Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children (NCT NCT01379937)
NCT ID: NCT01379937
Last Updated: 2018-09-07
Results Overview
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
520 participants
Primary outcome timeframe
At Day 192.
Results posted on
2018-09-07
Participant Flow
The study was of an overall duration 364 days for all subjects.
Participant milestones
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
156
|
156
|
104
|
104
|
|
Overall Study
COMPLETED
|
155
|
153
|
102
|
103
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Consent withdrawal
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children
Baseline characteristics by cohort
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Total
n=520 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
9.70 Years
STANDARD_DEVIATION 4.26 • n=5 Participants
|
9.40 Years
STANDARD_DEVIATION 3.88 • n=7 Participants
|
9.3 Years
STANDARD_DEVIATION 3.87 • n=5 Participants
|
9.6 Years
STANDARD_DEVIATION 4.23 • n=4 Participants
|
9.51 Years
STANDARD_DEVIATION 4.06 • n=21 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
266 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
254 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Day 192.Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=127 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=84 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.
|
737.6 Titer
Interval 646.8 to 841.1
|
24.7 Titer
Interval 19.7 to 31.0
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 0 to Day 182Population: The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.
Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=312 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=208 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Any Medically Attended Adverse Events (MAEs)
|
115 Subjects
|
64 Subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 0 to Day 364.Population: The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.
Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Any Medically Attended Adverse Events (MAEs)
|
65 Subjects
|
84 Subjects
|
41 Subjects
|
41 Subjects
|
SECONDARY outcome
Timeframe: At Days 0, 42, 182, 192, 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
The antibody titres were given as Geometric Mean Titer (GMT). A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=155 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=152 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=103 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=101 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO, Day 0 [N=155,152,103,101]
|
5.7 Titer
Interval 5.4 to 6.0
|
5.5 Titer
Interval 5.2 to 5.8
|
5.4 Titer
Interval 5.1 to 5.8
|
5.8 Titer
Interval 5.3 to 6.3
|
|
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO, Day 42 [N=155,152,103,101]
|
553.5 Titer
Interval 490.9 to 624.1
|
595.0 Titer
Interval 522.1 to 678.2
|
5.6 Titer
Interval 5.2 to 6.0
|
6.2 Titer
Interval 5.6 to 7.0
|
|
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO, Day 182 [N=155,152,103,101]
|
52.2 Titer
Interval 47.7 to 57.1
|
54.1 Titer
Interval 49.5 to 59.1
|
5.1 Titer
Interval 5.0 to 5.2
|
5.6 Titer
Interval 5.3 to 6.0
|
|
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO, Day 192 [N=127,NA,45,NA]
|
674.1 Titer
Interval 595.0 to 763.8
|
NA Titer
For D192 , antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
7.6 Titer
Interval 6.7 to 8.5
|
NA Titer
For D192 , antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
|
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO, Day 364 [N=151,147,100,NA]
|
205.5 Titer
Interval 183.3 to 230.4
|
40.4 Titer
Interval 36.8 to 44.5
|
8.5 Titer
Interval 7.6 to 9.4
|
NA Titer
For D364, antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
|
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/TURK, Day 0 [N=155,152,103,101]
|
7.0 Titer
Interval 6.3 to 7.7
|
6.4 Titer
Interval 5.9 to 7.0
|
6.1 Titer
Interval 5.6 to 6.8
|
7.2 Titer
Interval 6.3 to 8.2
|
|
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/TURK, Day 42 [N=155,152,103,101]
|
193.0 Titer
Interval 172.1 to 216.5
|
240.3 Titer
Interval 188.1 to 240.3
|
6.9 Titer
Interval 6.9 to 7.9
|
8.5 Titer
Interval 7.2 to 10.0
|
|
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/TURK, Day 182 [N=127,152,84,101]
|
39.6 Titer
Interval 35.8 to 43.8
|
42.5 Titer
Interval 38.9 to 46.4
|
6.0 Titer
Interval 5.5 to 6.5
|
7.0 Titer
Interval 6.1 to 8.0
|
|
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/TURK, Day 364 [N=151,147,100,NA]
|
215.1 Titer
Interval 190.3 to 243.3
|
35.4 Titer
Interval 32.2 to 39.0
|
18.4 Titer
Interval 16.3 to 20.9
|
NA Titer
For D364, antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
SECONDARY outcome
Timeframe: At Days 0, 42, 182, 192, 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
Antibody titers were given as GMTs. A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=151 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=147 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=100 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=102 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/TURK, Day 42, [N=150,146,98,100]
