1914.16 cells/million T-cells
Standard Deviation 2270.93
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Vietnam, Day 0
|
33.23 cells/million T-cells
Standard Deviation 473.07
|
30.79 cells/million T-cells
Standard Deviation 332.90
|
18.67 cells/million T-cells
Standard Deviation 297.54
|
21.71 cells/million T-cells
Standard Deviation 163.41
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Vietnam, Month 6
|
56.22 cells/million T-cells
Standard Deviation 359.78
|
60.15 cells/million T-cells
Standard Deviation 348.65
|
31.83 cells/million T-cells
Standard Deviation 296.96
|
34.66 cells/million T-cells
Standard Deviation 208.62
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Indonesia, Month 12
|
41.20 cells/million T-cells
Standard Deviation 285.40
|
19.96 cells/million T-cells
Standard Deviation 258.08
|
33.27 cells/million T-cells
Standard Deviation 237.99
|
34.16 cells/million T-cells
Standard Deviation 449.53
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Vietnam, Month 12
|
14.72 cells/million T-cells
Standard Deviation 293.17
|
13.96 cells/million T-cells
Standard Deviation 149.10
|
8.90 cells/million T-cells
Standard Deviation 107.93
|
30.14 cells/million T-cells
Standard Deviation 365.90
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Indonesia, Month 12 + 7 Days
|
68.32 cells/million T-cells
Standard Deviation 385.82
|
48.09 cells/million T-cells
Standard Deviation 292.33
|
41.66 cells/million T-cells
Standard Deviation 276.01
|
57.43 cells/million T-cells
Standard Deviation 369.42
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Vietnam, Month 12 + 7 Days
|
18.73 cells/million T-cells
Standard Deviation 398.89
|
23.11 cells/million T-cells
Standard Deviation 409.70
|
9.04 cells/million T-cells
Standard Deviation 325.93
|
62.81 cells/million T-cells
Standard Deviation 426.34
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Indonesia, Month 12 + 21 Days
|
59.21 cells/million T-cells
Standard Deviation 402.04
|
22.21 cells/million T-cells
Standard Deviation 196.85
|
42.28 cells/million T-cells
Standard Deviation 213.86
|
60.95 cells/million T-cells
Standard Deviation 301.71
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Vietnam, Month 12 + 21 Days
|
16.35 cells/million T-cells
Standard Deviation 341.81
|
10.06 cells/million T-cells
Standard Deviation 260.79
|
16.58 cells/million T-cells
Standard Deviation 227.02
|
51.01 cells/million T-cells
Standard Deviation 320.71
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Indonesia, Month 18
|
45.87 cells/million T-cells
Standard Deviation 268.24
|
36.98 cells/million T-cells
Standard Deviation 349.38
|
29.12 cells/million T-cells
Standard Deviation 194.72
|
36.73 cells/million T-cells
Standard Deviation 391.36
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 All Doubles - A/Vietnam, Month 18
|
27.14 cells/million T-cells
Standard Deviation 378.73
|
17.52 cells/million T-cells
Standard Deviation 231.65
|
26.49 cells/million T-cells
Standard Deviation 396.90
|
17.79 cells/million T-cells
Standard Deviation 189.35
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Vietnam, Day 0
|
3.05 cells/million T-cells
Standard Deviation 54.73
|
3.22 cells/million T-cells
Standard Deviation 55.84
|
2.48 cells/million T-cells
Standard Deviation 130.89
|
2.79 cells/million T-cells
Standard Deviation 19.72
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Vietnam, Month 6
|
2.59 cells/million T-cells
Standard Deviation 24.33
|
3.07 cells/million T-cells
Standard Deviation 55.80
|
3.00 cells/million T-cells
Standard Deviation 101.52
|
1.51 cells/million T-cells
Standard Deviation 20.14
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Indonesia, Month 12
|
2.09 cells/million T-cells
Standard Deviation 28.38
|
3.66 cells/million T-cells
Standard Deviation 26.90
|
4.44 cells/million T-cells
Standard Deviation 40.48
|
4.48 cells/million T-cells
Standard Deviation 83.08
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Vietnam, Month 12
|
2.33 cells/million T-cells
Standard Deviation 34.71
|
2.47 cells/million T-cells
Standard Deviation 32.62
|
2.16 cells/million T-cells
Standard Deviation 52.15
|
2.87 cells/million T-cells
Standard Deviation 40.66
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Indonesia, Month 12 + 7 Days
|
8.21 cells/million T-cells
Standard Deviation 51.25
|
7.68 cells/million T-cells
Standard Deviation 119.95
|
13.23 cells/million T-cells
Standard Deviation 99.16
|
7.76 cells/million T-cells
Standard Deviation 99.48
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Vietnam, Month 12 + 7 Days
|
4.40 cells/million T-cells
Standard Deviation 30.87
|
2.90 cells/million T-cells
Standard Deviation 183.17
|
2.90 cells/million T-cells
Standard Deviation 39.63
|
10.59 cells/million T-cells
Standard Deviation 52.19
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Indonesia, Month 12 + 21 Days
|
5.43 cells/million T-cells
Standard Deviation 73.31
|
5.98 cells/million T-cells
Standard Deviation 61.91
|
8.29 cells/million T-cells
Standard Deviation 57.18
|
7.45 cells/million T-cells
Standard Deviation 96.27
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Vietnam, Month 12 + 21 Days
|
3.96 cells/million T-cells
Standard Deviation 67.70
|
2.44 cells/million T-cells
Standard Deviation 92.98
|
3.11 cells/million T-cells
Standard Deviation 32.25
|
3.70 cells/million T-cells
Standard Deviation 34.54
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Indonesia, Month 18
|
3.52 cells/million T-cells
Standard Deviation 49.19
|
4.22 cells/million T-cells
Standard Deviation 56.87
|
2.45 cells/million T-cells
Standard Deviation 37.14
|
2.75 cells/million T-cells
Standard Deviation 36.15
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 CD40L - A/Vietnam, Month 18
|
4.32 cells/million T-cells
Standard Deviation 59.02
|
3.84 cells/million T-cells
Standard Deviation 75.59
|
4.78 cells/million T-cells
Standard Deviation 62.03
|
2.09 cells/million T-cells
Standard Deviation 59.01
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Vietnam, Day 0
|
18.34 cells/million T-cells
Standard Deviation 169.79
|
22.25 cells/million T-cells
Standard Deviation 202.40
|
10.40 cells/million T-cells
Standard Deviation 167.00
|
15.03 cells/million T-cells
Standard Deviation 86.58
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Vietnam, Month 6
|
24.13 cells/million T-cells
Standard Deviation 246.71
|
30.85 cells/million T-cells
Standard Deviation 186.03
|
16.53 cells/million T-cells
Standard Deviation 173.90
|
19.63 cells/million T-cells
Standard Deviation 145.48
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Indonesia, Month 12
|
29.84 cells/million T-cells
Standard Deviation 250.29
|
18.29 cells/million T-cells
Standard Deviation 246.48
|
17.80 cells/million T-cells
Standard Deviation 236.04
|
28.56 cells/million T-cells
Standard Deviation 430.21
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Vietnam, Month 12
|
9.12 cells/million T-cells
Standard Deviation 276.25
|
12.06 cells/million T-cells
Standard Deviation 148.06
|
8.22 cells/million T-cells
Standard Deviation 80.21
|
35.92 cells/million T-cells
Standard Deviation 362.09
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Indonesia, Month 12 + 7 Days
|
55.96 cells/million T-cells
Standard Deviation 393.80
|
36.88 cells/million T-cells
Standard Deviation 268.94
|
28.07 cells/million T-cells
Standard Deviation 261.31
|
61.72 cells/million T-cells
Standard Deviation 318.59
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Vietnam, Month 12 + 7 Days
|
20.48 cells/million T-cells
Standard Deviation 385.51
|
23.40 cells/million T-cells
Standard Deviation 399.09
|
8.29 cells/million T-cells
Standard Deviation 278.07
|
52.32 cells/million T-cells
Standard Deviation 392.40
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Indonesia, Month 12 + 21 Days
|
62.99 cells/million T-cells
Standard Deviation 387.92
|
19.97 cells/million T-cells
Standard Deviation 198.10
|
31.51 cells/million T-cells
Standard Deviation 216.34
|
43.10 cells/million T-cells
Standard Deviation 277.22
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Vietnam, Month 12 + 21 Days
|
12.52 cells/million T-cells
Standard Deviation 278.19
|
8.59 cells/million T-cells
Standard Deviation 207.18
|
14.20 cells/million T-cells
Standard Deviation 208.85
|
47.66 cells/million T-cells
Standard Deviation 280.88
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Indonesia, Month 18
|
45.30 cells/million T-cells
Standard Deviation 266.64
|
31.29 cells/million T-cells
Standard Deviation 340.10
|
19.06 cells/million T-cells
Standard Deviation 157.42
|
31.56 cells/million T-cells
Standard Deviation 385.23
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IL-2 - A/Vietnam, Month 18
|
15.35 cells/million T-cells
Standard Deviation 281.28
|
15.08 cells/million T-cells
Standard Deviation 211.25
|
14.48 cells/million T-cells
Standard Deviation 250.77
|
21.78 cells/million T-cells
Standard Deviation 153.80
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Vietnam, Day 0
|
38.69 cells/million T-cells
Standard Deviation 468.52
|
22.01 cells/million T-cells
Standard Deviation 312.45
|
16.63 cells/million T-cells
Standard Deviation 273.01
|
24.90 cells/million T-cells
Standard Deviation 165.67
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Vietnam, Month 6
|
31.09 cells/million T-cells
Standard Deviation 359.03
|
42.77 cells/million T-cells
Standard Deviation 334.23
|
24.28 cells/million T-cells
Standard Deviation 290.45
|
30.08 cells/million T-cells
Standard Deviation 200.12
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Indonesia, Month 12
|
10.22 cells/million T-cells
Standard Deviation 195.65
|
6.58 cells/million T-cells
Standard Deviation 85.93
|
19.40 cells/million T-cells
Standard Deviation 172.59
|
13.70 cells/million T-cells
Standard Deviation 342.47
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Vietnam, Month 12
|
5.79 cells/million T-cells
Standard Deviation 214.35
|
7.07 cells/million T-cells
Standard Deviation 174.18
|
4.31 cells/million T-cells
Standard Deviation 101.18
|
9.04 cells/million T-cells
Standard Deviation 120.34
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Indonesia, Month 12 + 7 Days
|
13.38 cells/million T-cells
Standard Deviation 163.26
|
15.65 cells/million T-cells
Standard Deviation 111.26
|
10.25 cells/million T-cells
Standard Deviation 163.04
|
18.89 cells/million T-cells
Standard Deviation 170.88
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Vietnam, Month 12 + 7 Days
|
7.58 cells/million T-cells
Standard Deviation 253.61
|
7.45 cells/million T-cells
Standard Deviation 181.01
|
7.59 cells/million T-cells
Standard Deviation 236.89
|
41.24 cells/million T-cells
Standard Deviation 348.65
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Indonesia, Month 12 + 21 Days
|
13.88 cells/million T-cells
Standard Deviation 121.34
|
7.48 cells/million T-cells
Standard Deviation 123.95
|
6.66 cells/million T-cells
Standard Deviation 65.20
|
13.34 cells/million T-cells
Standard Deviation 135.85
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Vietnam, Month 12 + 21 Days
|
11.90 cells/million T-cells
Standard Deviation 273.59
|
6.84 cells/million T-cells
Standard Deviation 235.75
|
6.18 cells/million T-cells
Standard Deviation 111.67
|
15.18 cells/million T-cells
Standard Deviation 269.18
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Indonesia, Month 18
|
8.53 cells/million T-cells
Standard Deviation 121.12
|
12.19 cells/million T-cells
Standard Deviation 79.29
|
7.77 cells/million T-cells
Standard Deviation 113.83
|
6.53 cells/million T-cells
Standard Deviation 164.84
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 IFN-γ - A/Vietnam, Month 18
|
13.33 cells/million T-cells
Standard Deviation 342.90
