Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children (NCT NCT01323946)
NCT ID: NCT01323946
Last Updated: 2019-05-07
Results Overview
A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
At Day 192
Results posted on
2019-05-07
Participant Flow
During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
GSK1562902A 6 to 12 M Group
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
34
|
33
|
|
Overall Study
COMPLETED
|
43
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
GSK1562902A 6 to 12 M Group
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Parents refused the last blood draw
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
Baseline Characteristics
Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children
Baseline characteristics by cohort
| Measure |
GSK1562902A 6 to 12 M Group
n=46 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=34 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
8.3 Months
STANDARD_DEVIATION 1.56 • n=5 Participants
|
16.1 Months
STANDARD_DEVIATION 3.44 • n=7 Participants
|
29.6 Months
STANDARD_DEVIATION 3.38 • n=5 Participants
|
16.87 Months
STANDARD_DEVIATION 9.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian -South East Asian heritage, n(%)
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - east asian heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - caucasian / european heritage
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Day 192Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall.
A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=33 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=21 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=29 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=83 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
PRIMARY outcome
Timeframe: At Day 192Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall.
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=33 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=21 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=29 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=83 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
|
424.1 Titers
Interval 327.3 to 549.4
|
317.6 Titers
Interval 208.4 to 484.0
|
321.2 Titers
Interval 248.4 to 415.5
|
357.7 Titers
Interval 302.4 to 423.2
|
PRIMARY outcome
Timeframe: At Day 192Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall.
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=33 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=21 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=29 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=83 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 42, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=100 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005.HA [Day 0]
|
NA Titer
GMTs could not be computed as none of the subjects had HI antibody titers above the assay cut-off value of 1:10.
|
NA Titer
GMTs could not be computed as none of the subjects had HI antibody titers above the assay cut-off value of 1:10.
|
NA Titer
GMTs could not be computed as none of the subjects had HI antibody titers above the assay cut-off value of 1:10.
|
NA Titer
GMTs could not be computed as none of the subjects had HI antibody titers above the assay cut-off value of 1:10.
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005.HA [Day 42]
|
945.2 Titer
Interval 745.8 to 1197.9
|
1336.7 Titer
Interval 990.3 to 1804.2
|
1044.7 Titer
Interval 832.6 to 1310.9
|
1078.6 Titer
Interval 935.3 to 1243.7
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005.HA [Day 182]
|
160.0 Titer
Interval 125.4 to 204.2
|
147.3 Titer
Interval 113.2 to 191.7
|
133.7 Titer
Interval 113.1 to 158.1
|
147.2 Titer
Interval 129.6 to 167.1
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005.HA [Day 192]
|
2163.9 Titer
Interval 1772.7 to 2641.4
|
1534.7 Titer
Interval 1108.1 to 2125.5
|
1606.2 Titer
Interval 1254.3 to 2056.9
|
1787.6 Titer
Interval 1552.4 to 2058.3
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005.HA [Day 364]
|
1465.4 Titer
Interval 1168.2 to 1838.1
|
1055.8 Titer
Interval 769.2 to 1449.1
|
668.4 Titer
Interval 505.2 to 884.2
|
1043.3 Titer
Interval 886.1 to 1228.4
|
SECONDARY outcome
Timeframe: At Day 0, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=100 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005.HA [Day 0]
|
5.8 Titer
Interval 5.2 to 6.5
|
5.8 Titer
Interval 4.8 to 6.9
|
5.5 Titer
Interval 4.7 to 6.4
|
5.7 Titer
Interval 5.2 to 6.2
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005.HA [Day 182]
|
95.7 Titer
Interval 75.5 to 121.1
|
84.1 Titer
Interval 65.5 to 108.1
|
86.1 Titer
Interval 73.8 to 100.4
|
89.3 Titer
Interval 79.1 to 100.7
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005.HA [Day 192]
|
2454.6 Titer
Interval 1935.7 to 3112.6
|
1810.2 Titer
Interval 1207.1 to 2714.7
|
1767.4 Titer
Interval 1403.0 to 2226.3
|
2026.2 Titer
Interval 1731.3 to 2371.3
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005.HA [Day 364]
|
1810.1 Titer
Interval 1466.6 to 2234.0
|
1263.8 Titer
Interval 929.1 to 1719.0
|
803.4 Titer
Interval 609.7 to 1058.8
|
1266.8 Titer
Interval 1080.6 to 1485.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 42, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=100 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
A/Indonesia/05/2005.HA [Day 0]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
