Trial Outcomes & Findings for Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) (NCT NCT00971425)
NCT ID: NCT00971425
Last Updated: 2018-08-17
Results Overview
Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
145 participants
Primary outcome timeframe
At Day 42
Results posted on
2018-08-17
Participant Flow
Participant milestones
| Measure |
Placebo-Pandemrix-Fluarix Group
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
73
|
|
Overall Study
COMPLETED
|
71
|
71
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo-Pandemrix-Fluarix Group
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
Baseline characteristics by cohort
| Measure |
Placebo-Pandemrix-Fluarix Group
n=72 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=73 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.1 Years
STANDARD_DEVIATION 5.16 • n=5 Participants
|
69.7 Years
STANDARD_DEVIATION 5.59 • n=7 Participants
|
69.4 Years
STANDARD_DEVIATION 5.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain
|
309.8 titer
Interval 246.4 to 389.6
|
227.5 titer
Interval 181.5 to 285.3
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain
|
64 subjects
|
67 subjects
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain
|
61 subjects
|
59 subjects
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain
|
33.6 fold increase
Interval 25.5 to 44.3
|
16.5 fold increase
Interval 12.4 to 21.9
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain
|
64 subjects
|
67 subjects
|
SECONDARY outcome
Timeframe: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 A/Cal/7/09 (N=64;67)
|
8.7 titer
Interval 6.9 to 11.1
|
7.4 titer
Interval 6.3 to 8.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 A/Cal/7/09 (N=64;67)
|
9.2 titer
Interval 7.3 to 11.7
|
13.8 titer
Interval 11.3 to 16.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 21 A/Cal/7/09 (N=64;67)
|
147.5 titer
Interval 111.9 to 194.4
|
109.6 titer
Interval 82.4 to 145.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 A/Cal/7/09 (N=63;66)
|
223.8 titer
Interval 181.2 to 276.5
|
174.0 titer
Interval 138.7 to 218.4
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 6 A/Cal/7/09 (N=60;63)
|
102.0 titer
Interval 78.6 to 132.3
|
74.1 titer
Interval 59.0 to 92.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 12 A/Cal/7/09 (N=60;64)
|
35.6 titer
Interval 27.0 to 47.0
|
25.7 titer
Interval 20.8 to 31.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 A/Bri/59/07 (N=64;67)
|
23.1 titer
Interval 18.9 to 28.4
|
20.8 titer
Interval 16.7 to 25.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 A/Bri/59/07 (N=64;67)
|
22.4 titer
Interval 18.2 to 27.5
|
64.0 titer
Interval 50.8 to 80.5
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 42 A/Bri/59/07 (N=64;67)
|
32.3 titer
Interval 26.4 to 39.7
|
56.5 titer
Interval 45.3 to 70.5
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 A/Bri/59/07 (N=63;66)
|
55.7 titer
Interval 45.1 to 68.7
|
49.8 titer
Interval 40.1 to 61.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 B/Bri/60/08 (N=64;67)
|
120.7 titer
Interval 98.7 to 147.7
|
135.6 titer
Interval 107.2 to 171.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 B/Bri/60/08 (N=64;67)
|
118.8 titer
Interval 97.7 to 144.5
|
351.2 titer
Interval 285.6 to 431.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 42 B/Bri/60/08 (N=64;67)
|
182.2 titer
Interval 154.7 to 214.6
|
291.5 titer
Interval 238.8 to 355.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 B/Bri/60/08 (N=63;66)
|
291.3 titer
Interval 246.2 to 344.7
|
273.3 titer
Interval 225.3 to 331.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 A/Uru/716/07 (N=64;67)
|
26.2 titer
Interval 19.2 to 35.7
|
22.5 titer
Interval 16.2 to 31.2
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 A/Uru/716/07 (N=64;67)
|
25.5 titer
Interval 18.8 to 34.6
|
100.9 titer
Interval 75.9 to 134.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 42 A/Uru/716/07 (N=64;67)
|
27.1 titer
Interval 20.7 to 35.4
|
69.2 titer
Interval 51.0 to 93.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 A/Uru/716/07 (N=63;66)
|
85.9 titer
Interval 65.2 to 113.2
|
62.4 titer
Interval 46.9 to 83.2
|
SECONDARY outcome
Timeframe: At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
The cut-off was a titer of 1:10 and this titer was considered as seropositivity. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 A/Uru/716/07 (N=63;66)
|
63 subjects
|
65 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 A/Cal/7/09 (N=64;67)
|
22 subjects
|
21 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 A/Cal/7/09 (N=64;67)
|
26 subjects
|
50 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 21 A/Cal/7/09 (N=64;67)
|
64 subjects
|
67 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 A/Cal/7/09 (N=63;66)
|
63 subjects
|
66 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 6 A/Cal/7/09 (N=60;63)
|
60 subjects
|
63 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 12 A/Cal/7/09 (N=60;64)
|
57 subjects
|
60 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 A/Bri/59/07 (N=64;67)
|
57 subjects
|
58 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 A/Bri/59/07 (N=64;67)
|
56 subjects
|
67 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 42 A/Bri/59/07 (N=64;67)
|
62 subjects
|
67 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 A/Bri/59/07 (N=63;66)
|
62 subjects
|
66 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 B/Bri/60/08 (N=64;67)
|
64 subjects
|
67 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 B/Bri/60/08 (N=64;67)
|
64 subjects
|
67 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 42 B/Bri/60/08 (N=64;67)
