Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children (NCT NCT00972517)
NCT ID: NCT00972517
Last Updated: 2019-06-26
Results Overview
Antibody titers were expressed as Geometric mean titers (GMTs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
245 participants
Primary outcome timeframe
At Day 0, Day 21 and Day 42
Results posted on
2019-06-26
Participant Flow
One subject was enrolled but not vaccinated and therefore, was not included in the number of subjects under "STARTED"
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 |
Flu BS1_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
60
|
30
|
34
|
58
|
|
Overall Study
COMPLETED
|
31
|
30
|
60
|
27
|
33
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Flu BS1_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
Baseline characteristics by cohort
| Measure |
Group A
n=244 Participants
Subjects receiving alternative dose of GSK23440272A vaccine
|
|---|---|
|
Age, Continuous
|
9.2 Years
STANDARD_DEVIATION 4.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 0, Day 21 and Day 42Population: The ATP cohort for immunogenicity included all subjects for whom 2 doses were administrated and assay results were available for the blood samples taken before the first vaccination (Day 0), before the second vaccination (Day 21) and after the second vaccine dose (Day 42). No blood samples were planned at Day 0 and Day 21 for Flu BS2 Groups.
Antibody titers were expressed as Geometric mean titers (GMTs).
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=54 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=28 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=30 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=25 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=30 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=57 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
H1N1, Day 0
|
9.9 Titers
Interval 7.0 to 14.1
|
5.7 Titers
Interval 4.5 to 7.2
|
5.2 Titers
Interval 4.8 to 5.8
|
—
|
—
|
—
|
|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
H1N1, Day 21
|
479.3 Titers
Interval 361.8 to 634.9
|
192.6 Titers
Interval 145.6 to 254.8
|
190.3 Titers
Interval 147.0 to 246.3
|
—
|
—
|
—
|
|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
H1N1, Day 42
|
1069.4 Titers
Interval 892.6 to 1281.3
|
1361.7 Titers
Interval 1107.0 to 1674.9
|
970.1 Titers
Interval 765.8 to 1228.8
|
1161.7 Titers
Interval 905.2 to 1490.9
|
915.7 Titers
Interval 759.1 to 1104.6
|
979.6 Titers
Interval 845.3 to 1135.2
|
PRIMARY outcome
Timeframe: At Day 42Population: This measure was assessed on the ATP cohort for immunogenicity on subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, seroconversion at Day 42 could not be computed for those groups.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (\<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (\>) 40% in children aged 3 to 17 years.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=54 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=28 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=30 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
|
53 Participants
|
28 Participants
|
30 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The ATP cohort for immunogenicity included all evaluable subjects for whom 2 doses were administrated and assay results were available for antibodies against H1N1 antigen for the blood sample taken after the second vaccine dose (Day 42).
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (\>) 70% in children aged 3 to 17 years.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=54 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=28 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=30 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=25 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=30 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=57 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
|
54 Participants
|
28 Participants
|
30 Participants
|
25 Participants
|
30 Participants
|
57 Participants
|
PRIMARY outcome
Timeframe: At Day 42Population: This measure was assessed on the ATP cohort for immunogenicity on subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, GMFR at Day 42 could not be computed for those groups.
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (\>) 2.5 in children aged 3 to 17 years
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=54 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=28 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=30 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
|
107.74 Fold change
Interval 76.64 to 151.45
|
237.68 Fold change
Interval 175.28 to 322.29
|
185.25 Fold change
Interval 142.09 to 241.52
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 6Population: The ATP cohort for antibody persistence at Month 6 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for antibodies against the study vaccine antigen component at Month 6.
Antibody titers were expressed as geometric mean titers (GMTs)
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=53 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=27 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=28 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=23 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=27 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=47 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
|
254.6 Titers
Interval 199.0 to 325.7
|
140.8 Titers
Interval 118.2 to 167.6
|
154.2 Titers
Interval 126.5 to 187.9
|
129.4 Titers
Interval 94.6 to 176.9
|
148.2 Titers
Interval 119.0 to 184.4
|
243.6 Titers
Interval 185.9 to 319.3
|
SECONDARY outcome
Timeframe: At Month 12Population: The ATP cohort for antibody persistence at Month 12 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12. As no blood samples were planned at Month 12 for the Flu BS1 Groups, GMTs could not be computed for those groups.