A/Indonesia/05/2005.HA [Day 42]
|
32 Participants
|
24 Participants
|
29 Participants
|
85 Participants
|
|
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
A/Indonesia/05/2005.HA [Day 182]
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
|
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
A/Indonesia/05/2005.HA [Day 192]
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
|
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
A/Indonesia/05/2005.HA [Day 364]
|
41 Participants
|
27 Participants
|
32 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=100 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005.HA [Day 0]
|
6 Participants
|
3 Participants
|
2 Participants
|
11 Participants
|
|
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005.HA [Day 182] 83
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
|
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005.HA [Day 192]
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
|
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005.HA [Day 364]
|
41 Participants
|
27 Participants
|
32 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: At Day 42, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer \<1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=100 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005.HA [Day 42]
|
32 Participants
|
24 Participants
|
29 Participants
|
85 Participants
|
|
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005.HA [Day 182]
|
32 Participants
|
21 Participants
|
29 Participants
|
82 Participants
|
|
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005.HA [Day 192]
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
|
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005.HA [Day 364]
|
41 Participants
|
27 Participants
|
32 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: At Day 182 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer \<1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=26 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=99 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/1/2005 H5N1 (Day 182)
|
31 Participants
|
20 Participants
|
28 Participants
|
83 Participants
|
|
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/1/2005 H5N1 (Day 364)
|
41 Participants
|
26 Participants
|
28 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 42, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=100 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
A/Indonesia/05/2005 H5N1.HA [Day 0]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
A/Indonesia/05/2005 H5N1.HA [Day 42]
|
32 Participants
|
24 Participants
|
29 Participants
|
85 Participants
|
|
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
A/Indonesia/05/2005 H5N1.HA [Day 182]
|
32 Participants
|
21 Participants
|
29 Participants
|
82 Participants
|
|
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
A/Indonesia/05/2005 H5N1.HA [Day 192]
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
|
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
A/Indonesia/05/2005 H5N1.HA [Day 364]
|
41 Participants
|
27 Participants
|
32 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 182 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0 and Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=100 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/1/2005 H5N1.HA [Day 0]
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/1/2005 H5N1.HA [Day 182]
|
31 Participants
|
21 Participants
|
29 Participants
|
81 Participants
|
|
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/1/2005 H5N1.HA [Day 364]
|
41 Participants
|
27 Participants
|
32 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: At Day 42, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=100 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005 H5N1.HA [Day 42]
|
189.0 Titer
Interval 149.2 to 239.6
|
267.3 Titer
Interval 198.1 to 360.8
|
208.9 Titer
Interval 166.5 to 262.2
|
215.7 Titer
Interval 187.1 to 248.7
|
|
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005 H5N1.HA [Day 182]
|
32.0 Titer
Interval 25.1 to 40.8
|
29.5 Titer
Interval 22.6 to 38.3
|
26.7 Titer
Interval 22.6 to 31.6
|
29.4 Titer
Interval 25.9 to 33.4
|
|
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005 H5N1.HA [Day 192]
|
432.8 Titer
Interval 354.5 to 528.3
|
306.9 Titer
Interval 221.6 to 425.1
|
321.2 Titer
Interval 250.9 to 411.4
|
357.5 Titer
Interval 310.5 to 411.7
|
|
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A/Indonesia/05/2005 H5N1.HA [Day 364]
|
293.1 Titer
Interval 233.6 to 367.6
|
211.2 Titer
Interval 153.8 to 289.8
|
133.7 Titer
Interval 101.0 to 176.8
|
208.7 Titer
Interval 177.2 to 245.7
|
SECONDARY outcome
Timeframe: Day 182 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=26 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=99 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
A/turkey/Turkey/1/2005 H5N1.HA [Day 182]
|
16.5 Titer
Interval 12.8 to 21.4
|
14.8 Titer
Interval 10.8 to 20.1
|
15.6 Titer
Interval 12.5 to 19.5
|
15.8 Titer
Interval 13.6 to 18.2
|
|
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
A/turkey/Turkey/1/2005 H5N1.HA [Day 364]
|
19.9 Titer
Interval 15.2 to 26.1
|
16.4 Titer
Interval 12.6 to 21.4
|
9.5 Titer
Interval 7.2 to 12.5
|
14.9 Titer
Interval 12.6 to 17.6
|
SECONDARY outcome
Timeframe: At Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall.
Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=26 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=99 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005 H5N1.HA [Day 192]
|
32 Participants
|
21 Participants
|
29 Participants
|
82 Participants
|
|
Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005 H5N1.HA [Day 364]
|
41 Participants
|
26 Participants
|
28 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: At Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall.
Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=41 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=26 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=32 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=99 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005 H5N1.HA [Day 192]
|
25.7 Titer
Interval 18.4 to 35.7
|
21.5 Titer
Interval 16.4 to 28.2
|
20.5 Titer
Interval 16.2 to 26.1
|
22.7 Titer
Interval 19.3 to 26.8
|
|
Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A/turkey/Turkey/01/2005 H5N1.HA [Day 364]
|
19.9 Titer
Interval 15.2 to 26.1
|
16.4 Titer
Interval 12.6 to 21.4
|
9.5 Titer
Interval 7.2 to 12.5
|
14.9 Titer
Interval 12.6 to 17.6
|
SECONDARY outcome
Timeframe: Day 0, Day 42, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=37 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=31 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=95 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 0]
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 42]
|
24 Participants
|
21 Participants
|
25 Participants
|
70 Participants
|
|
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 182]
|
32 Participants
|
21 Participants
|
28 Participants
|
81 Participants
|
|
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 192]
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
|
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 364]
|
37 Participants
|
27 Participants
|
31 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=37 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=31 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=95 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 0]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 182]
|
32 Participants
|
21 Participants
|
28 Participants
|
81 Participants
|
|
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 192]
|
33 Participants
|
21 Participants
|
29 Participants
|
83 Participants
|
|
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 364]
|
37 Participants
|
27 Participants
|
31 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 42, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
Titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=37 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=31 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=95 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 0]
|
NA Titer
Data could not be computed as none of the subjects had serum neutralizing antibody titers above the assay cut-off value of 1:28.
|
NA Titer
Data could not be computed as none of the subjects had serum neutralizing antibody titers above the assay cut-off value of 1:28.
|
14.4 Titer
Interval 13.6 to 15.3
|
14.1 Titer
Interval 13.9 to 14.4
|
|
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 42]
|
1785.9 Titer
Interval 1168.6 to 2729.5
|
2080.4 Titer
Interval 1422.8 to 3041.7
|
1755.2 Titer
Interval 1191.3 to 2586.1
|
1858.0 Titer
Interval 1491.3 to 2315.0
|
|
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 182]
|
526.6 Titer
Interval 397.1 to 698.2
|
483.3 Titer
Interval 333.1 to 701.3
|
353.4 Titer
Interval 273.7 to 456.2
|
448.7 Titer
Interval 379.0 to 531.2
|
|
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 192]
|
12667.0 Titer
Interval 10522.9 to 15248.1
|
11031.5 Titer
Interval 8157.8 to 14917.5
|
9883.1 Titer
Interval 7631.9 to 12798.4
|
11215.7 Titer
Interval 9797.4 to 12839.2
|
|
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 364]
|
6420.9 Titer
Interval 4851.0 to 8498.9
|
4730.9 Titer
Interval 3237.5 to 6913.0
|
2422.9 Titer
Interval 1674.9 to 3504.9
|
4283.3 Titer
Interval 3485.8 to 5263.2
|
SECONDARY outcome
Timeframe: Day 0, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
Titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=37 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=27 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=31 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=95 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 0]
|
NA Titer
Data could not be computed as none of the subjects had serum neutralizing antibody titers above the assay cut-off value of 1:28.
|
NA Titer
Data could not be computed as none of the subjects had serum neutralizing antibody titers above the assay cut-off value of 1:28.
