Trial Outcomes & Findings for Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A) (NCT NCT00964158)
NCT ID: NCT00964158
Last Updated: 2018-02-19
Results Overview
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
210 participants
Primary outcome timeframe
At Day 0
Results posted on
2018-02-19
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
GSK2340272A (3-5Y) Group
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
57
|
100
|
|
Overall Study
COMPLETED
|
53
|
56
|
92
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
8
|
Reasons for withdrawal
| Measure |
GSK2340272A (3-5Y) Group
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
6
|
Baseline Characteristics
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Baseline characteristics by cohort
| Measure |
GSK2340272A (3-5Y) Group
n=53 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (6-9Y) Group
n=57 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=100 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.5 Years
STANDARD_DEVIATION 0.7 • n=39 Participants
|
7.5 Years
STANDARD_DEVIATION 1.18 • n=41 Participants
|
13.3 Years
STANDARD_DEVIATION 2.23 • n=35 Participants
|
9.25 Years
STANDARD_DEVIATION 4.46 • n=31 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
61 Participants
n=35 Participants
|
117 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
93 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - East Asian heritage
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian/European heritage
|
53 Participants
n=39 Participants
|
56 Participants
n=41 Participants
|
99 Participants
n=35 Participants
|
208 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Unspecified
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=198 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
|
—
|
—
|
40 Participants
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=194 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
|
—
|
—
|
194 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=198 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Titers for Serum HI Antibodies
|
—
|
—
|
7.4 Titers
Interval 6.4 to 8.5
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=194 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Titers for Serum HI Antibodies
|
—
|
—
|
1538.5 Titers
Interval 1419.0 to 1668.2
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
A seroconverted subject was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=194 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
|
—
|
—
|
191 Participants
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=194 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
|
—
|
—
|
194 Participants
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=194 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibody Titers
|
—
|
—
|
208.5 Fold increase
Interval 179.0 to 242.9
|
SECONDARY outcome
Timeframe: At Days 0, 21, 42 and at Month 12Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=50 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=87 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=42 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Flu A/CAL/7/09, Day 0
|
6 Participants
|
22 Participants
|
0 Participants
|
|
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Flu A/CAL/7/09, Day 21
|
50 Participants
|
87 Participants
|
41 Participants
|
|
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Flu A/CAL/7/09, Day 42
|
49 Participants
|
83 Participants
|
41 Participants
|
|
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Flu A/CAL/7/09, Month 12
|
50 Participants
|
87 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 21, 42 and at Month 12Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=50 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=87 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=42 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Titers for Serum HI Antibodies
Flu A/CAL/7/09, Month 12
|
106.3 Titers
Interval 88.6 to 127.5
|
251.0 Titers
Interval 206.6 to 304.9
|
123.9 Titers
Interval 102.8 to 149.3
|
|
Titers for Serum HI Antibodies
Flu A/CAL/7/09, Day 0
|
6.3 Titers
Interval 5.2 to 7.7
|
8.9 Titers
Interval 6.9 to 11.3
|
5.0 Titers
Interval 5.0 to 5.0
|
|
Titers for Serum HI Antibodies
Flu A/CAL/7/09, Day 21
|
284.4 Titers
Interval 218.3 to 370.5
|
547.9 Titers
Interval 457.1 to 656.8
|
168.3 Titers
Interval 140.5 to 201.6
|
|
Titers for Serum HI Antibodies
Flu A/CAL/7/09, Day 42
|
964.6 Titers
Interval 847.4 to 1098.0
|
1008.9 Titers
Interval 881.3 to 1155.0
|
1581.1 Titers
Interval 1365.7 to 1830.6
|
SECONDARY outcome
Timeframe: At Days 21, 42 and at Month 12Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
A seroconverted subject was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=50 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=87 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=42 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Flu A/CAL/7/09, Day 21
|
50 Participants
|
85 Participants
|
41 Participants
|
|
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Flu A/CAL/7/09, Day 42
|
49 Participants
|
80 Participants
|
41 Participants
|
|
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Flu A/CAL/7/09, Month 12
|
48 Participants
|
82 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 21, 42 and at Month 12Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=50 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=87 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=42 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Seroprotected Subjects in Terms of HI Antibodies
Flu A/CAL/7/09, Day 0
|
3 Participants
|
12 Participants
|
0 Participants
|
|
Number of Seroprotected Subjects in Terms of HI Antibodies
Flu A/CAL/7/09, Day 21
|
50 Participants
|
87 Participants
|
41 Participants
|
|
Number of Seroprotected Subjects in Terms of HI Antibodies
Flu A/CAL/7/09, Day 42
|
49 Participants
|
83 Participants
|
41 Participants
|
|
Number of Seroprotected Subjects in Terms of HI Antibodies
Flu A/CAL/7/09, Month 12
|
49 Participants
|
87 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: At Days 21, 42 and at Month 12Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=50 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=87 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=42 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibody Titers
Flu A/CAL/7/09, Day 21
|
44.9 Fold increase
Interval 36.0 to 56.1
|
61.8 Fold increase
Interval 48.4 to 78.8
|
33.7 Fold increase
Interval 28.1 to 40.3
|
|
Seroconversion Factor (SCF) for HI Antibody Titers
Flu A/CAL/7/09, Day 42
|
151.7 Fold increase
Interval 123.4 to 186.5
|
119.8 Fold increase
Interval 92.3 to 155.4
|
316.2 Fold increase
Interval 273.1 to 366.1
|
|
Seroconversion Factor (SCF) for HI Antibody Titers
Flu A/CAL/7/09, Month 12
|
16.8 Fold increase
Interval 13.8 to 20.5
|
28.3 Fold increase
Interval 22.2 to 36.1
|
24.8 Fold increase
Interval 20.6 to 29.9
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=37 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=30 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=32 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Flu A/Neth/602/09, Day 0
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Flu A/Neth/602/09, Day 21
|
37 Participants
|
30 Participants
|
31 Participants
|
|
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Flu A/Neth/602/09, Day 42
|
37 Participants