|
64 subjects
|
67 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 B/Bri/60/08 (N=63;66)
|
63 subjects
|
66 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 A/Uru/716/07 (N=64;67)
|
51 subjects
|
52 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 A/Uru/716/07 (N=64;67)
|
51 subjects
|
66 subjects
|
|
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 42 A/Uru/716/07 (N=64;67)
|
57 subjects
|
66 subjects
|
SECONDARY outcome
Timeframe: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 21 A/Cal/7/09 (N=64;67)
|
57 subjects
|
43 subjects
|
|
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 6 A/Cal/7/09 (N=60;63)
|
48 subjects
|
39 subjects
|
|
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 12 A/Cal/7/09 (N=60;64)
|
19 subjects
|
11 subjects
|
|
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63/Day 0 A/Bri/56/07 (N=63;67)
|
9 subjects
|
21 subjects
|
|
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63/Day 0 B/Bri/60/08 (N=63;67)
|
4 subjects
|
18 subjects
|
|
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63/Day 0 A/Uru/716/07 (N=63;67)
|
25 subjects
|
34 subjects
|
SECONDARY outcome
Timeframe: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
For the definition of seroconversion factor, please refer to the primary outcome measure. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 21 A/Cal/7/09 (N=64;67)
|
16.0 fold increase
Interval 12.2 to 21.0
|
7.9 fold increase
Interval 5.8 to 10.8
|
|
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 6 A/Cal/7/09 (N=60;63)
|
10.9 fold increase
Interval 8.5 to 14.1
|
5.2 fold increase
Interval 3.8 to 6.9
|
|
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 12 A/Cal/7/09 (N=60;64)
|
3.8 fold increase
Interval 2.9 to 5.0
|
1.8 fold increase
Interval 1.4 to 2.4
|
|
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63/Day 0 A/Bri/56/07 (N=63;67)
|
1.7 fold increase
Interval 1.4 to 2.1
|
3.1 fold increase
Interval 2.3 to 4.1
|
|
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63/Day 0 B/Bri/60/08 (N=63;67)
|
1.6 fold increase
Interval 1.4 to 1.8
|
2.6 fold increase
Interval 2.1 to 3.2
|
|
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63/Day 0 A/Uru/716/07 (N=63;67)
|
3.1 fold increase
Interval 2.5 to 4.0
|
4.5 fold increase
Interval 3.3 to 6.0
|
SECONDARY outcome
Timeframe: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=64 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=67 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 A/Cal/7/09 (N=64;67)
|
9 subjects
|
4 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 A/Cal/7/09 (N=64;67)
|
9 subjects
|
12 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 21 A/Cal/7/09 (N=64;67)
|
60 subjects
|
58 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 A/Cal/7/09 (N=63;66)
|
63 subjects
|
65 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 6 A/Cal/7/09 (N=60;63)
|
52 subjects
|
53 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Month 12 A/Cal/7/09 (N=60;64)
|
28 subjects
|
19 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 A/Bri/59/07 (N=64;67)
|
25 subjects
|
21 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 A/Bri/59/07 (N=64;67)
|
26 subjects
|
50 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 42 A/Bri/59/07 (N=64;67)
|
30 subjects
|
47 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 A/Bri/59/07 (N=63;66)
|
50 subjects
|
42 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 B/Bri/60/08 (N=64;67)
|
61 subjects
|
63 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 B/Bri/60/08 (N=64;67)
|
61 subjects
|
67 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 42 B/Bri/60/08 (N=64;67)
|
64 subjects
|
67 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 B/Bri/60/08 (N=63;66)
|
63 subjects
|
66 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day -21 A/Uru/716/07 (N=64;67)
|
30 subjects
|
22 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 0 A/Uru/716/07 (N=64;67)
|
29 subjects
|
57 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 42 A/Uru/716/07 (N=64;67)
|
30 subjects
|
47 subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Day 63 A/Uru/716/07 (N=63;66)
|
54 subjects
|
46 subjects
|
SECONDARY outcome
Timeframe: During a 7-Day (Day 0-6) follow-up period after each administration of PandemrixPopulation: The analysis was performed on the Total Vaccinated cohort on subjects with available results
Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=72 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=71 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Pain
|
49 subjects
|
43 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Redness
|
11 subjects
|
10 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Swelling
|
8 subjects
|
11 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Fatigue
|
22 subjects
|
18 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Headache
|
23 subjects
|
19 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Joint pain at other location
|
20 subjects
|
13 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Muscle aches
|
23 subjects
|
22 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Shivering
|
14 subjects
|
15 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Sweating
|
12 subjects
|
13 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Temperature
|
2 subjects
|
3 subjects
|
SECONDARY outcome
Timeframe: During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or FluarixPopulation: The analysis was performed on the Total Vaccinated cohort on subjects with available results.
Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius)
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=72 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=72 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
pain Day -21 (N=72;72)
|
5 subjects
|
12 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
redness Day -21 (N=72;72)
|
2 subjects
|
1 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
swelling Day -21 (N=72;72)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
pain Day 42 (N=69;71)
|
17 subjects
|
4 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
redness Day 42 (N=69;71)
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
swelling Day 42 (N=69;71)
|
2 subjects
|
0 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
fatigue Day -21 (N=72;72)
|
9 subjects
|
7 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
headache Day -21 (N=72;72)
|
5 subjects
|
10 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
joint pain at other location Day -21 (N=72;72)
|
7 subjects
|
2 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
muscle aches Day -21 (N=72;72)
|
4 subjects
|
6 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
shivering Day -21 (N=72;72)
|
2 subjects
|
4 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
sweating Day -21 (N=72;72)
|
5 subjects
|
6 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
temperature Day -21 (N=72;72)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
fatigue Day 42 (N=69;71)
|
10 subjects
|
4 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
headache Day 42 (N=69;71)
|
10 subjects
|
8 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
joint pain at other location Day 42 (N=69;71)
|
8 subjects
|
6 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
muscle aches Day 42 (N=69;71)
|
7 subjects
|
5 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
shivering Day 42 (N=69;71)
|
3 subjects
|
3 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
sweating Day -21 (N=69;71)
|
3 subjects
|
4 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
temperature Day 42 (N=69;71)
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: During 21 days (Day 0-20) after each vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort.
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: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=72 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=73 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any
|
33 subjects
|
37 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3
|
4 subjects
|
10 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related
|
14 subjects
|
9 subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0-364)Population: The analysis was performed on the Total Vaccinated cohort.
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.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=72 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=73 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
11 subjects
|
14 subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0-364)Population: The analysis was performed on the Total Vaccinated cohort.
Adverse events of specific interest included auto-immune diseases and other immune mediated disorders.
Outcome measures
| Measure |
Placebo-Pandemrix-Fluarix Group
n=72 Participants
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=73 Participants
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Number of Subjects With AEs of Specific Interest
|
0 subjects
|
1 subjects
|
Adverse Events
Placebo-Pandemrix-Fluarix Group
Serious events: 11 serious events
Other events: 59 other events
Deaths: 0 deaths
Fluarix-Pandemrix-Placebo Group
Serious events: 14 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Pandemrix-Fluarix Group
n=72 participants at risk
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=73 participants at risk
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
2.7%
2/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
2.7%
2/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Reproductive system and breast disorders
Breast mass
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
General disorders
Death
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Eye disorders
Eyelid ptosis
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Infections and infestations
Gastroenteritis norovirus
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Vascular disorders
Hypertensive crisis
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Cardiac disorders
myocardial infarction
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Nervous system disorders
Syncope
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
1/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
0.00%
0/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
1.4%
1/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
Other adverse events
| Measure |
Placebo-Pandemrix-Fluarix Group
n=72 participants at risk
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
|
Fluarix-Pandemrix-Placebo Group
n=73 participants at risk
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
|
|---|---|---|
|
General disorders
Pain
|
24.6%
17/69
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
16.7%
12/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
General disorders
Redness
|
15.3%
11/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
14.1%
10/71
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
General disorders
Swelling
|
11.1%
8/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
15.5%
11/71
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
General disorders
Fatigue
|
14.5%
10/69
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
9.7%
7/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
General disorders
Headache
|
14.5%
10/69
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
13.9%
10/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
General disorders
Joint pain at other location
|
11.6%
8/69
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
2.8%
2/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
General disorders
Muscle aches
|
10.1%
7/69
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
8.3%
6/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
General disorders
Shivering
|
4.3%
3/69
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
5.6%
4/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
General disorders
Sweating
|
4.3%
3/69
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
8.3%
6/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
|
Infections and infestations
Nasopharyngitis
|
15.3%
11/72
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
11.0%
8/73
Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
|
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