|
NA Titer
Data could not be computed as none of the subjects had serum neutralizing antibody titers above the assay cut-off value of 1:28.
|
NA Titer
Data could not be computed as none of the subjects had serum neutralizing antibody titers above the assay cut-off value of 1:28.
|
|
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 182]
|
137.5 Titer
Interval 108.3 to 174.7
|
124.9 Titer
Interval 104.3 to 149.5
|
113.2 Titer
Interval 96.2 to 133.2
|
125.4 Titer
Interval 111.6 to 140.8
|
|
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 192]
|
7391.0 Titer
Interval 5117.8 to 10674.0
|
5464.2 Titer
Interval 3426.9 to 8712.7
|
3349.4 Titer
Interval 2249.8 to 4986.4
|
5192.9 Titer
Interval 4101.3 to 6575.1
|
|
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 364]
|
4149.7 Titer
Interval 3028.8 to 5685.4
|
3030.8 Titer
Interval 2036.2 to 4511.4
|
1317.8 Titer
Interval 898.4 to 1933.0
|
2610.2 Titer
Interval 2085.3 to 3267.2
|
SECONDARY outcome
Timeframe: At Day 42, Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=33 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=25 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=25 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=83 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 42]
|
22 Participants
|
19 Participants
|
21 Participants
|
62 Participants
|
|
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 182]
|
28 Participants
|
19 Participants
|
22 Participants
|
69 Participants
|
|
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 192]
|
29 Participants
|
19 Participants
|
24 Participants
|
72 Participants
|
|
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Flu A/Ind/05/05 (H5N1) [Day 364]
|
33 Participants
|
25 Participants
|
25 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: At Day 182, Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=33 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=25 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=25 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=83 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 182]
|
22 Participants
|
17 Participants
|
19 Participants
|
58 Participants
|
|
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 192]
|
29 Participants
|
19 Participants
|
24 Participants
|
72 Participants
|
|
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 364]
|
33 Participants
|
25 Participants
|
25 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: At Day 192 and Day 364Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall.
Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182)
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=32 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=24 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=23 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=79 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 192]
|
27 Participants
|
19 Participants
|
23 Participants
|
69 Participants
|
|
Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Flu A/Turk/01/05 (H5N1) [Day 364]
|
32 Participants
|
22 Participants
|
22 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented and with the symptom sheet filled-in. Analyses were done by age stratum and overall.
Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=46 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=33 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=112 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 1
|
14 Participants
|
5 Participants
|
13 Participants
|
32 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 1
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 1
|
2 Participants
|
0 Participants
|
2 Participants
|
4 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
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling Dose 1
|
1 Participants
|
1 Participants
|
1 Participants
|
3 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
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 2
|
10 Participants
|
13 Participants
|
14 Participants
|
37 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 2
|
3 Participants
|
2 Participants
|
1 Participants
|
6 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
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling Dose 2
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 3
|
20 Participants
|
15 Participants
|
18 Participants
|
53 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 3
|
3 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 3
|
11 Participants
|
5 Participants
|
2 Participants
|
18 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
|
5 Participants
|
5 Participants
|
1 Participants
|
11 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 Pain Across doses
|
26 Participants
|
19 Participants
|
21 Participants
|
66 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Across doses
|
4 Participants
|
1 Participants
|
5 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness Across doses
|
13 Participants
|
6 Participants
|
3 Participants
|
22 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
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling Across doses
|
6 Participants
|
6 Participants
|
1 Participants
|
13 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented and with the symptom sheet filled-in. Analyses were done by age stratum and overall.
Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=46 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=33 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=112 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (Axillary) Dose 2
|
14 Participants
|
12 Participants
|
10 Participants
|
36 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 2
|
8 Participants
|
12 Participants
|
7 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/fussiness Dose 2
|
14 Participants
|
17 Participants
|
10 Participants
|
41 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/fussiness Dose 2
|
1 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/fussiness Dose 2
|
13 Participants
|
15 Participants
|
10 Participants
|
38 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 2
|
8 Participants
|
6 Participants
|
9 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 2
|
8 Participants
|
5 Participants
|
8 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (Axillary) Dose 2
|
14 Participants
|
12 Participants
|
10 Participants
|
36 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 2
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 2
|
8 Participants
|
10 Participants
|
7 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhoea/vomiting Dose 3
|
10 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhoea/vomiting Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhoea/vomiting Dose 3
|
9 Participants
|
2 Participants
|
1 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (Axillary) Dose 2
|
2 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 3
|
16 Participants
|
6 Participants
|
10 Participants
|
32 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 3
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 3
|
16 Participants
|
6 Participants
|
7 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/fussiness Dose 3
|
28 Participants
|
15 Participants
|
11 Participants
|
54 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/fussiness Dose 3
|
7 Participants
|
0 Participants
|
2 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/fussiness Dose 3
|
26 Participants
|
15 Participants
|
10 Participants
|
51 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 3
|
16 Participants
|
12 Participants
|
9 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 3
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 3
|
15 Participants
|
12 Participants
|
7 Participants
|
34 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (Axillary) Dose 3
|
20 Participants
|
15 Participants
|
19 Participants
|
54 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (Axillary) Dose 3
|
3 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (Axillary) Dose 3
|
19 Participants
|
15 Participants
|
18 Participants
|
52 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhoea/vomiting Across doses
|
17 Participants
|
11 Participants
|
7 Participants
|
35 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhoea/vomiting Across doses
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhoea/vomiting Across doses
|
14 Participants
|
5 Participants
|
3 Participants
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Across doses
|
22 Participants
|
18 Participants
|
12 Participants
|
52 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Across doses
|
3 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Across doses
|
21 Participants
|
17 Participants
|
12 Participants
|
50 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/fussiness Across doses
|
35 Participants
|
23 Participants
|
15 Participants
|
73 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/fussiness Across doses
|
10 Participants
|
3 Participants
|
2 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/fussiness Across doses
|
35 Participants
|
23 Participants
|
14 Participants
|
72 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Across doses
|
22 Participants
|
18 Participants
|
14 Participants
|
54 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Across doses
|
2 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Across doses
|
19 Participants
|
17 Participants
|
14 Participants
|
50 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (Axillary) Across doses
|
29 Participants
|
19 Participants
|
21 Participants
|
69 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (Axillary) Across doses
|
5 Participants
|
8 Participants
|
4 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (Axillary) Across doses
|
28 Participants
|
19 Participants
|
20 Participants
|
67 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhoea/vomiting Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhoea/vomiting Dose 1
|
10 Participants
|
6 Participants
|
3 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhoea/vomiting Dose 1
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhoea/vomiting Dose 1
|
6 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 1
|
10 Participants
|
9 Participants
|
5 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 1
|
8 Participants
|
7 Participants
|
5 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/fussiness Dose 1
|
21 Participants
|
14 Participants
|
9 Participants
|
44 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/fussiness Dose 1
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/fussiness Dose 1
|
19 Participants
|
10 Participants
|
8 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 1
|
9 Participants
|
12 Participants
|
6 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 1
|
5 Participants
|
8 Participants
|
5 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (Axillary) Dose 1
|
4 Participants
|
6 Participants
|
4 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (Axillary) Dose 1
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (Axillary) Dose 1
|
3 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhoea/vomiting Dose 2
|
8 Participants
|
3 Participants
|
2 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhoea/vomiting Dose 2
|
7 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 to Day 364)Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=46 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=34 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=113 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With Medically-attended Events (MAEs)
|
29 Participants
|
19 Participants
|
20 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from day 0 to Day 364)Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=46 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=34 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=113 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=46 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=34 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=113 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Any AE(s)
|
29 Participants
|
19 Participants
|
24 Participants
|
72 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
5 Participants
|
3 Participants
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Related AE(s)
|
13 Participants
|
5 Participants
|
7 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=46 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=34 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=113 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Any AE(s)
|
32 Participants
|
23 Participants
|
22 Participants
|
77 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
4 Participants
|
4 Participants
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Related AE(s)
|
9 Participants
|
3 Participants
|
