Trial Outcomes & Findings for Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children (NCT NCT01014091)
NCT ID: NCT01014091
Last Updated: 2018-09-21
Results Overview
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
At Day 42
Results posted on
2018-09-21
Participant Flow
From a total of 60 subjects enrolled in the study only 58 were vaccinated.
Participant milestones
| Measure |
GSK2340272A F1 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F1 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
13
|
5
|
15
|
6
|
12
|
|
Overall Study
COMPLETED
|
7
|
13
|
5
|
15
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children
Baseline characteristics by cohort
| Measure |
GSK2340272A F1 Y3-5 Group
n=7 Participants
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F1 Y6-9 Group
n=13 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y3-5 Group
n=5 Participants
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
n=15 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
n=6 Participants
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
n=12 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
4.1 Years
STANDARD_DEVIATION 0.9 • n=99 Participants
|
7.5 Years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
3.8 Years
STANDARD_DEVIATION 0.84 • n=206 Participants
|
7.3 Years
STANDARD_DEVIATION 0.9 • n=7 Participants
|
3.8 Years
STANDARD_DEVIATION 0.98 • n=31 Participants
|
7.6 Years
STANDARD_DEVIATION 0.9 • n=30 Participants
|
6.36 Years
STANDARD_DEVIATION 1.90 • n=3 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
20 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
38 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen
|
954.6 Titers
Interval 730.0 to 1248.4
|
838.1 Titers
Interval 647.0 to 1085.5
|
359.1 Titers
Interval 219.8 to 586.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies
|
13 Participants
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
Seroconversion (SCR) was defined as: For initially seronegative subjects \[pre-vaccination titer below (\<) 1:10\], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects in Terms of HI Antibodies
|
13 Participants
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for HI Antibodies
|
13 Participants
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
|
64 Fold change
Interval 25.9 to 158.2
|
71.9 Fold change
Interval 24.4 to 212.1
|
40.3 Fold change
Interval 27.0 to 60.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21 and Month 7Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies
Flu A/CAL/7/09, Day 0
|
6 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies
Flu A/CAL/7/09, Day 21
|
13 Participants
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies
Flu A/CAL/7/09, Month 7
|
13 Participants
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21 and Month 7Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
HI Antibody Titers Against Vaccine H1N1 Antigen
Flu A/CAL/7/09, Day 21
|
429.1 Titers
Interval 268.9 to 684.6
|
285.3 Titers
Interval 137.7 to 591.1
|
123.2 Titers
Interval 40.5 to 374.9
|
—
|
—
|
—
|
|
HI Antibody Titers Against Vaccine H1N1 Antigen
Flu A/CAL/7/09, Day 0
|
14.9 Titers
Interval 6.9 to 32.0
|
11.7 Titers
Interval 4.2 to 32.1
|
8.9 Titers
Interval 4.9 to 16.2
|
—
|
—
|
—
|
|
HI Antibody Titers Against Vaccine H1N1 Antigen
Flu A/CAL/7/09, Month 7
|
155.9 Titers
Interval 104.1 to 233.6
|
108.7 Titers
Interval 61.2 to 192.9
|
84.8 Titers
Interval 53.7 to 134.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21 and Month 7Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
Seroconversion (SCR) was defined as: For initially seronegative subjects (pre-vaccination titer below \< 1:10), a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects in Terms of HI Antibodies
Flu A/CAL/7/09, Day 21
|
13 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects in Terms of HI Antibodies
Flu A/CAL/7/09, Month 7
|
12 Participants
|
7 Participants
|
10 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21 and Month 7Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for HI Antibodies
Flu A/CAL/7/09, Day 0
|
6 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies
Flu A/CAL/7/09, Day 21
|
13 Participants
|
9 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies
Flu A/CAL/7/09, Month 7
|
13 Participants
|
8 Participants
|
11 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21 and Month 7Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=9 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
Flu A/CAL/7/09, Month 7
|
10.5 Fold change
Interval 6.0 to 18.3
|
9.3 Fold change
Interval 3.6 to 23.9
|
9.5 Fold change
Interval 5.9 to 15.3
|
—
|
—
|
—
|
|
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
Flu A/CAL/7/09, Day 21
|
28.8 Fold change
Interval 16.4 to 50.5
|
24.5 Fold change
Interval 10.0 to 59.7
|
13.8 Fold change
Interval 7.2 to 26.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 pain (children below 6 years of age) = cried when limb was moved/spontaneously painful. Grade 3 pain (children above 6 years of age) = significant pain at rest; pain that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=7 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=5 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
n=15 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
n=6 Participants
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
n=12 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
6 Participants
|
13 Participants
|
3 Participants
|
12 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
5 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
4 Participants
|
6 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
5 Participants
|
12 Participants
|
3 Participants
|
12 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
4 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
5 Participants
|
9 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
6 Participants
|
13 Participants
|
4 Participants
|
13 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
5 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
6 Participants
|
10 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the vaccination
Outcome measures
| Measure |
GSK2340272A F1 Group
n=7 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=5 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=6 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Across doses
|
4 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across doses
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Across doses
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across doses
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across doses
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 = symptom which prevented normal everyday activity. Related = symptom assessed by the investigator as causally related to the vaccination. Grade 3 fever = fever \> 39.0 °C.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=15 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=12 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
5 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 1
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
7 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature/(Axillary), Dose 1
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature/(Axillary), Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature/(Axillary), Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
6 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
|
4 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
6 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature/(Axillary), Dose 2
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature/(Axillary), Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature/(Axillary), Dose 2
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across doses
|
6 Participants
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across doses
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Across doses
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Across doses
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across doses
|
10 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across doses
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across doses
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature/(Axillary), Across doses
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature/(Axillary), Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature/(Axillary), Across doses
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (from Month 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