Antibody titers were expressed as geometric mean titers (GMTs)
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=41 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=20 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=26 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
|
132.8 Titers
Interval 94.9 to 185.8
|
48.5 Titers
Interval 35.7 to 65.7
|
60.5 Titers
Interval 49.2 to 74.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 6Population: The ATP cohort for antibody persistence at Month 6 including all evaluable subjects for whom assay results were available at pre-vaccination time points (Day 0 and Day 21) and post-vaccination time point (Month 6). No pre-vaccination blood samples were taken from Flu BS2 Groups and hence seroconversion could not be assessed for these groups.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (\<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (\>) 40% in children aged 3 to 17 years.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=53 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=27 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=28 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
|
50 Participants
|
27 Participants
|
28 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 6Population: The ATP cohort for antibody persistence at Month 6 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (\>) 70% in children aged 3 to 17 years.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=53 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=27 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=28 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=23 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=27 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=47 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
|
53 Participants
|
27 Participants
|
28 Participants
|
20 Participants
|
27 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: The ATP cohort for antibody persistence at Month 12 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12. As no blood samples were planned at Month 12 for the Flu BS1 Groups, no data were computed for these groups.
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (\>) 70% in children aged 3 to 17 years.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=41 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=20 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=26 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
|
37 Participants
|
17 Participants
|
22 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 6Population: The ATP cohort for antibody persistence at Month 6 including all subjects for whom assay results were available for antibodies against the study vaccine antigen component pre-vaccination (Day 0 and Day 21) and at Month 6. As no pre-vaccination blood samples were planned for the Flu BS2 Groups, GMFR at Month 6 could not be computed for those groups.
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (\>) 2.5 in children aged 3 to 17 years
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=53 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=27 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=28 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
|
25.32 Fold change
Interval 18.6 to 34.47
|
27.44 Fold change
Interval 22.42 to 33.57
|
29.35 Fold change
Interval 23.53 to 36.61
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42 and Month 6Population: The ATP cohort for immunogenicity including all evaluable subjects for whom assay results were available at the considered time points. No blood samples were taken at Day 0 and Day 21 and hence no GMTs computed for the Flu BS2 Groups. This analysis was conducted on a randomly selected subset of one third of the subjects.
Antibody titers were expressed as Geometric mean titers (GMTs).
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=14 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=16 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=15 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=12 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=13 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=15 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
H1N1, Day 0
|
8 Titers
Interval 3.0 to 21.3
|
4.9 Titers
Interval 3.9 to 6.1
|
7.1 Titers
Interval 3.9 to 12.7
|
—
|
—
|
—
|
|
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
H1N1, Day 21
|
109.4 Titers
Interval 34.5 to 346.7
|
27.7 Titers
Interval 13.0 to 58.8
|
65.9 Titers
Interval 24.6 to 176.4
|
—
|
—
|
—
|
|
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
H1N1, Day 42
|
438.4 Titers
Interval 191.3 to 1004.8
|
433.2 Titers
Interval 295.2 to 635.6
|
473.7 Titers
Interval 301.5 to 744.1
|
533.4 Titers
Interval 298.4 to 953.7
|
260.1 Titers
Interval 141.9 to 476.6
|
199.5 Titers
Interval 112.7 to 353.2
|
|
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
H1N1, Month 6
|
232.1 Titers
Interval 81.8 to 658.4
|
158.9 Titers
Interval 110.4 to 228.8
|
203.3 Titers
Interval 133.7 to 309.3
|
156.6 Titers
Interval 89.8 to 273.3
|
166 Titers
Interval 88.7 to 310.6
|
150.9 Titers
Interval 62.7 to 363.1
|
SECONDARY outcome
Timeframe: At Month 12Population: The ATP cohort for immunogenicity including all evaluable subjects for whom assay results were available at Month 12. No blood samples were planned at Month 12 the Flu BS1 Groups and hence no GMTs computed for these Groups. This analysis was conducted on a randomly selected subset of one third of the subjects.
Antibody titers were expressed as Geometric mean titers (GMTs).