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=37 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=30 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=32 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Titers for Serum Neutralizing Antibodies
Flu A/Neth/602/09, Day 0
|
6.1 Titers
Interval 4.2 to 8.8
|
5.3 Titers
Interval 3.6 to 7.9
|
4.1 Titers
Interval 3.9 to 4.4
|
|
Titers for Serum Neutralizing Antibodies
Flu A/Neth/602/09, Day 21
|
149.0 Titers
Interval 80.7 to 275.0
|
113.0 Titers
Interval 71.5 to 178.8
|
60.2 Titers
Interval 42.4 to 85.5
|
|
Titers for Serum Neutralizing Antibodies
Flu A/Neth/602/09, Day 42
|
751.0 Titers
Interval 491.0 to 1148.6
|
553.4 Titers
Interval 388.4 to 788.4
|
1277.4 Titers
Interval 895.1 to 1822.9
|
SECONDARY outcome
Timeframe: At Month 12Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=32 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=28 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=25 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
|
32 Participants
|
28 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=32 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=28 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=25 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Titers for Serum Neutralizing Antibodies
|
168.4 Titers
Interval 121.0 to 234.4
|
118.1 Titers
Interval 85.6 to 163.0
|
269.1 Titers
Interval 198.9 to 363.9
|
SECONDARY outcome
Timeframe: At Days 21 and 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=37 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=30 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=32 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Flu A/Neth/602/09, Day 21
|
32 Participants
|
26 Participants
|
26 Participants
|
|
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Flu A/Neth/602/09, Day 42
|
37 Participants
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=31 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=28 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=24 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
|
30 Participants
|
25 Participants
|
24 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 who filled in their symptom sheets.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=57 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=98 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=53 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
54 Participants
|
91 Participants
|
40 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
3 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
14 Participants
|
21 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
16 Participants
|
41 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
55 Participants
|
90 Participants
|
44 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
8 Participants
|
12 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
19 Participants
|
26 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
26 Participants
|
50 Participants
|
16 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
56 Participants
|
95 Participants
|
47 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
8 Participants
|
16 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
22 Participants
|
33 Participants
|
22 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
30 Participants
|
60 Participants
|
25 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
4 Participants
|
6 Participants
|
3 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 who filled in their symptom sheets.
Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=53 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhea, Dose 1
|
—
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhea, Dose 1
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhea, Dose 1
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1
|
—
|
—
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1
|
—
|
—
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1
|
—
|
—
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1
|
—
|
—
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1
|
—
|
—
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1
|
—
|
—
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 1
|
—
|
—
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 1
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 1
|
—
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 1
|
—
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 1
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 1
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
—
|
—
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
—
|
—
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhea, Dose 2
|
—
|
—
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhea, Dose 2
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhea, Dose 2
|
—
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2
|
—
|
—
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2
|
—
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2
|
—
|
—
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2
|
—
|
—
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2
|
—
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2
|
—
|
—
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2
|
—
|
—
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2
|
—
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2
|
—
|
—
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 2
|
—
|
—
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 2
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 2
|
—
|
—
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 2
|
—
|
—
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 2
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 2
|
—
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
—
|
—
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
—
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
—
|
—
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhea, Across doses
|
—
|
—
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhea, Across doses
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhea, Across doses
|
—
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Across doses
|
—
|
—
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Across doses
|
—
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Across doses
|
—
|
—
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across doses
|
—
|
—
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across doses
|
—
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across doses
|
—
|
—
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Across doses
|
—
|
—
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Across doses
|
—
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Across doses
|
—
|
—
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Across doses
|
—
|
—
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Across doses
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Across doses
|
—
|
—
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Across doses
|
—
|
—
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Across doses
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Across doses
|
—
|
—
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across doses
|
—
|
—
|
33 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across doses
|
—
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across doses
|
—
|
—
|
26 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 who filled in their symptom sheets.