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.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=7 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=5 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
n=15 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
n=6 Participants
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
n=12 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Medically-attended Events (MAEs)
|
4 Participants
|
11 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Month 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. 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 |
GSK2340272A F1 Group
n=7 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=5 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
n=15 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
n=6 Participants
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
n=12 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 42-day (Days 0-41) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=7 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=5 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
n=15 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
n=6 Participants
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
n=12 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Any AE(s)
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Related AE(s)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Month 0 to Month 12)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK2340272A F1 Group
n=7 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Group
n=13 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Group
n=5 Participants
Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
n=15 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
n=6 Participants
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
n=12 Participants
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
GSK2340272A F1 Y3-5 Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
GSK2340272A F1 Y6-9 Group
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
GSK2340272A F2 Y3-5 Group
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
GSK2340272A F2 Y6-9 Group
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
GSK2340272A F3 Y3-5 Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK2340272A F3 Y6-9 Group
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK2340272A F1 Y3-5 Group
n=7 participants at risk
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F1 Y6-9 Group
n=13 participants at risk
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y3-5 Group
n=5 participants at risk
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
n=15 participants at risk
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
n=6 participants at risk
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
n=12 participants at risk
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
7.7%
1/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
8.3%
1/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
20.0%
1/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
6.7%
1/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
7.7%
1/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Infections and infestations
Viral infection
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
7.7%
1/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
Other adverse events
| Measure |
GSK2340272A F1 Y3-5 Group
n=7 participants at risk
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F1 Y6-9 Group
n=13 participants at risk
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y3-5 Group
n=5 participants at risk
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F2 Y6-9 Group
n=15 participants at risk
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y3-5 Group
n=6 participants at risk
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
GSK2340272A F3 Y6-9 Group
n=12 participants at risk
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
|
|---|---|---|---|---|---|---|
|
General disorders
Temperature/(Axillary)
|
28.6%
2/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
33.3%
2/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
46.2%
6/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
60.0%
9/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
66.7%
8/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
General disorders
Gastrointestinal
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
30.8%
4/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
20.0%
3/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
16.7%
2/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
General disorders
Headache
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
76.9%
10/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
60.0%
9/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
41.7%
5/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
General disorders
Loss of appetite
|
42.9%
3/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
7.7%
1/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
16.7%
1/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
General disorders
Pain
|
85.7%
6/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
100.0%
13/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
80.0%
4/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
86.7%
13/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
33.3%
2/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
50.0%
6/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
General disorders
Redness
|
71.4%
5/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
69.2%
9/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
60.0%
3/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
53.3%
8/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
50.0%
3/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
58.3%
7/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
General disorders
Swelling
|
85.7%
6/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
76.9%
10/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
40.0%
2/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
53.3%
8/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
50.0%
3/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
25.0%
3/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
General disorders
Drowsiness
|
57.1%
4/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
40.0%
2/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
50.0%
3/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
General disorders
Irritability
|
42.9%
3/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
40.0%
2/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
6.7%
1/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
8.3%
1/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
8.3%
1/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
2/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
30.8%
4/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
13.3%
2/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
66.7%
4/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
8.3%
1/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Infections and infestations
Otitis media
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
7.7%
1/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
33.3%
2/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Infections and infestations
Rhinitis
|
14.3%
1/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
40.0%
2/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
6.7%
1/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
16.7%
1/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
16.7%
2/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
30.8%
4/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
20.0%
1/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
13.3%
2/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Infections and infestations
Tracheitis
|
14.3%
1/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
20.0%
1/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
33.3%
2/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
8.3%
1/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
16.7%
1/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
|
Infections and infestations
Viral infection
|
0.00%
0/7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
7.7%
1/13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
0.00%
0/6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
8.3%
1/12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.
|
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