|
155.7 Titer
Interval 141.9 to 171.0
|
162.7 Titer
Interval 147.8 to 179.2
|
16.0 Titer
Interval 14.7 to 17.5
|
17.6 Titer
Interval 15.9 to 19.5
|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO, Day 0 [N=149,145,98,99]
|
16.6 Titer
Interval 15.4 to 17.9
|
16.0 Titer
Interval 15.0 to 17.0
|
15.3 Titer
Interval 14.4 to 16.3
|
16.0 Titer
Interval 14.9 to 17.3
|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO,Day 42 [N=150,146,99,100]
|
726.8 Titer
Interval 646.1 to 817.6
|
804.1 Titer
Interval 710.8 to 909.5
|
15.3 Titer
Interval 14.4 to 16.4
|
17.0 Titer
Interval 15.1 to 19.1
|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO, Day 182 [N=151,147,100,102]
|
133.3 Titer
Interval 125.2 to 142.0
|
140.7 Titer
Interval 132.1 to 149.8
|
15.0 Titer
Interval 14.2 to 15.8
|
14.7 Titer
Interval 14.0 to 15.5
|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/TURK, Day 364, [N=149,145,98,NA]
|
415.2 Titer
Interval 359.2 to 479.9
|
99.9 Titer
Interval 92.6 to 107.9
|
67.1 Titer
Interval 59.6 to 75.5
|
NA Titer
For D364, antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO, Day 192 [N=149,NA,99,NA]
|
2128.0 Titer
Interval 1864.0 to 2429.5
|
NA Titer
For D192 , antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
38.6 Titer
Interval 33.7 to 44.1
|
NA Titer
For D192 , antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/INDO, Day 364 [N=149,147,100,NA]
|
523.1 Titer
Interval 452.9 to 604.2
|
132.7 Titer
Interval 123.9 to 142.2
|
30.4 Titer
Interval 26.8 to 34.4
|
NA Titer
For D364, antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/TURK, Day 0, [N=149,145,98,100]
|
16.4 Titer
Interval 15.3 to 17.6
|
15.9 Titer
Interval 15.0 to 16.9
|
15.6 Titer
Interval 14.5 to 16.8
|
17.3 Titer
Interval 15.8 to 19.0
|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/TURK, Day 182, [N=151,147,100,101]
|
85.3 Titer
Interval 79.7 to 91.2
|
85.1 Titer
Interval 79.2 to 91.3
|
15.7 Titer
Interval 14.6 to 16.8
|
15.5 Titer
Interval 14.5 to 16.5
|
|
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
A/TURK, Day 192, [N=150,NA,100,NA]
|
1420.4 Titer
Interval 1229.6 to 1640.8
|
NA Titer
For D192 , antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
68.3 Titer
Interval 58.2 to 80.2
|
NA Titer
For D192 , antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
|
SECONDARY outcome
Timeframe: During a 7-day (Day 0-6) follow-up period after each vaccinationPopulation: The analysis was based on the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Swelling, Across [N=156,156,104,104]
|
15 Subjects
|
13 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Pain, D1 [N=156,156,104,104]
|
106 Subjects
|
112 Subjects
|
45 Subjects
|
43 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Pain, D1 [N=156,156,104,104]
|
2 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Redness, D1 [N=156,156,104,104]
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Redness, D1 [N=156,156,104,104]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Swelling, D1 [N=156,156,104,104]
|
9 Subjects
|
9 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Swelling, D1 [N=156,156,104,104]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Pain, D2 [N=156,156,104,103]
|
93 Subjects
|
103 Subjects
|
65 Subjects
|
29 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Pain, D2 [N=156,156,104,103]
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Redness, D2 [N=156,156,104,103]
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Redness, D2 [N=156,156,104,103]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Swelling, D2 [N=156,156,104,103]
|
7 Subjects
|
7 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Swelling, D2 [N=156,156,104,103]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Pain, D3 [N=156,154,0,0]
|
105 Subjects
|
52 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Pain, D3 [N=156,154,0,0]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Redness, D3 [N=156,154,0,0]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Redness, D3 [N=156,154,0,0]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Swelling, D3 [N=156,154,0,0]
|
4 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Swelling, D3 [N=156,1540,0]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Pain, Across [N=156,156,104,104]
|
127 Subjects
|
129 Subjects
|
73 Subjects
|
53 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Pain, Across [N=156,156,104,104]
|
5 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Redness, Across [N=156,156,104,104]
|