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=98 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=57 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
47 Participants
|
—
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 2
|
25 Participants
|
—
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 2
|
8 Participants
|
—
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 2
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 2
|
7 Participants
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
16 Participants
|
—
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Across doses
|
44 Participants
|
—
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across doses
|
63 Participants
|
—
|
35 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across doses
|
59 Participants
|
—
|
34 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Across doses
|
16 Participants
|
—
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Across doses
|
1 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Across doses
|
4 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Across doses
|
53 Participants
|
—
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Across doses
|
38 Participants
|
—
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Across doses
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Across doses
|
33 Participants
|
—
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Across doses
|
14 Participants
|
—
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across doses
|
33 Participants
|
—
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across doses
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Across doses
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Across doses
|
11 Participants
|
—
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across doses
|
25 Participants
|
—
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 1
|
26 Participants
|
—
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 1
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 1
|
26 Participants
|
—
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
44 Participants
|
—
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
4 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
40 Participants
|
—
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 1
|
12 Participants
|
—
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
|
1 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
|
6 Participants
|
—
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
48 Participants
|
—
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
3 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
41 Participants
|
—
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
35 Participants
|
—
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
2 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
34 Participants
|
—
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 1
|
19 Participants
|
—
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 1
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 1
|
14 Participants
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 1
|
8 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 1
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 1
|
5 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
17 Participants
|
—
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
15 Participants
|
—
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 2
|
34 Participants
|
—
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 2
|
1 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 2
|
32 Participants
|
—
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
50 Participants
|
—
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
5 Participants
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
48 Participants
|
—
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
|
10 Participants
|
—
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
|
6 Participants
|
—
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
51 Participants
|
—
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
5 Participants
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
50 Participants
|
—
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
2 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
44 Participants
|
—
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 2
|
27 Participants
|
—
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 2
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
23 Participants
|
—
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Across doses
|
2 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Across doses
|
43 Participants
|
—
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
9 Participants
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Across doses
|
10 Participants
|
—
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across doses
|
70 Participants
|
—
|
34 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across doses
|
6 Participants
|
—
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across doses
|
64 Participants
|
—
|
34 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Across doses
|
56 Participants
|
—
|
23 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
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 (6-9Y) Group
n=57 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=100 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=53 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Any Medically-attended Events (MAEs)
|
21 Participants
|
33 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=57 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=100 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=53 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 21 and 42Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Among biochemical parameters assessed were alanine aminotransferase \[ALAT\], aspartate aminotransferase \[ASAT\], bilirubin \[BILI\], creatinine \[CREA\] and blood urea nitrogen \[BUN\]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=57 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=97 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=53 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 21 · Unknown
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 0 · Above
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 42 · Within
|
55 Participants
|
91 Participants
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 42 · Unknown
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 21 · Below
|
2 Participants
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 21 · Within
|
53 Participants
|
90 Participants
|
44 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 42 · Within
|
52 Participants
|
85 Participants
|
45 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 0 · Above
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 42 · Within
|
47 Participants
|
89 Participants
|
47 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 0 · Within
|
38 Participants
|
59 Participants
|
30 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 21 · Within
|
57 Participants
|
94 Participants
|
52 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 21 · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 42 · Unknown
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 42 · Within
|
55 Participants
|
91 Participants
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ALAT, Day 42 · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 0 · Within
|
38 Participants
|
58 Participants
|
28 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 21 · Unknown
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 21 · Within
|
56 Participants
|
94 Participants
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 21 · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 42 · Unknown
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
ASAT, Day 42 · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 0 · Within
|
38 Participants
|
57 Participants
|
30 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 0 · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 21 · Unknown
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 21 · Within
|
57 Participants
|
90 Participants
|
52 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 21 · Above
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 42 · Within
|
55 Participants
|
90 Participants
|
50 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BILI, Day 42 · Above
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 0 · Below
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 0 · Within
|
33 Participants
|
54 Participants
|
28 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 0 · Above
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 21 · Unknown
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 21 · Above
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 42 · Unknown
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 42 · Below
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
CREA, Day 42 · Above
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 0 · Within
|
37 Participants
|
57 Participants
|
28 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 21 · Unknown