|
9.36 cells/million T-cells
Standard Deviation 182.90
|
5.10 cells/million T-cells
Standard Deviation 351.48
|
7.33 cells/million T-cells
Standard Deviation 135.83
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Vietnam, Day 0
|
24.58 cells/million T-cells
Standard Deviation 437.31
|
19.36 cells/million T-cells
Standard Deviation 258.56
|
11.36 cells/million T-cells
Standard Deviation 179.18
|
14.50 cells/million T-cells
Standard Deviation 136.30
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Vietnam, Month 6
|
31.78 cells/million T-cells
Standard Deviation 296.04
|
25.01 cells/million T-cells
Standard Deviation 272.87
|
26.33 cells/million T-cells
Standard Deviation 205.26
|
30.46 cells/million T-cells
Standard Deviation 172.62
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Indonesia, Month 12
|
29.30 cells/million T-cells
Standard Deviation 263.60
|
15.38 cells/million T-cells
Standard Deviation 263.83
|
24.41 cells/million T-cells
Standard Deviation 194.37
|
25.59 cells/million T-cells
Standard Deviation 330.65
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Vietnam, Month 12
|
8.92 cells/million T-cells
Standard Deviation 240.77
|
11.32 cells/million T-cells
Standard Deviation 106.95
|
6.46 cells/million T-cells
Standard Deviation 81.15
|
19.46 cells/million T-cells
Standard Deviation 337.02
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Indonesia, Month 12 + 7 Days
|
54.30 cells/million T-cells
Standard Deviation 362.16
|
34.22 cells/million T-cells
Standard Deviation 261.37
|
35.18 cells/million T-cells
Standard Deviation 233.51
|
32.53 cells/million T-cells
Standard Deviation 309.18
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Vietnam, Month 12 + 7 Days
|
10.89 cells/million T-cells
Standard Deviation 363.87
|
17.27 cells/million T-cells
Standard Deviation 340.50
|
8.21 cells/million T-cells
Standard Deviation 300.02
|
44.13 cells/million T-cells
Standard Deviation 394.01
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Indonesia, Month 12 + 21 Days
|
48.83 cells/million T-cells
Standard Deviation 375.84
|
23.41 cells/million T-cells
Standard Deviation 155.91
|
31.57 cells/million T-cells
Standard Deviation 210.43
|
45.94 cells/million T-cells
Standard Deviation 281.82
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Vietnam, Month 12 + 21 Days
|
14.75 cells/million T-cells
Standard Deviation 282.33
|
10.85 cells/million T-cells
Standard Deviation 228.98
|
8.45 cells/million T-cells
Standard Deviation 210.82
|
35.54 cells/million T-cells
Standard Deviation 288.39
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Indonesia, Month 18
|
41.13 cells/million T-cells
Standard Deviation 261.84
|
24.97 cells/million T-cells
Standard Deviation 337.40
|
27.31 cells/million T-cells
Standard Deviation 164.07
|
31.10 cells/million T-cells
Standard Deviation 361.58
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD8 TNF-α - A/Vietnam, Month 18
|
16.41 cells/million T-cells
Standard Deviation 310.32
|
14.16 cells/million T-cells
Standard Deviation 217.05
|
16.70 cells/million T-cells
Standard Deviation 368.21
|
18.60 cells/million T-cells
Standard Deviation 170.85
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Vietnam, Month 12
|
1230.51 cells/million T-cells
Standard Deviation 523.55
|
1093.54 cells/million T-cells
Standard Deviation 941.19
|
1260.93 cells/million T-cells
Standard Deviation 1118.44
|
1224.35 cells/million T-cells
Standard Deviation 2953.68
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Indonesia, Month 12 + 21 Days
|
2837.94 cells/million T-cells
Standard Deviation 1587.84
|
2180.14 cells/million T-cells
Standard Deviation 2032.36
|
3600.62 cells/million T-cells
Standard Deviation 2903.90
|
3221.46 cells/million T-cells
Standard Deviation 2824.65
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Vietnam, Month 12 + 21 Days
|
2651.19 cells/million T-cells
Standard Deviation 2181.61
|
2276.18 cells/million T-cells
Standard Deviation 1434.51
|
3386.98 cells/million T-cells
Standard Deviation 3153.08
|
3603.01 cells/million T-cells
Standard Deviation 3804.83
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 All Doubles - A/Vietnam, Month 18
|
2230.56 cells/million T-cells
Standard Deviation 1780.46
|
1628.90 cells/million T-cells
Standard Deviation 2059.72
|
2972.79 cells/million T-cells
Standard Deviation 1797.59
|
2535.97 cells/million T-cells
Standard Deviation 2627.53
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Vietnam, Day 0
|
536.99 cells/million T-cells
Standard Deviation 406.96
|
505.20 cells/million T-cells
Standard Deviation 497.95
|
504.23 cells/million T-cells
Standard Deviation 476.25
|
729.16 cells/million T-cells
Standard Deviation 736.68
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Vietnam, Month 6
|
1272.27 cells/million T-cells
Standard Deviation 819.74
|
891.65 cells/million T-cells
Standard Deviation 657.93
|
1659.46 cells/million T-cells
Standard Deviation 823.79
|
1548.04 cells/million T-cells
Standard Deviation 918.09
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Indonesia, Month 12
|
1361.91 cells/million T-cells
Standard Deviation 670.66
|
1209.07 cells/million T-cells
Standard Deviation 715.01
|
1610.40 cells/million T-cells
Standard Deviation 1079.91
|
1478.55 cells/million T-cells
Standard Deviation 1259.28
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Vietnam, Month 12
|
1189.38 cells/million T-cells
Standard Deviation 519.31
|
1059.77 cells/million T-cells
Standard Deviation 917.49
|
1217.48 cells/million T-cells
Standard Deviation 1056.53
|
1173.39 cells/million T-cells
Standard Deviation 2904.15
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Indonesia, Month 12 + 7 Days
|
1968.90 cells/million T-cells
Standard Deviation 1594.19
|
1724.77 cells/million T-cells
Standard Deviation 1242.19
|
2880.43 cells/million T-cells
Standard Deviation 1936.74