4 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Redness, Across [N=156,156,104,104]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Swelling, Across [N=156,156,104,104]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day (Day 0-6) follow-up period after each vaccinationPopulation: The analysis was based on subjects aged less than 6 years, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Assessed solicited general symptoms were diarrhea/vomiting, drowsiness, irritability/fussiness, loss of appetite and temperature \[defined as axillary temperature equal to or above 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged less than 6 years.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=30 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=31 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=22 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=24 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any diarrhoea/vomiting
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 diarrhoea/vomiting
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related diarrhoea/vomiting
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any drowsiness
|
5 Subjects
|
8 Subjects
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 drowsiness
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related drowsiness
|
5 Subjects
|
8 Subjects
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any irritability / fussiness
|
8 Subjects
|
10 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 irritability / fussiness
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related irritability / fussiness
|
8 Subjects
|
10 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any loss of appetite
|
8 Subjects
|
9 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 loss of appetite
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related loss of appetite
|
8 Subjects
|
8 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any temperature
|
12 Subjects
|
11 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 temperature
|
2 Subjects
|
4 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related temperature
|
11 Subjects
|
10 Subjects
|
1 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day (Day 0-6) follow-up period after vaccinationPopulation: The analysis was based on subjects aged 6 years or more, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia and temperature\[defined as axillary temperature equal to or above 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged 6 years or more.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=126 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=125 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=82 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=80 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Arthralgia, D1 [N=126,125,82,80]
|
13 Subjects
|
20 Subjects
|
7 Subjects
|
8 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Arthralgia, D1 [N=126,125,82,80]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Arthralgia, D1 [N=126,125,82,80]
|
12 Subjects
|
19 Subjects
|
7 Subjects
|
7 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, D1 [N=126,125,82,80]
|
16 Subjects
|
16 Subjects
|
8 Subjects
|
8 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, D1 [N=126,125,82,80]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, D1 [N=126,125,82,80]
|
15 Subjects
|
16 Subjects
|
8 Subjects
|
7 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms,D1 [N=126,125,82,80]
|
9 Subjects
|
5 Subjects
|
6 Subjects
|
7 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal ,D1 [N=126,125,82,80]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal ,D1 [N=126,125,82,80]
|
7 Subjects
|
5 Subjects
|
6 Subjects
|
6 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, D1 [N=126,125,82,80]
|
31 Subjects
|
24 Subjects
|
14 Subjects
|
19 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, D1 [N=126,125,82,80]
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, D1 [N=126,125,82,80]
|
30 Subjects
|
23 Subjects
|
12 Subjects
|
17 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, D1 [N=126,125,82,80]
|
14 Subjects
|
23 Subjects
|
8 Subjects
|
11 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, D1 [N=126,125,82,80]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, D1 [N=126,125,82,80]
|
14 Subjects
|
22 Subjects
|
8 Subjects
|
10 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature/(Axillary), D1 [N=126,125,82,80]
|
10 Subjects
|
2 Subjects
|
6 Subjects
|
7 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature/(Axillary),D1[N=126,125,82,80]
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature/(Axillary),D1[N=126,125,82,80]
|
8 Subjects
|
1 Subjects
|
3 Subjects
|
5 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Arthralgia, D2 [N=126,125,82,79]
|
11 Subjects
|
18 Subjects
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Arthralgia, D2 [N=126,125,82,79]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Arthralgia, D2 [N=126,125,82,79]
|
11 Subjects
|
18 Subjects
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, D2 [N=126,125,82,79]
|
12 Subjects
|
7 Subjects
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, D2 [N=126,125,82,79]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, D2 [N=126,125,82,79]
|
12 Subjects
|
7 Subjects
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms, D2[N=126,125,82,79]
|
6 Subjects
|
7 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal, D2 [N=126,125,82,79]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal, D2 [N=126,125,82,79]