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=12 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=11 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=12 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
|
138.3 Titers
Interval 71.6 to 267.2
|
152.3 Titers
Interval 88.8 to 261.0
|
129.9 Titers
Interval 71.2 to 236.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21 and Day 42Population: The ATP cohort for immunogenicity including subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, seroconversion could not be computed for those groups. This analysis was conducted on a randomly selected subset of one third of the subjects.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (\<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (\>) 40% in children aged 3 to 17 years.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=14 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=16 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=15 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
H1N1, Day 21
|
9 Participants
|
8 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
H1N1, Day 42
|
14 Participants
|
15 Participants
|
15 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 6Population: The ATP cohort for antibody persistence at Month 6 including subjects with assay results available for Day 0, Day 21 and Month 6. As no pre-vaccination (Day 0/21) blood samples were planned for the Flu BS2 Groups, seroconversion could not be computed for those groups. This analysis was done on a randomly selected subset of a third of the subjects.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (\<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (\>) 40% in children aged 3 to 17 years.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=13 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=16 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=15 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
|
12 Participants
|
16 Participants
|
14 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The Total Vaccinated cohort including all vaccinated subjects who returned their symptom sheet.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. \> 50mm.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=118 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=60 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=65 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain
|
96 Participants
|
40 Participants
|
49 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
11 Participants
|
4 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness
|
46 Participants
|
28 Participants
|
28 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
46 Participants
|
22 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
10 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The Total Vaccinated cohort including all vaccinated subjects who returned their symptom sheet.
Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever \[axillary temperature above 37.5 degrees Celsius (°C)\]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=118 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=60 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=65 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
61 Participants
|
0 Participants
|
19 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia
|
45 Participants
|
0 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (>39°C)
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia
|
25 Participants
|
0 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia
|
23 Participants
|
0 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhoea
|
0 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhoea
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhoea
|
0 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
0 Participants
|
20 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
0 Participants
|
18 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
53 Participants
|
0 Participants
|
24 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
6 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
50 Participants
|
0 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Gastro-intestinal symptoms
|
30 Participants
|
0 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastro-intestinal symptoms
|
5 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Gastro-intestinal symptoms
|
23 Participants
|
0 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
10 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
56 Participants
|
0 Participants
|
19 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability
|
0 Participants
|
18 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability
|
0 Participants
|
18 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite
|
0 Participants
|
18 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite
|
0 Participants
|
17 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia
|
43 Participants
|
0 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Shivering
|
35 Participants
|
10 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Shivering
|
33 Participants
|
9 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Sweating
|
18 Participants
|
9 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Sweating
|
15 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever (≥37.5°C)
|
30 Participants
|
27 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
23 Participants
|
23 Participants
|
11 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Month 12)Population: The Total Vaccinated cohort included all vaccinated subjects.
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=60 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=31 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=31 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=30 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=34 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=58 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
|
36 Participants
|
22 Participants
|
19 Participants
|
24 Participants
|
16 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Month 12)Population: The Total Vaccinated cohort included all vaccinated subjects.
Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune etiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=118 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=61 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=65 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects.
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=118 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=61 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=65 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Any AE(s)
|
53 Participants
|
42 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Grade 3 AE(s)
|
5 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Related AE(s)
|
4 Participants
|
9 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Month 12)Population: The Total Vaccinated cohort included all vaccinated subjects.
A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=60 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=31 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=31 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=30 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=34 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=58 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 21, Day 42 and Month 6 (M6)Population: The Total Vaccinated cohort including all vaccinated subjects with data available for the respective assays at the considered timepoints. Note that for Flu BS2 Groups, no blood samples were taken at Day 0 and Day 21 and hence no data for these timepoints are reported for the Flu BS2 Groups.
Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown as measured by validated assay according to international standards.