|
3101.88 cells/million T-cells
Standard Deviation 6940.95
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Indonesia, Month 12 + 21 Days
|
2744.31 cells/million T-cells
Standard Deviation 1545.16
|
2097.74 cells/million T-cells
Standard Deviation 1860.85
|
3431.78 cells/million T-cells
Standard Deviation 2897.09
|
3124.45 cells/million T-cells
Standard Deviation 2787.90
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Vietnam, Month 12 + 21 Days
|
2583.09 cells/million T-cells
Standard Deviation 2102.23
|
2184.58 cells/million T-cells
Standard Deviation 1371.47
|
3179.78 cells/million T-cells
Standard Deviation 3132.51
|
3479.95 cells/million T-cells
Standard Deviation 3622.29
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Indonesia, Month 18
|
1943.30 cells/million T-cells
Standard Deviation 922.92
|
1532.05 cells/million T-cells
Standard Deviation 1186.69
|
2859.97 cells/million T-cells
Standard Deviation 1657.11
|
2317.11 cells/million T-cells
Standard Deviation 1865.51
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 CD40L - A/Vietnam, Month 18
|
2174.81 cells/million T-cells
Standard Deviation 1734.47
|
1755.83 cells/million T-cells
Standard Deviation 1930.06
|
2849.08 cells/million T-cells
Standard Deviation 1755.65
|
2483.47 cells/million T-cells
Standard Deviation 2583.46
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Vietnam, Day 0
|
376.07 cells/million T-cells
Standard Deviation 336.28
|
409.33 cells/million T-cells
Standard Deviation 480.49
|
436.65 cells/million T-cells
Standard Deviation 411.16
|
612.11 cells/million T-cells
Standard Deviation 632.55
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Vietnam, Month 6
|
1097.97 cells/million T-cells
Standard Deviation 712.55
|
804.03 cells/million T-cells
Standard Deviation 632.15
|
1461.85 cells/million T-cells
Standard Deviation 769.17
|
1403.84 cells/million T-cells
Standard Deviation 915.32
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Vietnam, Month 12
|
992.70 cells/million T-cells
Standard Deviation 427.17
|
814.08 cells/million T-cells
Standard Deviation 714.13
|
1083.65 cells/million T-cells
Standard Deviation 1008.19
|
1048.97 cells/million T-cells
Standard Deviation 2636.29
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Indonesia, Month 12 + 7 Days
|
1498.36 cells/million T-cells
Standard Deviation 1396.73
|
1476.33 cells/million T-cells
Standard Deviation 1015.37
|
2543.33 cells/million T-cells
Standard Deviation 1712.80
|
2670.96 cells/million T-cells
Standard Deviation 5571.66
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Indonesia, Month 12 + 21 Days
|
2392.88 cells/million T-cells
Standard Deviation 1398.76
|
1858.04 cells/million T-cells
Standard Deviation 1721.69
|
3108.60 cells/million T-cells
Standard Deviation 2632.60
|
2747.73 cells/million T-cells
Standard Deviation 2516.72
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Vietnam, Month 12 + 21 Days
|
2268.27 cells/million T-cells
Standard Deviation 1995.17
|
1932.19 cells/million T-cells
Standard Deviation 1276.22
|
2992.35 cells/million T-cells
Standard Deviation 2869.19
|
3105.21 cells/million T-cells
Standard Deviation 3366.65
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Indonesia, Month 18
|
1703.60 cells/million T-cells
Standard Deviation 838.53
|
1383.29 cells/million T-cells
Standard Deviation 1077.39
|
2559.41 cells/million T-cells
Standard Deviation 1683.14
|
2104.29 cells/million T-cells
Standard Deviation 1607.98
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IL-2 - A/Vietnam, Month 18
|
1869.31 cells/million T-cells
Standard Deviation 1525.68
|
1394.95 cells/million T-cells
Standard Deviation 1933.81
|
2589.97 cells/million T-cells
Standard Deviation 1776.18
|
2162.08 cells/million T-cells
Standard Deviation 2461.02
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Vietnam, Month 6
|
690.45 cells/million T-cells
Standard Deviation 600.77
|
539.79 cells/million T-cells
Standard Deviation 432.94
|
771.40 cells/million T-cells
Standard Deviation 459.71
|
748.72 cells/million T-cells
Standard Deviation 758.34
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Vietnam, Month 12
|
729.77 cells/million T-cells
Standard Deviation 345.26
|
565.44 cells/million T-cells
Standard Deviation 574.28
|
633.07 cells/million T-cells
Standard Deviation 650.52
|
767.14 cells/million T-cells
Standard Deviation 1198.67
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Indonesia, Month 12 + 7 Days
|
973.45 cells/million T-cells
Standard Deviation 756.29
|
812.11 cells/million T-cells
Standard Deviation 693.80
|
1308.07 cells/million T-cells
Standard Deviation 966.01
|
1560.86 cells/million T-cells
Standard Deviation 2907.99
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Vietnam, Month 12 + 21 Days
|
1278.22 cells/million T-cells
Standard Deviation 1209.43
|
1074.61 cells/million T-cells
Standard Deviation 717.53
|
1539.76 cells/million T-cells
Standard Deviation 1287.82
|
1795.04 cells/million T-cells
Standard Deviation 2122.78
|
—
|
—
|
—
|
—
|
|
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12
CD4 IFN-γ - A/Indonesia, Month 18
|
1113.27 cells/million T-cells
Standard Deviation 598.27
|
902.31 cells/million T-cells
Standard Deviation 742.69
|
1329.00 cells/million T-cells
Standard Deviation 814.58
|
1292.88 cells/million T-cells
Standard Deviation 1081.31
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=56 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=50 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Vietnam, Day 0
|
20.4 Titers
Interval 16.9 to 24.8
|
22.2 Titers
Interval 17.8 to 27.6
|
18.9 Titers
Interval 15.8 to 22.7
|
19.8 Titers
Interval 16.2 to 24.1
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Vietnam, Day 21
|
117.9 Titers
Interval 91.8 to 151.5
|
106.7 Titers
Interval 86.7 to 131.2
|
179.6 Titers
Interval 93.5 to 345.0
|
78.8 Titers