|
6 Subjects
|
7 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, D2 [N=126,125,82,79]
|
40 Subjects
|
37 Subjects
|
8 Subjects
|
12 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, D2 [N=126,125,82,79]
|
4 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, D2 [N=126,125,82,79]
|
39 Subjects
|
37 Subjects
|
8 Subjects
|
12 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, D2 [N=126,125,82,79]
|
13 Subjects
|
20 Subjects
|
7 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, D2 [N=126,125,82,79]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, D2 [N=126,125,82,79]
|
13 Subjects
|
19 Subjects
|
7 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature (Axillary), D2 [N=126,125,82,79]
|
11 Subjects
|
17 Subjects
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature(Axillary),D2 [N=126,125,82,79]
|
2 Subjects
|
5 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature(Axillary),D2 [N=126,125,82,79]
|
10 Subjects
|
15 Subjects
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Arthralgia, D3 [N=126,124,0,0]
|
19 Subjects
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Arthralgia, D3 [N=126,124,0,0]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Arthralgia, D3 [N=126,124,0,0]
|
19 Subjects
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, D3 [N=126,124,0,0]
|
15 Subjects
|
8 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, D3 [N=126,124,0,0]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, D3 [N=126,124,0,0]
|
15 Subjects
|
8 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal, D3 [N=126,124,0,0]
|
4 Subjects
|
6 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal, D3 [N=126,124,0,0]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal, D3 [N=126,124,0,0]
|
4 Subjects
|
6 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, D3 [N=126,124,0,0]
|
39 Subjects
|
17 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, D3 [N=126,124,0,0]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache Headache, D3 [N=126,124,0,0]
|
39 Subjects
|
17 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, D3 [N=126,124,0,0]
|
15 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, D3 [N=126,124,0,0]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, D3 [N=126,124,0,0]
|
15 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature (Axillary), D3 [N=126,124,0,0]
|
7 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature (Axillary), D3 [N=126,124,0,0]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature (Axillary), D3 [N=126,124,0,0]
|
7 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Arthralgia, Across [N=126,125,82,80]
|
33 Subjects
|
31 Subjects
|
11 Subjects
|
11 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Arthralgia, Across [N=126,125,82,80]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Arthralgia, Across [N=126,125,82,80]
|
32 Subjects
|
30 Subjects
|
11 Subjects
|
10 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, Across [N=126,125,82,80]
|
28 Subjects
|
22 Subjects
|
10 Subjects
|
10 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, Across [N=126,125,82,80]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, Across [N=126,125,82,80]
|
28 Subjects
|
22 Subjects
|
10 Subjects
|
9 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal, Across [N=126,125,82,80]
|
16 Subjects
|
12 Subjects
|
8 Subjects
|
7 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal, Across [N=126,125,82,80]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal, Across [N=126,125,82,80]
|
15 Subjects
|
12 Subjects
|
8 Subjects
|
6 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, Across [N=126,125,82,80]
|
63 Subjects
|
52 Subjects
|
20 Subjects
|
24 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, Across [N=126,125,82,80]
|
5 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, Across [N=126,125,82,80]
|
62 Subjects
|
51 Subjects
|
18 Subjects
|
22 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, Across [N=126,125,82,80]
|
29 Subjects
|
33 Subjects
|
13 Subjects
|
13 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, Across [N=126,125,82,80]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, Across [N=126,125,82,80]
|
29 Subjects
|
31 Subjects
|
13 Subjects
|
12 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature/(Axillary),Across[N=126,125,82,80]
|
23 Subjects
|
19 Subjects
|
10 Subjects
|
7 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature, Across [N=126,125,82,80]
|
3 Subjects
|
6 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature, Across [N=126,125,82,80]
|
20 Subjects
|
16 Subjects
|
7 Subjects
|
5 Subjects
|
SECONDARY outcome
Timeframe: During a 21-day (Days 0 - 20) follow-up period after vaccinationPopulation: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Any AEs
|
60 Subjects
|
82 Subjects
|
35 Subjects
|
20 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Grade 3 AEs
|
1 Subjects
|
1 Subjects
|
NA Subjects
Grade 3 AEs were not reported in this group.
|
NA Subjects
Grade 3 AEs were not reported in this group.