Outcome measures
| Measure |
Flu BS1_10-17 Years Group
n=60 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_3-5 Years Group
n=31 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=31 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=26 Participants
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=33 Participants
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=58 Participants
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, M6 Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, M6 Within
|
57 Participants
|
30 Participants
|
28 Participants
|
24 Participants
|
29 Participants
|
50 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 0 Within
|
57 Participants
|
29 Participants
|
28 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 21 Above
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 42 Within
|
55 Participants
|
29 Participants
|
28 Participants
|
23 Participants
|
32 Participants
|
56 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, M6 Below
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, M6 Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 21 Within
|
58 Participants
|
30 Participants
|
29 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, M6 Within
|
55 Participants
|
28 Participants
|
28 Participants
|
22 Participants
|
29 Participants
|
47 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 0 Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 0 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 0 Within
|
58 Participants
|
29 Participants
|
30 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 21 Above
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 0 Above
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 21 Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 21 Above
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 42 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 42 Within
|
55 Participants
|
31 Participants
|
29 Participants
|
25 Participants
|
31 Participants
|
55 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 42 Above
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, M6 Above
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 0 Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, M6 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, M6 Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 0 Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 0 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 0 Above
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 21 Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 21 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 21 Within
|
55 Participants
|
30 Participants
|
28 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 21 Above
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 42 Unknown
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 42 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 42 Within
|
55 Participants
|
31 Participants
|
30 Participants
|
26 Participants
|
33 Participants
|
55 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, Day 42 Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, M6 Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, M6 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, M6 Within
|
55 Participants
|
30 Participants
|
28 Participants
|
24 Participants
|
29 Participants
|
51 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Total Bilirubin, M6 Above
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 0 Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 0 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 0 Within
|
58 Participants
|
29 Participants
|
30 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 0 Above
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 21 Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 21 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 21 Within
|
58 Participants
|
30 Participants
|
30 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 42 Unknown
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 42 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 42 Within
|
56 Participants
|
31 Participants
|
30 Participants
|
26 Participants
|
33 Participants
|
57 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 0 Below
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 0 Within
|
52 Participants
|
27 Participants
|
29 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 0 Above
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 21 Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 21 Below
|
4 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 21 Within
|
48 Participants
|
27 Participants
|
28 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 21 Above
|
6 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 42 Unknown
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 42 Below
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 42 Within
|
52 Participants
|
28 Participants
|
29 Participants
|
24 Participants
|
31 Participants
|
51 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, Day 42 Above
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, M6 Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, M6 Below
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Creatine, M6 Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 0 Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 0 Below
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 0 Within
|
57 Participants
|
28 Participants
|
30 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 0 Above
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 21 Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 21 Below
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 21 Within
|
55 Participants
|
29 Participants
|
27 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 21 Above
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 42 Unknown
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 42 Below
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, Day 42 Above
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
BUN, M6 Within
|
54 Participants
|
27 Participants
|
28 Participants
|
24 Participants
|
27 Participants
|
53 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, Day 42 Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, M6 Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, M6 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, M6 Within
|
57 Participants
|
30 Participants
|
29 Participants
|
24 Participants
|
29 Participants
|
53 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Bilirubin Conjugated / Direct, M6 Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 21 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 42 Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 0 Above
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 21 Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 21 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 21 Within
|
58 Participants
|
30 Participants
|
30 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 42 Unknown
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 42 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 42 Within
|
55 Participants
|
31 Participants
|
30 Participants
|
26 Participants
|
32 Participants
|
56 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, Day 42 Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, M6 Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, M6 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, M6 Within
|
56 Participants
|
30 Participants
|
29 Participants
|
24 Participants
|
29 Participants
|
52 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ALAT, M6 Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 0 Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 0 Below
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
ASAT, Day 0 Within
|
58 Participants
|
26 Participants
|
29 Participants
|
—
|
—
|
—
|
Adverse Events
Flu BS1_3-5 Years Group
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Flu BS1_6-9 Years Group
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Flu BS1_10-17 Years Group
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Flu BS2_3-5 Years Group
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Flu BS2_6-9 Years Group
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Flu BS2_10-17 Years Group
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flu BS1_3-5 Years Group
n=31 participants at risk
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=31 participants at risk
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_10-17 Years Group
n=60 participants at risk
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=30 participants at risk
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=34 participants at risk
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=58 participants at risk
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Haematoma
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.3%
1/30 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/58 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/60 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/58 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Gastrointestinal disorders
Ranula
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/58 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.3%
1/30 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
Other adverse events
| Measure |
Flu BS1_3-5 Years Group
n=31 participants at risk
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_6-9 Years Group
n=31 participants at risk
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS1_10-17 Years Group
n=60 participants at risk
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
|
Flu BS2_3-5 Years Group
n=30 participants at risk
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_6-9 Years Group
n=34 participants at risk
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
Flu BS2_10-17 Years Group
n=58 participants at risk
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
22.6%