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 21 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 21 · Within
|
52 Participants
|
92 Participants
|
49 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 21 · Above
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 42 · Unknown
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Normal or Abnormal Biochemical Levels
BUN, Day 42 · Above
|
8 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 21-day (Days 0-20) follow-up period after the first vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=57 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=100 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=53 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
22 Participants
|
30 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
2 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=57 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=100 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=53 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
26 Participants
|
41 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
4 Participants
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
4 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK2340272A (6-9Y) Group
n=57 Participants
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=100 Participants
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (3-5Y) Group
n=53 Participants
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
GSK2340272A (3-5Y) Group
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
GSK2340272A (6-9Y) Group
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
GSK2340272A (10-17Y) Group
Serious events: 1 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK2340272A (3-5Y) Group
n=53 participants at risk
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (6-9Y) Group
n=57 participants at risk
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=100 participants at risk
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/53 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/57 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
1.0%
1/100 • Number of events 1 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
Other adverse events
| Measure |
GSK2340272A (3-5Y) Group
n=53 participants at risk
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (6-9Y) Group
n=57 participants at risk
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
GSK2340272A (10-17Y) Group
n=100 participants at risk
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/53 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
35.1%
20/57 • Number of events 23 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
44.0%
44/100 • Number of events 60 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
General disorders
Chills
|
20.8%
11/53 • Number of events 11 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
33.3%
19/57 • Number of events 21 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
38.0%
38/100 • Number of events 47 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
5/53 • Number of events 9 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
5.3%
3/57 • Number of events 3 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
4.0%
4/100 • Number of events 4 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
52.8%
28/53 • Number of events 35 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
1.8%
1/57 • Number of events 1 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/100 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Diarrhoea
|
15.1%
8/53 • Number of events 9 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/57 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/100 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Ear infection
|
7.5%
4/53 • Number of events 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/57 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/100 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
41.5%
22/53 • Number of events 33 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
38.6%
22/57 • Number of events 33 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
33.0%
33/100 • Number of events 47 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
General disorders
Fatigue
|
0.00%
0/53 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
61.4%
35/57 • Number of events 50 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
63.0%
63/100 • Number of events 95 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Gastroenteritis
|
7.5%
4/53 • Number of events 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
1.8%
1/57 • Number of events 1 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
3.0%
3/100 • Number of events 3 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/53 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
29.8%
17/57 • Number of events 22 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
16.0%
16/100 • Number of events 23 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Nervous system disorders
Headache
|
5.7%
3/53 • Number of events 3 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
59.6%
34/57 • Number of events 51 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
71.0%
71/100 • Number of events 105 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
18.9%
10/53 • Number of events 10 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
15.8%
9/57 • Number of events 9 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
14.0%
14/100 • Number of events 16 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Psychiatric disorders
Irritability
|
39.6%
21/53 • Number of events 29 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/57 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/100 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Laryngitis
|
11.3%
6/53 • Number of events 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
3.5%
2/57 • Number of events 2 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
1.0%
1/100 • Number of events 1 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/53 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
40.4%
23/57 • Number of events 31 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
56.0%
56/100 • Number of events 82 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/53 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
5.3%
3/57 • Number of events 3 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
1.0%
1/100 • Number of events 1 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/53 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
5.3%
3/57 • Number of events 3 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/100 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Otitis media
|
5.7%
3/53 • Number of events 3 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/57 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/100 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
General disorders
Pain
|
88.7%
47/53 • Number of events 85 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
98.2%
56/57 • Number of events 109 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
95.0%
95/100 • Number of events 181 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Pharyngitis
|
9.4%
5/53 • Number of events 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
1.8%
1/57 • Number of events 1 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
1.0%
1/100 • Number of events 1 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
General disorders
Pyrexia
|
64.2%
34/53 • Number of events 44 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
49.1%
28/57 • Number of events 34 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
34.0%
34/100 • Number of events 41 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Nervous system disorders
Somnolence
|
41.5%
22/53 • Number of events 28 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/57 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/100 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
General disorders
Swelling
|
47.2%
25/53 • Number of events 34 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
52.6%
30/57 • Number of events 42 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
60.0%
60/100 • Number of events 91 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Tonsillitis
|
5.7%
3/53 • Number of events 3 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
1.8%
1/57 • Number of events 1 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
6.0%
6/100 • Number of events 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Upper respiratory tract infection
|
20.8%
11/53 • Number of events 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
5.3%
3/57 • Number of events 3 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
14.0%
14/100 • Number of events 19 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
3/53 • Number of events 3 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
1.8%
1/57 • Number of events 1 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
|
0.00%
0/100 • 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) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 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