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Related AEs
|
12 Subjects
|
7 Subjects
|
7 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: During Day 0 to Telephone Contact (TC) Day 84 overall.Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Any AEs
|
75 Subjects
|
92 Subjects
|
59 Subjects
|
50 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Grade 3 AEs
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Related AEs
|
7 Subjects
|
6 Subjects
|
3 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to 364)Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to 364)Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=156 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=104 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
4 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 0, 42, 182, 192 and 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182, 192 and 364.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=155 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=152 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=103 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=101 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10
A/INDO, Day 0 [N=155,152,103,101]
|
22 Subjects
|
15 Subjects
|
8 Subjects
|
14 Subjects
|
|
Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10
A/INDO, Day 42 [N=155,152,103,101]
|
155 Subjects
|
151 Subjects
|
9 Subjects
|
19 Subjects
|
|
Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10
A/INDO, Day 182 [N=155,152,103,101]
|
154 Subjects
|
152 Subjects
|
2 Subjects
|
12 Subjects
|
|
Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10
A/INDO, Day 192 [N=127,0,84,0]
|
127 Subjects
|
0 Subjects
|
37 Subjects
|
0 Subjects
|
|
Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10
A/INDO, Day 364 [N=151,147,100,0]
|
151 Subjects
|
147 Subjects
|
57 Subjects
|
0 Subjects
|
|
Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10
A/TURK, Day 182 [N=127,152,84,101]
|
126 Subjects
|
152 Subjects
|
17 Subjects
|
26 Subjects
|
|
Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10
A/TURK, Day 364 [N=151,147,100,0]
|
151 Subjects
|
147 Subjects
|
95 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 42, 182, 192 and 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
A seroconverted subject was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Seroconversion rates against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=155 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=152 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=103 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=101 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease
A/INDO, Day 42 [N=155,152,103,101]
|
154 Subjects
|
151 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease
A/INDO, Day 182 [N=155,152,103,101]
|
122 Subjects
|
121 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease
A/INDO, Day 192 [N=127,0,84,0]
|
127 Subjects
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease
A/INDO, Day 364 [N=151,147,100,0]
|
151 Subjects
|
100 Subjects
|
1 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 0,42, 182, 192 and 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Seroprotection rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 -Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seroprotection rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182 and 192.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=155 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=152 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=103 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=101 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
A/INDO, Day 0 [N=155,152,103,101]
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
A/INDO, Day 42 [N=155,152,103,101]
|
154 Subjects
|
151 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
A/INDO, Day 182 [N=155,152,103,101]
|
125 Subjects
|
122 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
A/INDO, Day 192 [N=127,0,84,0]
|
127 Subjects
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
A/INDO, Day 364 [N=151,147,100,0]
|
151 Subjects
|
102 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
A/TURK, Day 182 [N=127,0,84,0]
|
73 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
A/TURK, Day 192 [N=127,0,84,0]
|
127 Subjects
|
0 Subjects
|
28 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 42, 182, 192 and 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. MGI against the A/turkey/Turkey/01/2005 (H5N1 virus) strain were tabulated on Days 42, 182 and 364.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=155 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=152 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=103 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=101 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Mean Geometric Increase for Anti-H5N1 Antibody Titers
A/INDO, Day 42 [N=155,152,103,101]
|
96.9 Titer
Interval 84.9 to 110.4
|
108.4 Titer
Interval 94.2 to 124.7
|
1 Titer
Interval 1.0 to 1.1
|
1.1 Titer
Interval 0.9 to 1.2
|
|
Mean Geometric Increase for Anti-H5N1 Antibody Titers
A/INDO, Day 182 [N=155,152,103,101]
|
9.1 Titer
Interval 8.3 to 10.1
|
9.8 Titer
Interval 9.0 to 10.8
|
0.9 Titer
Interval 0.9 to 1.0
|
1 Titer
Interval 0.9 to 1.1
|
|
Mean Geometric Increase for Anti-H5N1 Antibody Titers
A/INDO, Day 192 [N=127,0,84,0]
|
117.7 Titer
Interval 103.0 to 134.5
|
NA Titer
MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Day 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group only.
|
1.4 Titer
Interval 1.2 to 1.6
|
NA Titer
MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Day 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group only.
|
|
Mean Geometric Increase for Anti-H5N1 Antibody Titers
A/INDO, Day 364 [N=151,147,100,0]
|
36.2 Titer
Interval 32.0 to 40.9
|
7.4 Titer
Interval 6.7 to 8.2
|
1.6 Titer
Interval 1.4 to 1.7
|
NA Titer
MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Day 364 for GSK1562902A Formulation 1 and 2-Havrix/Havrix Jr Group, GSK1562902A Formulation 1-Havrix/Havrix Jr Group and GSK1562902A Formulation 2-Havrix/Havrix Jr Group only.
|
|
Mean Geometric Increase for Anti-H5N1 Antibody Titers
A/TURK, Day 42 [N=155,152,103,101]
|
27.7 Titer
Interval 24.0 to 31.9
|
33.1 Titer
Interval 28.6 to 38.3
|
1.1 Titer
Interval 1.0 to 1.3
|
1.2 Titer
Interval 1.1 to 1.3
|
|
Mean Geometric Increase for Anti-H5N1 Antibody Titers
A/TURK, Day 182 [N=155,152,103,101]
|
5.6 Titer
Interval 5.0 to 6.3
|
6.6 Titer
Interval 6.0 to 7.4
|
1 Titer
Interval 0.9 to 1.1
|
1 Titer
Interval 0.9 to 1.1
|
|
Mean Geometric Increase for Anti-H5N1 Antibody Titers
A/TURK, Day 364 [N=151,147,100,0]
|
31.4 Titer
Interval 26.9 to 36.7
|
5.6 Titer
Interval 5.0 to 6.3
|
3 Titer
Interval 2.6 to 3.4
|
NA Titer
MGI against the A/turkey/Turkey/01/2005 (H5N1) strain were tabulated on Day 364 for GSK1562902A Formulation 1 and 2-Havrix/Havrix Jr Group, GSK1562902A Formulation 1-Havrix/Havrix Jr Group and GSK1562902A Formulation 2-Havrix/Havrix Jr Group only
|
SECONDARY outcome
Timeframe: At Days 192 and 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
Booster seroconversion rates against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated on Days 192 and 364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=151 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=100 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
A/TURK, Day 192 [N=127,84]
|
127 Subjects
|
27 Subjects
|
—
|
—
|
|
Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
A/TURK, Day 364 [N=151,100]
|
105 Subjects
|
18 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 192 and 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
Boooster factor against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated 95% CI on Days 192,364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=151 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=100 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease
A/TURK, Day 192 [N=127,84]
|
18.6 Titer
Interval 16.3 to 21.3
|
4.1 Titer
Interval 3.3 to 5.2
|
—
|
—
|
|
Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease
A/TURK, Day 364 [N=151,100]
|
5.6 Titer
Interval 5.0 to 6.3
|
3 Titer
Interval 2.7 to 3.4
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 42, 182 192 and 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 0, 42,182, 192 and 364.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=151 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=147 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=100 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=102 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/INDO, Day 0 [N=149,145,98,99]
|
22 Subjects
|
17 Subjects
|
8 Subjects
|
14 Subjects
|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/INDO,Day 42 [N=150,146,99,100]
|
150 Subjects
|
146 Subjects
|
9 Subjects
|
15 Subjects
|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/INDO, Day 182 [N=151,147,100,102]
|
150 Subjects
|
147 Subjects
|
7 Subjects
|
4 Subjects
|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/INDO, Day 192 [N=149,0,99,0]
|
149 Subjects
|
0 Subjects
|
75 Subjects
|
0 Subjects
|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/INDO, Day 364 [N=149,147,100,0]
|
149 Subjects
|
147 Subjects
|
73 Subjects
|
0 Subjects
|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/TURK, Day 0, [N=149,145,98,100]
|
21 Subjects
|
18 Subjects
|
8 Subjects
|
19 Subjects
|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/TURK, Day 42, [N=150,146,98,100]
|
150 Subjects
|
145 Subjects
|
10 Subjects
|
20 Subjects
|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/TURK, Day 182, [N=151,147,100,101]
|
150 Subjects
|
145 Subjects
|
11 Subjects
|
10 Subjects
|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/TURK, Day 192, [N=150,0,100,0]
|
150 Subjects
|
0 Subjects
|
90 Subjects
|
0 Subjects
|
|
Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
A/TURK, Day 364, [N=149,145,98,0]
|
149 Subjects
|
145 Subjects
|
95 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 42, 182 192 and 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=149 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=145 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=98 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=98 Participants
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies
A/INDO,Day 42 [N=149,144,98,98]
|
147 Subjects
|
142 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies
A/INDO, Day 182 [N=149,145,98,98]
|
127 Subjects
|
115 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies
A/INDO, Day 192 [N=147,0,97,0]
|
147 Subjects
|
0 Subjects
|
5 Subjects
|
0 Subjects
|
|
Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies
A/INDO, Day 364 [N=148,145,98,0]
|
144 Subjects
|
126 Subjects
|
8 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 192 and 364Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.
This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
Outcome measures
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=150 Participants
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=100 Participants
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies
A/TURK, Day 192, [N=150,100]
|
141 Subjects
|
38 Subjects
|
—
|
—
|
|
Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies
A/TURK, Day 364, [N=149,98]
|
86 Subjects
|
36 Subjects
|
—
|
—
|
Adverse Events
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
Serious events: 4 serious events
Other events: 138 other events
Deaths: 0 deaths
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
Serious events: 1 serious events
Other events: 145 other events
Deaths: 0 deaths
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Havrix / Havrix Jr Group
Serious events: 0 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=156 participants at risk
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
n=156 participants at risk
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=104 participants at risk
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=104 participants at risk
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.64%
1/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Infections and infestations
Bronchitis
|
0.64%
1/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Infections and infestations
Gastroenteritis
|
0.64%
1/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.64%
1/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Infections and infestations
Periorbital cellulitis
|
0.64%
1/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Infections and infestations
Typhoid fever
|
0.64%
1/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Infections and infestations
Urinary tract infection
|
0.64%
1/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
Other adverse events
| Measure |
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
n=156 participants at risk
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
n=156 participants at risk
Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
n=104 participants at risk
Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
Havrix / Havrix Jr Group
n=104 participants at risk
Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
|
|---|---|---|---|---|
|
General disorders
Pain
|
81.4%
127/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
82.7%
129/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
70.2%
73/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
51.0%
53/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Swelling
|
9.6%
15/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
8.3%
13/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
1.9%
2/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.96%
1/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Diarrhoea/vomiting
|
6.7%
2/30 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
9.7%
3/31 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
9.1%
2/22 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
0.00%
0/24 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Drowsiness
|
16.7%
5/30 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
25.8%
8/31 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
13.6%
3/22 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
8.3%
2/24 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Irritability / fussiness
|
26.7%
8/30 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
32.3%
10/31 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
13.6%
3/22 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
4.2%
1/24 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Loss of appetite
|
26.7%
8/30 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
29.0%
9/31 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
13.6%
3/22 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
4.2%
1/24 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Temperature
|
18.3%
23/126 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
15.2%
19/125 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
12.2%
10/82 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
8.8%
7/80 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Arthralgia
|
26.2%
33/126 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
24.8%
31/125 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
13.4%
11/82 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
13.8%
11/80 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Fatigue
|
22.2%
28/126 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
17.6%
22/125 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
12.2%
10/82 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
12.5%
10/80 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Gastrointestinal symptoms
|
12.7%
16/126 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
9.6%
12/125 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
9.8%
8/82 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
8.8%
7/80 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Headache
|
50.0%
63/126 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
41.6%
52/125 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
24.4%
20/82 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
30.0%
24/80 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
General disorders
Myalgia
|
23.0%
29/126 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
26.4%
33/125 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
15.9%
13/82 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
16.2%
13/80 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.8%
45/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
40.4%
63/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
29.8%
31/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
26.0%
27/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Infections and infestations
Viral infection
|
6.4%
10/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
12.8%
20/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
17.3%
18/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
9.6%
10/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Infections and infestations
Rhinitis
|
3.2%
5/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
3.2%
5/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
5.8%
6/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
1.9%
2/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
3/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
5.1%
8/156 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
2.9%
3/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
5.8%
6/104 • Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
|
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