7/31 • Number of events 10 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
18.3%
11/60 • Number of events 14 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
6.7%
2/30 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
20.6%
7/34 • Number of events 9 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
24.1%
14/58 • Number of events 17 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Bronchitis
|
6.5%
2/31 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.3%
2/60 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
13.3%
4/30 • Number of events 5 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/58 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
General disorders
Chills
|
22.6%
7/31 • Number of events 11 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
22.6%
7/31 • Number of events 8 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
30.0%
18/60 • Number of events 24 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
10.0%
3/30 • Number of events 4 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
8.8%
3/34 • Number of events 4 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
29.3%
17/58 • Number of events 22 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Eye disorders
Conjunctivitis
|
9.7%
3/31 • Number of events 3 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.3%
1/30 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/58 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
5/31 • Number of events 7 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
16.7%
5/30 • Number of events 10 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
5.9%
2/34 • Number of events 3 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.4%
2/58 • Number of events 3 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.3%
10/31 • Number of events 12 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/60 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
30.0%
9/30 • Number of events 13 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.4%
6/31 • Number of events 7 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
13.3%
4/30 • Number of events 5 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.5%
2/31 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
45.2%
14/31 • Number of events 18 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
51.6%
16/31 • Number of events 20 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
38.3%
23/60 • Number of events 34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
46.7%
14/30 • Number of events 21 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
35.3%
12/34 • Number of events 16 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
39.7%
23/58 • Number of events 30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
General disorders
Fatigue
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
41.9%
13/31 • Number of events 18 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
48.3%
29/60 • Number of events 37 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
32.4%
11/34 • Number of events 15 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
41.4%
24/58 • Number of events 36 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Gastroenteritis
|
6.5%
2/31 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
6.7%
2/30 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/58 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
22.6%
7/31 • Number of events 11 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
30.0%
18/60 • Number of events 21 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
17.6%
6/34 • Number of events 7 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
20.7%
12/58 • Number of events 13 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
29.0%
9/31 • Number of events 14 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
50.0%
30/60 • Number of events 47 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
13.3%
4/30 • Number of events 4 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
29.4%
10/34 • Number of events 13 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
53.4%
31/58 • Number of events 50 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.9%
4/31 • Number of events 4 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
12.9%
4/31 • Number of events 4 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
15.0%
9/60 • Number of events 10 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
16.7%
5/30 • Number of events 6 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
17.6%
6/34 • Number of events 6 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
15.5%
9/58 • Number of events 10 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
General disorders
Influenza like illness
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.3%
2/60 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.3%
1/30 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
6.9%
4/58 • Number of events 4 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Psychiatric disorders
Irritability
|
29.0%
9/31 • Number of events 13 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
30.0%
9/30 • Number of events 14 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Lice infestation
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
6.7%
2/30 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
2.9%
1/34 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/58 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
19.4%
6/31 • Number of events 10 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
35.0%
21/60 • Number of events 26 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.3%
1/30 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
20.6%
7/34 • Number of events 12 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
41.4%
24/58 • Number of events 29 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
2/31 • Number of events 3 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
5.0%
3/60 • Number of events 4 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
13.3%
4/30 • Number of events 6 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
5.9%
2/34 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
6.9%
4/58 • Number of events 5 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Otitis externa
|
6.5%
2/31 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/60 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/58 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Otitis media
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/60 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
6.7%
2/30 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
General disorders
Pain
|
61.3%
19/31 • Number of events 29 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
77.4%
24/31 • Number of events 40 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
85.0%
51/60 • Number of events 92 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
70.0%
21/30 • Number of events 38 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
73.5%
25/34 • Number of events 42 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
77.6%
45/58 • Number of events 75 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
6.5%
2/31 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/30 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
General disorders
Pyrexia
|
48.4%
15/31 • Number of events 22 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
22.6%
7/31 • Number of events 10 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
31.7%
19/60 • Number of events 22 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
50.0%
15/30 • Number of events 22 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
26.5%
9/34 • Number of events 11 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
20.7%
12/58 • Number of events 14 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Rhinitis
|
9.7%
3/31 • Number of events 3 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.2%
1/31 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.3%
2/60 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
6.7%
2/30 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
2.9%
1/34 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/58 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Nervous system disorders
Somnolence
|
35.5%
11/31 • Number of events 16 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/31 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/60 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
30.0%
9/30 • Number of events 11 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/58 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
General disorders
Swelling
|
41.9%
13/31 • Number of events 16 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
41.9%
13/31 • Number of events 18 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
35.0%
21/60 • Number of events 28 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
30.0%
9/30 • Number of events 13 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
26.5%
9/34 • Number of events 13 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
43.1%
25/58 • Number of events 38 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.9%
4/31 • Number of events 4 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.2%
1/31 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
8.3%
5/60 • Number of events 5 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
13.3%
4/30 • Number of events 5 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.4%
2/58 • Number of events 3 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
|
Infections and infestations
Viral infection
|
6.5%
2/31 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
6.5%
2/31 • Number of events 2 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
1.7%
1/60 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
3.3%
1/30 • Number of events 1 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
0.00%
0/34 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
5.2%
3/58 • Number of events 3 • SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
|
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