6 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 to 364)Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Outcome measures
| Measure |
GSK1562902A 6 to 12 M Group
n=46 Participants
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=34 Participants
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 Participants
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A Group
n=113 Participants
Subjects received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
5 Participants
|
4 Participants
|
0 Participants
|
9 Participants
|
Adverse Events
GSK1562902A 6 to 12 M Group
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
GSK1562902A 12 to 24 M Group
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
GSK1562902A 24 to 36 M Group
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1562902A 6 to 12 M Group
n=46 participants at risk
Subjects between 6 and 12 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=34 participants at risk
Subjects between 12 and 24 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 participants at risk
Subjects between 24 and 36 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Bronchiolitis
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
5.9%
2/34 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
5.9%
2/34 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.3%
2/46 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
Other adverse events
| Measure |
GSK1562902A 6 to 12 M Group
n=46 participants at risk
Subjects between 6 and 12 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 12 to 24 M Group
n=34 participants at risk
Subjects between 12 and 24 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
GSK1562902A 24 to 36 M Group
n=33 participants at risk
Subjects between 24 and 36 months of age, who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Investigations
Body temperature increased
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
5.9%
2/34 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Eye disorders
Chalazion
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
General disorders
Chest discomfort
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
5.9%
2/34 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
General disorders
Injection site haematoma
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
General disorders
Injection site induration
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
General disorders
Injection site rash
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
General disorders
Injection site scab
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Psychiatric disorders
Irritability
|
76.1%
35/46 • Number of events 63 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
67.6%
23/34 • Number of events 46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
45.5%
15/33 • Number of events 30 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
3/46 • Number of events 3 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
14.7%
5/34 • Number of events 8 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
6.1%
2/33 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Otitis media
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
General disorders
Pain
|
58.7%
27/46 • Number of events 45 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
55.9%
19/34 • Number of events 33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
63.6%
21/33 • Number of events 45 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Eye disorders
Conjunctivitis
|
4.3%
2/46 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
9/46 • Number of events 13 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
23.5%
8/34 • Number of events 8 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
6.1%
2/33 • Number of events 6 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Croup infectious
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
47.8%
22/46 • Number of events 33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
52.9%
18/34 • Number of events 30 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
42.4%
14/33 • Number of events 24 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
8.8%
3/34 • Number of events 3 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
6.1%
2/33 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
8.8%
3/34 • Number of events 3 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
28.3%
13/46 • Number of events 16 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
17.6%
6/34 • Number of events 7 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
9.1%
3/33 • Number of events 5 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Eye disorders
Eye pain
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Vascular disorders
Haematoma
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
General disorders
Pyrexia
|
67.4%
31/46 • Number of events 45 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
58.8%
20/34 • Number of events 39 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
66.7%
22/33 • Number of events 40 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
3/46 • Number of events 3 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Rhinitis
|
10.9%
5/46 • Number of events 6 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
6.1%
2/33 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
23.9%
11/46 • Number of events 12 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
5.9%
2/34 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
9.1%
3/33 • Number of events 4 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Roseola
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Nervous system disorders
Somnolence
|
47.8%
22/46 • Number of events 34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
52.9%
18/34 • Number of events 27 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
36.4%
12/33 • Number of events 22 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
General disorders
Swelling
|
13.0%
6/46 • Number of events 8 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
17.6%
6/34 • Number of events 8 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Gastrointestinal disorders
Teething
|
10.9%
5/46 • Number of events 7 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
6.1%
2/33 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
2.9%
1/34 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Upper respiratory tract infection
|
19.6%
9/46 • Number of events 11 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
14.7%
5/34 • Number of events 6 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
36.4%
12/33 • Number of events 14 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
9.1%
3/33 • Number of events 3 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Varicella
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Infections and infestations
Viral rash
|
2.2%
1/46 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/34 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
3.0%
1/33 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Gastrointestinal disorders
Vomiting
|
37.0%
17/46 • Number of events 30 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
32.4%
11/34 • Number of events 15 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
30.3%
10/33 • Number of events 12 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/46 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
5.9%
2/34 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
0.00%
0/33 • Serious Adverse Events: From Day 0 to Day 364; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 84-day (Days 0-84) post-vaccination period.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER