Trial Outcomes & Findings for Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over (NCT NCT00532298)
NCT ID: NCT00532298
Last Updated: 2018-06-08
Results Overview
Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1596 participants
Primary outcome timeframe
At Days 0 and 21
Results posted on
2018-06-08
Participant Flow
Two subjects enrolled in this study were not vaccinated and as such not accounted for under Started.
Participant milestones
| Measure |
GSK576389A - 2007/2008 Season - 1 Container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
GSK576389A- 2006/2007 Season - 1 Container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
264
|
268
|
263
|
269
|
266
|
264
|
|
Overall Study
COMPLETED
|
264
|
267
|
261
|
267
|
265
|
263
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
GSK576389A - 2007/2008 Season - 1 Container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
GSK576389A- 2006/2007 Season - 1 Container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
1
|
1
|
Baseline Characteristics
Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
Baseline characteristics by cohort
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=269 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=266 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=264 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=264 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=268 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=263 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
Total
n=1594 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.2 Years
STANDARD_DEVIATION 5.56 • n=5 Participants
|
73.0 Years
STANDARD_DEVIATION 5.16 • n=7 Participants
|
72.8 Years
STANDARD_DEVIATION 5.06 • n=5 Participants
|
73.3 Years
STANDARD_DEVIATION 5.86 • n=4 Participants
|
73.2 Years
STANDARD_DEVIATION 5.72 • n=21 Participants
|
73.0 Years
STANDARD_DEVIATION 5.20 • n=8 Participants
|
73.08 Years
STANDARD_DEVIATION 5.43 • n=8 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
152 Participants
n=21 Participants
|
153 Participants
n=8 Participants
|
900 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
110 Participants
n=8 Participants
|
694 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available. This primary outcome was assessed only on those groups receiving any of the GSK Bio's influenza vaccine GSK576389A formulations.
Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=258 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=263 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
A/New Caledonia at Day 0 (N=259;259;0;0;0;0)
|
37.9 titer
Interval 33.1 to 43.3
|
40.1 titer
Interval 34.7 to 46.4
|
—
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
—
|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
A/New Caledonia at Day 21 (N=259;259;0;0;0;0)
|
130.8 titer
Interval 117.0 to 146.3
|
138.5 titer
Interval 123.2 to 155.8
|
—
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
—
|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
A/Solomon Islands at Day 0 (N=0;0;0;258;263;0)
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
—
|
9.4 titer
Interval 8.4 to 10.5
|
9.0 titer
Interval 8.1 to 9.9
|
—
|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
A/Solomon Islands at Day 21 (N=0;0;0;258;263;0)
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
—
|
82.0 titer
Interval 70.9 to 94.8
|
88.6 titer
Interval 76.4 to 102.7
|
—
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.
Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=255 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=258 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=263 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=257 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
A/New Caledonia at Day 0 (N=259;259;255;0;0;0)
|
37.9 titer
Interval 33.1 to 43.3
|
40.1 titer
Interval 34.7 to 46.4
|
35.3 titer
Interval 30.6 to 40.7
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
|
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
A/New Caledonia at Day 21 (N=259;259;255;0;0;0)
|
130.8 titer
Interval 117.0 to 146.3
|
138.5 titer
Interval 123.2 to 155.8
|
114.7 titer
Interval 102.0 to 129.0
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
|
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Solomon Islands at Day 0 (N=0;0;0;258;263;257)
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
9.4 titer
Interval 8.4 to 10.5
|
9.0 titer
Interval 8.1 to 9.9
|
8.5 titer
Interval 7.7 to 9.4
|
|
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Solomon Islands at Day 21 (N=0;0;0;258;263;257)
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA titer
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
82.0 titer
Interval 70.9 to 94.8
|
88.6 titer
Interval 76.4 to 102.7
|
61.0 titer
Interval 52.1 to 71.6
|
|
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Wisconsin at Day 0 (N=259;259;255;258;263;257)
|
47.7 titer
Interval 39.9 to 57.0
|
52.8 titer
Interval 44.1 to 63.2
|
53.3 titer
Interval 44.2 to 64.2
|
56.7 titer
Interval 47.7 to 67.5
|
52.8 titer
Interval 44.3 to 62.9
|
42.8 titer
Interval 35.8 to 51.2
|
|
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Wisconsin at Day 21 (N=259;259;255;258;263;257)
|
379.7 titer
Interval 328.5 to 439.0
|
409.9 titer
Interval 360.3 to 466.2
|
275.5 titer
Interval 241.6 to 314.3
|
399.9 titer
Interval 351.4 to 455.1
|
367.4 titer
Interval 322.9 to 418.2
|
178.9 titer
Interval 153.8 to 208.0
|
|
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
B/Malaysia at Day 0 (N=259;259;255;258;263;257)
|
57.9 titer
Interval 50.4 to 66.6
|
59.5 titer
Interval 51.2 to 69.2
|
59.6 titer
Interval 50.9 to 69.7
|
68.0 titer
Interval 59.2 to 78.2
|
51.6 titer
Interval 44.8 to 59.6
|
54.3 titer
Interval 46.5 to 63.5
|
|
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
B/Malaysia at Day 21 (N=259;259;255;258;263;257)
|
236.4 titer
Interval 212.6 to 262.9
|
213.8 titer
Interval 189.7 to 241.0
|
193.2 titer
Interval 170.0 to 219.5
|
253.6 titer
Interval 227.8 to 282.2
|
201.9 titer
Interval 180.0 to 226.6
|
180.5 titer
Interval 158.5 to 205.7
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=255 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=258 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=263 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=257 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A/New Caledonia strain (N=259;259;255;0;0;0)
|
104 Subjects
|
95 Subjects
|
78 Subjects
|
NA Subjects
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
|
The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Solomon Islands strain (N=0;0;0;258;263;257)
|
NA Subjects
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
177 Subjects
|
192 Subjects
|
161 Subjects
|
|
The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Wisconsin strain (N=259;259;255;258;263;257)
|
177 Subjects
|
188 Subjects
|
128 Subjects
|
171 Subjects
|
173 Subjects
|
109 Subjects
|
|
The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
B/Malaysia strain (N=259;259;255;258;263;257)
|
110 Subjects
|
100 Subjects
|
85 Subjects
|
108 Subjects
|
111 Subjects
|
88 Subjects
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=255 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=258 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=263 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=257 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
HI Antibody Seroconversion Factors
A/New Caledonia strain (N=259;259;255;0;0;0)
|
3.5 fold increase
Interval 3.0 to 4.0
|
3.5 fold increase
Interval 3.0 to 4.0
|
3.3 fold increase
Interval 2.8 to 3.8
|
NA fold increase
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA fold increase
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA fold increase
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
|
HI Antibody Seroconversion Factors
A/Wisconsin strain (N=259;259;255;258;263;257)
|
8.0 fold increase
Interval 6.7 to 9.4
|
7.8 fold increase
Interval 6.6 to 9.2
|
5.2 fold increase
Interval 4.3 to 6.3
|
7.0 fold increase
Interval 6.0 to 8.3
|
7.0 fold increase
Interval 5.9 to 8.3
|
4.2 fold increase
Interval 3.5 to 5.0
|
|
HI Antibody Seroconversion Factors
A/Solomon Islands strain (N=0;0;0;258;263;257)
|
NA fold increase
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA fold increase
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA fold increase
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
8.7 fold increase
Interval 7.5 to 10.2
|
9.9 fold increase
Interval 8.5 to 11.5
|
7.2 fold increase
Interval 6.1 to 8.4
|
|
HI Antibody Seroconversion Factors
B/Malaysia strain (N=259;259;255;258;263;257)
|
4.1 fold increase
Interval 3.5 to 4.7
|
3.6 fold increase
Interval 3.1 to 4.2
|
3.2 fold increase
Interval 2.8 to 3.8
|
3.7 fold increase
Interval 3.2 to 4.3
|
3.9 fold increase
Interval 3.4 to 4.5
|
3.3 fold increase
Interval 2.8 to 3.9
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.
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. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=259 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=255 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=258 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=263 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=257 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A/New Caledonia at Day 0 (N=259;259;255;0;0;0)
|
160 Subjects
|
163 Subjects
|
156 Subjects
|
NA Subjects
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
|
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A/New Caledonia at Day 21 (N=259;259;255;0;0;0)
|
252 Subjects
|
246 Subjects
|
239 Subjects
|
NA Subjects
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/New Caledonia vaccine strain as per protocol.
|
|
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Solomon Islands at Day 0 (N=0;0;0;258;263;257)
|
NA Subjects
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
30 Subjects
|
26 Subjects
|
26 Subjects
|
|
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Solomon Islands at Day 21 (N=0;0;0;258;263;257)
|
NA Subjects
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
NA Subjects
Subjects in this group were not analysed for A/Solomon Islands vaccine strain as per protocol.
|
202 Subjects
|
215 Subjects
|
187 Subjects
|
|
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Wisconsin at Day 0 (N=259;259;255;258;263;257)
|
169 Subjects
|
174 Subjects
|
172 Subjects
|
180 Subjects
|
171 Subjects
|
158 Subjects
|
|
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A/Wisconsin at Day 21 (N=259;259;255;258;263;257)
|
252 Subjects
|
257 Subjects
|
249 Subjects
|
255 Subjects
|
259 Subjects
|
239 Subjects
|
|
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
B/Malaysia at Day 0 (N=259;259;255;258;263;257)
|
194 Subjects
|
188 Subjects
|
185 Subjects
|
200 Subjects
|
184 Subjects
|
182 Subjects
|
|
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
B/Malaysia at Day 21 (N=259;259;255;258;263;257)
|
255 Subjects
|
253 Subjects
|
249 Subjects
|
257 Subjects
|
260 Subjects
|
246 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccinationPopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. \>100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was \>20mm.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=268 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=265 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=263 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=263 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=268 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=261 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any ecchymosis
|
4 Subjects
|
4 Subjects
|
6 Subjects
|
7 Subjects
|
7 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any pain
|
165 Subjects
|
146 Subjects
|
47 Subjects
|
148 Subjects
|
144 Subjects
|
37 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 pain
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any redness
|
113 Subjects
|
131 Subjects
|
59 Subjects
|
108 Subjects
|
120 Subjects
|
51 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 redness
|
19 Subjects
|
27 Subjects
|
4 Subjects
|
19 Subjects
|
24 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any swelling
|
52 Subjects
|
53 Subjects
|
13 Subjects
|
53 Subjects
|
49 Subjects
|
18 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 swelling
|
4 Subjects
|
6 Subjects
|
0 Subjects
|
0 Subjects
|
5 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccinationPopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
Duration was defined as number of days with any grade of local symptoms.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=165 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=146 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=58 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=148 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=144 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=50 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
Duration of Solicited Local AEs
Redness (N=113;131;58;108;120;50)
|
3.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
4.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local AEs
Ecchymosis (N=4;4;5;7;7;10)
|
3.0 Days
Interval 1.0 to 7.0
|
4.0 Days
Interval 3.0 to 5.0
|
6.0 Days
Interval 1.0 to 7.0
|
6.0 Days
Interval 3.0 to 7.0
|
3.0 Days
Interval 1.0 to 5.0
|
6.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local AEs
Pain (N=165;146;47;148;144;37)
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
3.0 Days
Interval 1.0 to 6.0
|
3.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local AEs
Swelling (N=52;53;12;53;49;18)
|
3.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
2.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccinationPopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=268 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=265 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=263 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=264 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=267 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=261 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any arthralgia
|
58 Subjects
|
36 Subjects
|
19 Subjects
|
39 Subjects
|
30 Subjects
|
20 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 arthralgia
|
3 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related arthralgia
|
57 Subjects
|
36 Subjects
|
16 Subjects
|
39 Subjects
|
30 Subjects
|
19 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any fatigue
|
89 Subjects
|
90 Subjects
|
39 Subjects
|
83 Subjects
|
82 Subjects
|
33 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 fatigue
|
4 Subjects
|
3 Subjects
|
0 Subjects
|
4 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related fatigue
|
89 Subjects
|
89 Subjects
|
34 Subjects
|
81 Subjects
|
81 Subjects
|
32 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any headache
|
76 Subjects
|
67 Subjects
|
26 Subjects
|
62 Subjects
|
58 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 headache
|
6 Subjects
|
3 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related headache
|
73 Subjects
|
64 Subjects
|
23 Subjects
|
62 Subjects
|
58 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any myalgia
|
85 Subjects
|
63 Subjects
|
25 Subjects
|
75 Subjects
|
77 Subjects
|
29 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 myalgia
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related myalgia
|
83 Subjects
|
63 Subjects
|
22 Subjects
|
75 Subjects
|
77 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any nausea
|
22 Subjects
|
25 Subjects
|
14 Subjects
|
26 Subjects
|
18 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 nausea
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related nausea
|
20 Subjects
|
25 Subjects
|
11 Subjects
|
24 Subjects
|
18 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any shivering
|
46 Subjects
|
25 Subjects
|
6 Subjects
|
45 Subjects
|
25 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 shivering
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related shivering
|
45 Subjects
|
25 Subjects
|
3 Subjects
|
44 Subjects
|
25 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any temperature
|
8 Subjects
|
6 Subjects
|
2 Subjects
|
12 Subjects
|
13 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 temperature
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related temperature
|
8 Subjects
|
6 Subjects
|
1 Subjects
|
12 Subjects
|
13 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccinationPopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
Duration was defined as number of days with any grade of general symptoms.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=89 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=90 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=39 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=83 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=82 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=33 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
Duration of Solicited General AEs
Temperature (N=4;4;1;7;9;0)
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
3.0 Days
Interval 3.0 to 3.0
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 4.0
|
NA Days
Information on duration of fever was missing from these subject's symptom sheets
|
|
Duration of Solicited General AEs
Arthralgia (N=58;36;19;39;30;20)
|
2.0 Days
Interval 1.0 to 7.0
|
1.5 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
3.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General AEs
Fatigue (N=89;90;39;83;82;33)
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General AEs
Headache (N=76;67;26;62;58;27)
|
1.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
1.5 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 6.0
|
1.0 Days
Interval 1.0 to 6.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General AEs
Myalgia (N=85;63;25;75;77;29)
|
2.0 Days
Interval 1.0 to 6.0
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General AEs
Nausea (N=22;25;14;26;18;10)
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 6.0
|
1.0 Days
Interval 1.0 to 3.0
|
1.5 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited General AEs
Shivering (N=46;25;6;45;25;6)
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 3.0
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: During a 21-day follow-up period (Day 0-20) after vaccinationPopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=269 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=266 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=264 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=264 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=268 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=263 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Any AE(s)
|
43 Subjects
|
39 Subjects
|
36 Subjects
|
45 Subjects
|
53 Subjects
|
29 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Grade 3 AE(s)
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Related AE(s)
|
22 Subjects
|
21 Subjects
|
11 Subjects
|
28 Subjects
|
30 Subjects
|
12 Subjects
|
SECONDARY outcome
Timeframe: During a 21-day follow-up period (Day 0-20) after vaccinationPopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=269 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=266 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=264 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=264 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=268 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=263 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Any MSC(s)
|
7 Subjects
|
4 Subjects
|
11 Subjects
|
5 Subjects
|
11 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Grade 3 MSC(s)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Related MSC(s)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
4 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: During a 21-day follow-up period (Day 0-20) after vaccinationPopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=269 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=266 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=264 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=264 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=268 Participants
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=263 Participants
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAE(S)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
Adverse Events
GSK576389A- 2006/2007 Season - 1 Container Group
Serious events: 2 serious events
Other events: 233 other events
Deaths: 0 deaths
GSK576389A - 2006/2007 Season - 2 Containers Group
Serious events: 0 serious events
Other events: 224 other events
Deaths: 0 deaths
Fluarix 2006/2007 Season Group
Serious events: 0 serious events
Other events: 145 other events
Deaths: 0 deaths
GSK576389A - 2007/2008 Season - 1 Container Group
Serious events: 2 serious events
Other events: 224 other events
Deaths: 0 deaths
GSK576389A - 2007/2008 Season - 2 Containers Group
Serious events: 0 serious events
Other events: 219 other events
Deaths: 0 deaths
Fluarix 2007/2008 Season Group
Serious events: 1 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=269 participants at risk
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=266 participants at risk
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=264 participants at risk
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=264 participants at risk
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=268 participants at risk
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=263 participants at risk
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/269 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/266 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.38%
1/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/269 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/266 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.38%
1/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Fatigue
|
0.00%
0/269 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/266 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.38%
1/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.37%
1/269 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/266 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.37%
1/269 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/266 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
Other adverse events
| Measure |
GSK576389A- 2006/2007 Season - 1 Container Group
n=269 participants at risk
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
|
GSK576389A - 2006/2007 Season - 2 Containers Group
n=266 participants at risk
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
|
Fluarix 2006/2007 Season Group
n=264 participants at risk
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
|
GSK576389A - 2007/2008 Season - 1 Container Group
n=264 participants at risk
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
|
GSK576389A - 2007/2008 Season - 2 Containers Group
n=268 participants at risk
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
|
Fluarix 2007/2008 Season Group
n=263 participants at risk
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
|
|---|---|---|---|---|---|---|
|
General disorders
Pain
|
61.6%
165/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
55.1%
146/265 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
17.9%
47/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
56.3%
148/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
53.7%
144/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
14.2%
37/261 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Redness
|
42.2%
113/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
49.4%
131/265 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
22.4%
59/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
41.1%
108/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
44.8%
120/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
19.5%
51/261 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Swelling
|
19.4%
52/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
20.0%
53/265 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
4.9%
13/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
20.2%
53/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
18.3%
49/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
6.9%
18/261 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Arthralgia
|
21.6%
58/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
13.6%
36/265 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
7.2%
19/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
14.8%
39/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
11.2%
30/267 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
7.7%
20/261 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Fatigue
|
33.2%
89/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
34.0%
90/265 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
14.8%
39/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
31.4%
83/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
30.7%
82/267 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
12.6%
33/261 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Headache
|
28.4%
76/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
25.3%
67/265 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
9.9%
26/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
23.5%
62/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
21.7%
58/267 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
10.3%
27/261 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Myalgia
|
31.7%
85/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
23.8%
63/265 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
9.5%
25/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
28.4%
75/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
28.8%
77/267 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
11.1%
29/261 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Nausea
|
8.2%
22/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
9.4%
25/265 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
5.3%
14/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
9.8%
26/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
6.7%
18/267 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
3.8%
10/261 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Shivering
|
17.2%
46/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
9.4%
25/265 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
2.3%
6/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
17.0%
45/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
9.4%
25/267 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
2.3%
6/261 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Injection site pruritus
|
4.5%
12/269 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
5.3%
14/266 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
2.7%
7/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
4.9%
13/264 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
5.6%
15/268 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
1.9%
5/263 • Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
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