Interval 28.3 to 219.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Vietnam, Day 42
|
—
|
—
|
372.3 Titers
Interval 286.5 to 483.8
|
429.8 Titers
Interval 319.1 to 578.9
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Vietnam, Month 6
|
39.7 Titers
Interval 30.8 to 51.0
|
39.2 Titers
Interval 31.2 to 49.2
|
88.8 Titers
Interval 64.0 to 123.1
|
91.2 Titers
Interval 71.8 to 115.9
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 7 Days
|
778.7 Titers
Interval 623.8 to 972.1
|
1113.9 Titers
Interval 857.8 to 1446.5
|
945.3 Titers
Interval 729.8 to 1224.5
|
1058.8 Titers
Interval 828.7 to 1352.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 21 Days
|
1392.3 Titers
Interval 1065.5 to 1819.2
|
1435.9 Titers
Interval 1074.8 to 1918.4
|
1922.0 Titers
Interval 1436.1 to 2572.4
|
1625.2 Titers
Interval 1192.6 to 2214.6
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Vietnam, Month 12
|
646.3 Titers
Interval 539.0 to 775.0
|
762.9 Titers
Interval 611.3 to 952.1
|
795.6 Titers
Interval 577.1 to 1097.0
|
823.6 Titers
Interval 600.5 to 1129.6
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Indonesia, Day 0
|
15.7 Titers
Interval 14.5 to 17.0
|
15.5 Titers
Interval 13.9 to 17.2
|
15.4 Titers
Interval 14.1 to 16.9
|
14.4 Titers
Interval 13.8 to 15.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Indonesia, Day 21
|
39.8 Titers
Interval 32.4 to 48.8
|
32.0 Titers
Interval 26.6 to 38.5
|
37.9 Titers
Interval 18.1 to 79.6
|
33.3 Titers
Interval 19.1 to 58.2
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Indonesia, Day 42
|
—
|
—
|
87.9 Titers
Interval 68.1 to 113.4
|
75.9 Titers
Interval 59.4 to 96.9
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 7 Days
|
966.7 Titers
Interval 762.0 to 1226.3
|
512.4 Titers
Interval 411.8 to 637.6
|
1016.1 Titers
Interval 759.5 to 1359.4
|
562.0 Titers
Interval 457.2 to 690.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 21 Days
|
1815.5 Titers
Interval 1368.0 to 2409.3
|
674.4 Titers
Interval 536.9 to 847.1
|
2334.1 Titers
Interval 1712.4 to 3181.4
|
831.3 Titers
Interval 644.7 to 1071.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Indonesia, Month 12
|
672.9 Titers
Interval 527.4 to 858.7
|
392.1 Titers
Interval 329.2 to 467.0
|
1003.8 Titers
Interval 751.2 to 1341.4
|
540.0 Titers
Interval 406.6 to 717.3
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6
A/Indonesia, Month 6
|
22.0 Titers
Interval 18.2 to 26.6
|
21.7 Titers
Interval 18.1 to 25.9
|
41.7 Titers
Interval 31.2 to 55.7
|
30.5 Titers
Interval 23.7 to 39.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=59 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=60 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Indonesia, Day 0
|
15.8 Titers
Interval 14.3 to 17.5
|
15.7 Titers
Interval 14.4 to 17.2
|
15.1 Titers
Interval 14.0 to 16.3
|
15.5 Titers
Interval 14.1 to 17.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Indonesia, Day 21
|
43.5 Titers
Interval 35.0 to 54.0
|
37.0 Titers
Interval 29.2 to 46.8
|
31.3 Titers
Interval 18.3 to 53.5
|
26.5 Titers
Interval 17.1 to 41.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Indonesia, Day 42
|
—
|
—
|
97.0 Titers
Interval 71.2 to 132.1
|
83.6 Titers
Interval 67.8 to 103.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Indonesia, Month 6
|
144.2 Titers
Interval 107.2 to 194.0
|
122.4 Titers
Interval 99.2 to 150.9
|
259.6 Titers
Interval 195.6 to 344.5
|
196.3 Titers
Interval 165.1 to 233.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Indonesia, Month 12
|
124.7 Titers
Interval 93.8 to 165.8
|
106.5 Titers
Interval 80.2 to 141.5
|
234.6 Titers
Interval 196.7 to 279.9
|
197.5 Titers
Interval 155.0 to 251.6
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
2025.2 Titers
Interval 1505.1 to 2725.1
|
936.9 Titers
Interval 730.9 to 1200.9
|
2556.6 Titers
Interval 1917.7 to 3408.4
|
1102.4 Titers
Interval 770.2 to 1577.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
3254.2 Titers
Interval 2325.5 to 4553.9
|
1301.5 Titers
Interval 984.4 to 1720.7
|
4602.2 Titers
Interval 3621.0 to 5849.3
|
1708.3 Titers
Interval 1277.3 to 2284.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Vietnam, Day 0
|
21.0 Titers
Interval 17.2 to 25.5
|
20.6 Titers
Interval 17.7 to 23.9
|
20.3 Titers
Interval 16.7 to 24.6
|
20.0 Titers
Interval 16.4 to 24.3
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Vietnam, Day 21
|
124.4 Titers
Interval 93.8 to 165.1
|
99.2 Titers
Interval 80.2 to 122.6
|
80.2 Titers
Interval 49.5 to 129.9
|
104.6 Titers
Interval 35.3 to 310.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Vietnam, Day 42
|
—
|
—
|
500.2 Titers
Interval 360.5 to 693.9
|
404.4 Titers
Interval 321.5 to 508.7
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Vietnam, Month 6
|
270.6 Titers
Interval 216.5 to 338.2
|
223.2 Titers
Interval 191.7 to 259.9
|
401.9 Titers
Interval 302.2 to 534.4
|
334.2 Titers
Interval 267.0 to 418.3
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Vietnam, Month 12
|
551.9 Titers
Interval 431.3 to 706.4
|
504.0 Titers
Interval 412.6 to 615.7
|
474.3 Titers
Interval 395.3 to 568.9
|
468.1 Titers
Interval 405.1 to 540.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
1848.1 Titers
Interval 1453.8 to 2349.4
|
1448.5 Titers
Interval 1175.5 to 1784.9
|
2002.2 Titers
Interval 1533.7 to 2613.9
|
1718.1 Titers
Interval 1301.3 to 2268.4
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
3209.7 Titers
Interval 2461.3 to 4185.6
|
2520.3 Titers
Interval 1914.2 to 3318.3
|
3874.7 Titers
Interval 2944.6 to 5098.5
|
2304.8 Titers
Interval 1747.6 to 3039.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18Population: The analysis was performed on the ATP Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=51 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=44 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 0
|
15.7 Titers
Interval 14.4 to 17.1
|
15.3 Titers
Interval 13.7 to 17.1
|
15.5 Titers
Interval 14.2 to 17.1
|
14.4 Titers
Interval 13.8 to 15.1
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 21
|
40.6 Titers
Interval 32.5 to 50.6
|
31.8 Titers
Interval 25.9 to 38.9
|
37.9 Titers
Interval 18.1 to 79.6
|
36.4 Titers
Interval 18.6 to 71.1
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 42
|
—
|
—
|
86.3 Titers
Interval 66.5 to 111.9
|
76.7 Titers
Interval 61.0 to 96.3
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6
|
20.7 Titers
Interval 17.4 to 24.7
|
22.2 Titers
Interval 18.3 to 26.8
|
40.9 Titers
Interval 30.3 to 55.0
|
29.2 Titers
Interval 22.6 to 37.7
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6+ 7 Days
|
906.1 Titers
Interval 708.4 to 1158.8
|
526.2 Titers
Interval 419.4 to 660.2
|
963.3 Titers
Interval 713.9 to 1299.9
|
537.3 Titers
Interval 431.1 to 669.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 21 Days
|
1703.0 Titers
Interval 1263.7 to 2295.0
|
707.6 Titers
Interval 556.5 to 899.8
|
2224.0 Titers
Interval 1613.6 to 3065.3
|
814.7 Titers
Interval 629.8 to 1053.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 12
|
678.0 Titers
Interval 525.5 to 874.7
|
392.1 Titers
Interval 329.2 to 467.0
|
995.8 Titers
Interval 740.6 to 1339.0
|
533.4 Titers
Interval 399.2 to 712.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 18
|
361.1 Titers
Interval 283.8 to 459.6
|
225.0 Titers
Interval 175.0 to 289.2
|
447.6 Titers
Interval 345.2 to 580.5
|
290.1 Titers
Interval 211.1 to 398.7
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 0
|
20.9 Titers
Interval 17.0 to 25.8
|
22.0 Titers
Interval 17.5 to 27.6
|
19.3 Titers
Interval 16.0 to 23.4
|
20.4 Titers
Interval 16.5 to 25.2
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 21
|
119.0 Titers
Interval 91.5 to 154.7
|
109.0 Titers
Interval 87.2 to 136.2
|
179.6 Titers
Interval 93.5 to 345.0
|
103.6 Titers
Interval 30.4 to 352.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 42
|
—
|
—
|
352.9 Titers
Interval 272.3 to 457.4
|
449.3 Titers
Interval 338.8 to 596.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 7 Days
|
727.6 Titers
Interval 579.8 to 913.0
|
1167.5 Titers
Interval 893.0 to 1526.2
|
910.3 Titers
Interval 700.4 to 1183.1
|
1035.0 Titers
Interval 794.6 to 1348.1
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 21 Days
|
1296.1 Titers
Interval 985.1 to 1705.3
|
1568.2 Titers
Interval 1176.0 to 2091.2
|
1863.6 Titers
Interval 1387.9 to 2502.4
|
1609.1 Titers
Interval 1162.2 to 2227.7
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 12
|
643.3 Titers
Interval 532.4 to 777.4
|
762.9 Titers
Interval 611.3 to 952.1
|
797.7 Titers
Interval 574.3 to 1107.9
|
844.7 Titers
Interval 613.7 to 1162.7
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 18
|
277.7 Titers
Interval 208.2 to 370.3
|
338.1 Titers
Interval 254.2 to 449.6
|
358.9 Titers
Interval 254.4 to 506.2
|
444.5 Titers
Interval 310.4 to 636.6
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6
|
35.9 Titers
Interval 28.2 to 45.6
|
39.8 Titers
Interval 31.1 to 51.0
|
86.1 Titers
Interval 61.6 to 120.4
|
91.4 Titers
Interval 72.2 to 115.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18Population: The analysis was performed on the ATP Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=53 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=45 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 0
|
15.9 Titer
Interval 14.2 to 17.9
|
15.6 Titer
Interval 14.3 to 17.1
|
15.4 Titer
Interval 14.0 to 16.9
|
15.7 Titer
Interval 14.1 to 17.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 21
|
45.1 Titer
Interval 35.4 to 57.4
|
40.0 Titer
Interval 31.1 to 51.5
|
31.3 Titer
Interval 18.3 to 53.5
|
26.3 Titer
Interval 16.1 to 43.0
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 42
|
—
|
—
|
100.8 Titer
Interval 68.6 to 148.1
|
80.7 Titer
Interval 65.4 to 99.6
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 6
|
146.5 Titer
Interval 108.3 to 198.0
|
123.3 Titer
Interval 99.6 to 152.6
|
255.0 Titer
Interval 188.5 to 345.0
|
196.3 Titer
Interval 165.1 to 233.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12
|
127.0 Titer
Interval 95.7 to 168.5
|
107.8 Titer
Interval 80.5 to 144.3
|
231.3 Titer
Interval 191.6 to 279.3
|
197.5 Titer
Interval 155.0 to 251.6
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
2190.6 Titer
Interval 1657.3 to 2895.6
|
947.5 Titer
Interval 732.7 to 1225.4
|
2476.1 Titer
Interval 1839.2 to 3333.5
|
1102.4 Titer
Interval 770.2 to 1577.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
3722.1 Titer
Interval 2850.5 to 4860.1
|
1303.0 Titer
Interval 975.7 to 1740.0
|
4661.0 Titer
Interval 3625.1 to 5993.0
|
1708.3 Titer
Interval 1277.3 to 2284.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 18
|
903.0 Titer
Interval 667.6 to 1221.5
|
423.7 Titer
Interval 320.9 to 559.5
|
1708.9 Titer
Interval 1243.6 to 2348.4
|
620.6 Titer
Interval 475.5 to 809.9
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 0
|
20.5 Titer
Interval 16.5 to 25.4
|
20.8 Titer
Interval 17.7 to 24.5
|
20.8 Titer
Interval 16.6 to 26.1
|
20.5 Titer
Interval 16.5 to 25.4
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 21
|
123.7 Titer
Interval 93.6 to 163.6
|
103.6 Titer
Interval 82.1 to 130.8
|
80.2 Titer
Interval 49.5 to 129.9
|
116.2 Titer
Interval 33.9 to 398.1
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 42
|
—
|
—
|
469.2 Titer
Interval 321.4 to 684.8
|
399.2 Titer
Interval 321.7 to 495.4
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 6
|
274.5 Titer
Interval 218.3 to 345.4
|
223.1 Titer
Interval 190.4 to 261.4
|
405.1 Titer
Interval 298.8 to 549.3
|
334.2 Titer
Interval 267.0 to 418.3
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12
|
542.7 Titer
Interval 417.6 to 705.2
|
511.2 Titer
Interval 415.6 to 628.9
|
475.9 Titer
Interval 393.1 to 576.1
|
468.1 Titer
Interval 405.1 to 540.8
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
1945.3 Titer
Interval 1532.8 to 2468.9
|
1435.4 Titer
Interval 1163.3 to 1771.1
|
1972.2 Titer
Interval 1490.9 to 2609.0
|
1718.1 Titer
Interval 1301.3 to 2268.4
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
3490.4 Titer
Interval 2712.8 to 4491.0
|
2495.4 Titer
Interval 1886.4 to 3300.9
|
4057.4 Titer
Interval 3048.1 to 5400.9
|
2304.8 Titer
Interval 1747.6 to 3039.5
|
—
|
—
|
—
|
—
|
|
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 18
|
813.2 Titer
Interval 580.8 to 1138.5
|
585.9 Titer
Interval 417.5 to 822.2
|
1650.0 Titer
Interval 1203.4 to 2262.4
|
871.9 Titer
Interval 621.0 to 1224.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12Population: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
Seroconversion (SCR) was defined as the percentage of vaccinees with a minimum 4-fold increase in neutralizing antibody titer at the post-vaccination time-point compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=56 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=55 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=49 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 21
|
19 Participants
|
13 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Day 42
|
—
|
—
|
32 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6
|
6 Participants
|
5 Participants
|
20 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 7 Days
|
53 Participants
|
46 Participants
|
48 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 21 Days
|
51 Participants
|
47 Participants
|
49 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 12
|
47 Participants
|
42 Participants
|
46 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 21
|
40 Participants
|
34 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Day 42
|
—
|
—
|
42 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6
|
18 Participants
|
10 Participants
|
28 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 7 Days
|
51 Participants
|
45 Participants
|
48 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 21 Days
|
52 Participants
|
45 Participants
|
49 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 12
|
47 Participants
|
42 Participants
|
45 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.
Seroconversion (SCR) was defined as the percentage of vaccinees with a minimum 4-fold increase in neutralizing antibody titer at the post-vaccination time-point compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=58 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=60 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 21
|
19 Participants
|
17 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Day 42
|
—
|
—
|
35 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 6
|
45 Participants
|
44 Participants
|
43 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12
|
41 Participants
|
39 Participants
|
42 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
51 Participants
|
49 Participants
|
42 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
50 Participants
|
50 Participants
|
43 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
50 Participants
|
49 Participants
|
41 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
51 Participants
|
50 Participants
|
42 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 21
|
40 Participants
|
38 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Day 42
|
—
|
—
|
43 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 6
|
51 Participants
|
50 Participants
|
40 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12
|
48 Participants
|
49 Participants
|
43 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18Population: This analysis was performed on the ATP Cohort for Immunogenicity (only for M12) and ATP Cohort for Persistence, which included all evaluable subjects for whom immunogenicity data/long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster SCR was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=42 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=46 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=43 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 21 Days
|
46 Participants
|
41 Participants
|
45 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 18
|
40 Participants
|
32 Participants
|
38 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 7 Days
|
44 Participants
|
40 Participants
|
35 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 6 + 21 Days
|
46 Participants
|
41 Participants
|
39 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 12
|
46 Participants
|
39 Participants
|
33 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Vietnam, Month 18
|
33 Participants
|
35 Participants
|
26 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 6 + 7 Days
|
48 Participants
|
41 Participants
|
43 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6
A/Indonesia, Month 12
|
47 Participants
|
40 Participants
|
44 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 12 + 7 Days and Month 12 + 21 DaysPopulation: This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=51 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=50 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=43 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=40 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
46 Participants
|
39 Participants
|
42 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
17 Participants
|
16 Participants
|
18 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
31 Participants
|
25 Participants
|
31 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
42 Participants
|
35 Participants
|
34 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 12 + 7 Days, Month 12 + 21 Days and Month 18Population: The analysis was performed on the ATP Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.
Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.
Outcome measures
| Measure |
GSK1562902A V/I/6 Group
n=47 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=48 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=40 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=40 Participants
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 7 Days
|
39 Participants
|
34 Participants
|
32 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 12 + 21 Days
|
44 Participants
|
38 Participants
|
39 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Indonesia, Month 18
|
33 Participants
|
25 Participants
|
31 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 7 Days
|
15 Participants
|
15 Participants
|
17 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 12 + 21 Days
|
30 Participants
|
23 Participants
|
29 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12
A/Vietnam, Month 18
|
8 Participants
|
7 Participants
|
16 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
GSK1562902A V/I/6 Group
GSK1562902A V/V/6 Group
GSK1562902A 2V/I/6 Group
GSK1562902A 2V/V/6 Group
GSK1562902A V/I/12 Group
GSK1562902A V/V/12 Group
GSK1562902A 2V/I/12 Group
GSK1562902A 2V/V/12 Group
Serious adverse events
| Measure |
GSK1562902A V/I/6 Group
n=63 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=66 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=64 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=63 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
n=64 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
n=64 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
n=65 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
n=63 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Cardiac disorders
Sick sinus syndrome
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.5%
1/66 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Injury, poisoning and procedural complications
Concussion
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/64 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/64 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/64 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/64 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine neoplasm
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.5%
1/65 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/64 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/64 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/64 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Nervous system disorders
Hypoaesthesia
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Nervous system disorders
Multiple sclerosis
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
Other adverse events
| Measure |
GSK1562902A V/I/6 Group
n=63 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/6 Group
n=66 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/6 Group
n=64 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/6 Group
n=63 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/I/12 Group
n=64 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 1 dose of vaccine formulated from VT (A/Vietnam/1994/2004) strain at Day 0 and 1 dose of the vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A V/V/12 Group
n=64 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/I/12 Group
n=65 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN (A/Indonesia/05/2005) strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
GSK1562902A 2V/V/12 Group
n=63 participants at risk
Healthy male or female subjects, between and including 18 and 60 years of age, who received 2 doses of vaccine formulated from VT (A/Vietnam/1994/2004) strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.7%
8/63 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
7.6%
5/66 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
10.9%
7/64 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
17.5%
11/63 • Number of events 12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
12.5%
8/64 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
12.5%
8/64 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
15.4%
10/65 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
7.9%
5/63 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.0%
17/63 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
39.4%
26/66 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
42.2%
27/64 • Number of events 40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
44.4%
28/63 • Number of events 47 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
31.2%
20/64 • Number of events 28 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
20.3%
13/64 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
44.6%
29/65 • Number of events 43 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
41.3%
26/63 • Number of events 35 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
General disorders
Chills
|
34.9%
22/63 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
42.4%
28/66 • Number of events 33 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
37.5%
24/64 • Number of events 37 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
57.1%
36/63 • Number of events 53 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
34.4%
22/64 • Number of events 32 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
31.2%
20/64 • Number of events 24 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
38.5%
25/65 • Number of events 36 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
46.0%
29/63 • Number of events 49 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
2/63 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.5%
1/66 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/64 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/64 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
3.1%
2/64 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
3.1%
2/65 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
6.3%
4/63 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.2%
2/63 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.5%
1/66 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
3.1%
2/64 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
3.1%
2/64 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
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: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
1.6%
1/63 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
17.5%
11/63 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
12.1%
8/66 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
25.0%
16/64 • Number of events 24 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
20.6%
13/63 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
12.5%
8/64 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
17.2%
11/64 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
20.0%
13/65 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
23.8%
15/63 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
General disorders
Fatigue
|
55.6%
35/63 • Number of events 48 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
56.1%
37/66 • Number of events 54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
70.3%
45/64 • Number of events 84 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
69.8%
44/63 • Number of events 77 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
57.8%
37/64 • Number of events 57 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
51.6%
33/64 • Number of events 43 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
72.3%
47/65 • Number of events 75 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
69.8%
44/63 • Number of events 81 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Nervous system disorders
Headache
|
55.6%
35/63 • Number of events 47 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
51.5%
34/66 • Number of events 48 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
65.6%
42/64 • Number of events 78 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
66.7%
42/63 • Number of events 83 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
50.0%
32/64 • Number of events 48 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
53.1%
34/64 • Number of events 47 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
69.2%
45/65 • Number of events 76 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
65.1%
41/63 • Number of events 71 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
23.8%
15/63 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
27.3%
18/66 • Number of events 19 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
35.9%
23/64 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
31.7%
20/63 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
25.0%
16/64 • Number of events 18 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
10.9%
7/64 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
35.4%
23/65 • Number of events 29 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
39.7%
25/63 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
General disorders
Induration
|
27.0%
17/63 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
19.7%
13/66 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
34.4%
22/64 • Number of events 35 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
39.7%
25/63 • Number of events 47 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
21.9%
14/64 • Number of events 18 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
25.0%
16/64 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
36.9%
24/65 • Number of events 38 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
30.2%
19/63 • Number of events 26 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
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: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
3.1%
2/64 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
4.8%
3/63 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
4.7%
3/64 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
0.00%
0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
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: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
4.8%
3/63 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
65.1%
41/63 • Number of events 57 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
62.1%
41/66 • Number of events 61 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
75.0%
48/64 • Number of events 94 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
76.2%
48/63 • Number of events 92 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
76.6%
49/64 • Number of events 71 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
64.1%
41/64 • Number of events 60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
69.2%
45/65 • Number of events 87 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
74.6%
47/63 • Number of events 88 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
General disorders
Pain
|
88.9%
56/63 • Number of events 96 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
93.9%
62/66 • Number of events 111 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
95.3%
61/64 • Number of events 157 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
93.7%
59/63 • Number of events 156 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
95.3%
61/64 • Number of events 107 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
89.1%
57/64 • Number of events 99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
95.4%
62/65 • Number of events 154 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
92.1%
58/63 • Number of events 145 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
General disorders
Pyrexia
|
9.5%
6/63 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
4.5%
3/66 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
6.2%
4/64 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
6.3%
4/63 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
7.8%
5/64 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
10.9%
7/64 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
7.7%
5/65 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
7.9%
5/63 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
|
General disorders
Swelling
|
19.0%
12/63 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
22.7%
15/66 • Number of events 19 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
32.8%
21/64 • Number of events 32 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
34.9%
22/63 • Number of events 37 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
15.6%
10/64 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
20.3%
13/64 • Number of events 17 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
24.6%
16/65 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
25.4%
16/63 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-primary and booster vaccination period; SAEs: during the entire study period (from Day 0 up to Month 18).
|
Additional Information
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