Trial Outcomes & Findings for Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults (NCT NCT00985673)
NCT ID: NCT00985673
Last Updated: 2018-08-01
Results Overview
The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
611 participants
Primary outcome timeframe
21 days after the second dose of Arepanrix vaccine (at Day 42).
Results posted on
2018-08-01
Participant Flow
Participant milestones
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
102
|
104
|
102
|
100
|
101
|
102
|
|
Overall Study
COMPLETED
|
95
|
93
|
90
|
88
|
93
|
96
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
12
|
12
|
8
|
6
|
Reasons for withdrawal
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
6
|
10
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
5
|
2
|
2
|
3
|
|
Overall Study
Other
|
1
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults
Baseline characteristics by cohort
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Total
n=611 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.7 Years
STANDARD_DEVIATION 6.20 • n=99 Participants
|
28.6 Years
STANDARD_DEVIATION 6.24 • n=107 Participants
|
28.2 Years
STANDARD_DEVIATION 6.32 • n=206 Participants
|
29.2 Years
STANDARD_DEVIATION 6.12 • n=7 Participants
|
29.3 Years
STANDARD_DEVIATION 6.47 • n=31 Participants
|
28.1 Years
STANDARD_DEVIATION 6.08 • n=30 Participants
|
28.9 Years
STANDARD_DEVIATION 6.2 • n=3 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
58 Participants
n=30 Participants
|
335 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
44 Participants
n=30 Participants
|
276 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 21 days after the second dose of Arepanrix vaccine (at Day 42).Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
|
—
|
—
|
—
|
589.8 Titers
Interval 517.8 to 671.8
|
—
|
933.1 Titers
Interval 815.6 to 1067.6
|
—
|
PRIMARY outcome
Timeframe: 21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42)Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
|
—
|
—
|
271.2 Titers
Interval 224.6 to 327.4
|
—
|
387.1 Titers
Interval 314.4 to 476.7
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 0, 7, 21, 28, 42, 63 and 182Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.
Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides. Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=27 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=27 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=27 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=25 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=28 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D0] (N=24,25,24,25,25,24)
|
3286.63 Number of T cells/million
Standard Deviation 1710.00
|
3531.36 Number of T cells/million
Standard Deviation 1972.37
|
4315.71 Number of T cells/million
Standard Deviation 2499.77
|
3056.80 Number of T cells/million
Standard Deviation 1096.38
|
3308.08 Number of T cells/million
Standard Deviation 1124.49
|
2775.50 Number of T cells/million
Standard Deviation 1214.18
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D0] (N=25,25,24,25,25,26)
|
2533.40 Number of T cells/million
Standard Deviation 1225.90
|
2604.64 Number of T cells/million
Standard Deviation 1435.48
|
3521.33 Number of T cells/million
Standard Deviation 1922.24
|
2612.56 Number of T cells/million
Standard Deviation 1256.47
|
2644.40 Number of T cells/million
Standard Deviation 1219.04
|
2016.31 Number of T cells/million
Standard Deviation 822.34
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D7] (N=24,27,24,23,24,26)
|
4437.33 Number of T cells/million
Standard Deviation 1930.30
|
4595.26 Number of T cells/million
Standard Deviation 2058.76
|
5560.33 Number of T cells/million
Standard Deviation 3301.90
|
6242.30 Number of T cells/million
Standard Deviation 2773.60
|
4269.96 Number of T cells/million
Standard Deviation 1744.37
|
4674.88 Number of T cells/million
Standard Deviation 2325.77
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D21] (N=26,25,27,24,24,26)
|
3561.00 Number of T cells/million
Standard Deviation 1502.24
|
3756.72 Number of T cells/million
Standard Deviation 1379.69
|
5581.78 Number of T cells/million
Standard Deviation 3123.38
|
6069.67 Number of T cells/million
Standard Deviation 3306.79
|
3894.54 Number of T cells/million
Standard Deviation 1596.44
|
5590.23 Number of T cells/million
Standard Deviation 2407.32
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D28] (N=27,27,27,26,25,27)
|
3500.22 Number of T cells/million
Standard Deviation 1615.89
|
4269.11 Number of T cells/million
Standard Deviation 1482.01
|
5102.78 Number of T cells/million
Standard Deviation 2856.77
|
6989.15 Number of T cells/million
Standard Deviation 3950.45
|
3816.20 Number of T cells/million
Standard Deviation 1290.25
|
7083.19 Number of T cells/million
Standard Deviation 3227.04
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D42] (N=27,26,27,27,24,28)
|
3595.11 Number of T cells/million
Standard Deviation 1268.17
|
5246.88 Number of T cells/million
Standard Deviation 2407.94
|
4791.41 Number of T cells/million
Standard Deviation 2706.43
|
5607.96 Number of T cells/million
Standard Deviation 2773.17
|
3872.67 Number of T cells/million
Standard Deviation 1270.26
|
6200.64 Number of T cells/million
Standard Deviation 2733.75
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D63] (N=26,26,25,25,24,26)
|
3407.62 Number of T cells/million
Standard Deviation 1114.62
|
6444.50 Number of T cells/million
Standard Deviation 2681.50
|
4169.32 Number of T cells/million
Standard Deviation 2216.49
|
5020.88 Number of T cells/million
Standard Deviation 2346.39
|
4074.38 Number of T cells/million
Standard Deviation 1639.45
|
5757.04 Number of T cells/million
Standard Deviation 3131.86
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D182] (N=26,24,26,26,25,25)
|
3190.31 Number of T cells/million
Standard Deviation 1086.38
|
4631.00 Number of T cells/million
Standard Deviation 1834.57
|
4132.81 Number of T cells/million
Standard Deviation 1816.70
|
3988.04 Number of T cells/million
Standard Deviation 1606.16
|
3672.16 Number of T cells/million
Standard Deviation 1191.85
|
4568.16 Number of T cells/million
Standard Deviation 2043.61
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D0] (N=25,25,24,25,25,26)
|
2176.28 Number of T cells/million
Standard Deviation 1226.08
|
1988.24 Number of T cells/million
Standard Deviation 1072.73
|
2804.63 Number of T cells/million
Standard Deviation 1912.94
|
2055.44 Number of T cells/million
Standard Deviation 1053.95
|
2109.52 Number of T cells/million
Standard Deviation 828.11
|
1641.04 Number of T cells/million
Standard Deviation 799.39
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D7] (N=24,27,24,23,24,26)
|
4089.25 Number of T cells/million
Standard Deviation 2131.69
|
3852.44 Number of T cells/million
Standard Deviation 1970.35
|
4780.21 Number of T cells/million
Standard Deviation 2828.25
|
5265.74 Number of T cells/million
Standard Deviation 2008.41
|
3224.42 Number of T cells/million
Standard Deviation 1238.08
|
3590.08 Number of T cells/million
Standard Deviation 1912.94
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D21] (N=26,25,27,24,24,26)
|
3144.62 Number of T cells/million
Standard Deviation 1723.51
|
3032.52 Number of T cells/million
Standard Deviation 1342.30
|
4455.00 Number of T cells/million
Standard Deviation 2768.12
|
4986.71 Number of T cells/million
Standard Deviation 2398.42
|
2975.38 Number of T cells/million
Standard Deviation 1058.31
|
4793.35 Number of T cells/million
Standard Deviation 2194.74
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D28] (N=27,27,27,26,25,27)
|
3061.63 Number of T cells/million
Standard Deviation 1632.58
|
3770.44 Number of T cells/million
Standard Deviation 1460.62
|
4058.63 Number of T cells/million
Standard Deviation 2349.19
|
5979.12 Number of T cells/million
Standard Deviation 3448.84
|
2875.52 Number of T cells/million
Standard Deviation 837.73
|
6689.44 Number of T cells/million
Standard Deviation 3501.59
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D42] (N=27,27,27,27,24,28)
|
2931.04 Number of T cells/million
Standard Deviation 1276.42
|
4381.48 Number of T cells/million
Standard Deviation 2053.51
|
3720.07 Number of T cells/million
Standard Deviation 2261.08
|
4658.07 Number of T cells/million
Standard Deviation 1939.82
|
2838.00 Number of T cells/million
Standard Deviation 1008.20
|
5622.14 Number of T cells/million
Standard Deviation 2870.26
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D63] (N=26,26,25,25,24,26)
|
2768.15 Number of T cells/million
Standard Deviation 1109.96
|
5328.19 Number of T cells/million
Standard Deviation 2436.59
|
3149.00 Number of T cells/million
Standard Deviation 1844.25
|
3967.12 Number of T cells/million
Standard Deviation 1655.09
|
3246.71 Number of T cells/million
Standard Deviation 1379.49
|
5151.62 Number of T cells/million
Standard Deviation 3008.33
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D182] (N=26,24,26,26,25,25)
|
1461.88 Number of T cells/million
Standard Deviation 735.77
|
2333.88 Number of T cells/million
Standard Deviation 925.38
|
1838.96 Number of T cells/million
Standard Deviation 842.26
|
2068.73 Number of T cells/million
Standard Deviation 939.92
|
1630.40 Number of T cells/million
Standard Deviation 592.23
|
2513.48 Number of T cells/million
Standard Deviation 1232.20
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D0] (N=25,24,24,25,23,25)
|
349.64 Number of T cells/million
Standard Deviation 336.13
|
428.00 Number of T cells/million
Standard Deviation 296.76
|
356.79 Number of T cells/million
Standard Deviation 206.44
|
320.52 Number of T cells/million
Standard Deviation 216.19
|
443.35 Number of T cells/million
Standard Deviation 356.02
|
271.76 Number of T cells/million
Standard Deviation 180.44
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D7] (N=24,27,24,23,24,25)
|
596.42 Number of T cells/million
Standard Deviation 500.15
|
581.63 Number of T cells/million
Standard Deviation 527.07
|
708.96 Number of T cells/million
Standard Deviation 518.87
|
857.04 Number of T cells/million
Standard Deviation 474.48
|
692.29 Number of T cells/million
Standard Deviation 454.48
|
718.76 Number of T cells/million
Standard Deviation 663.81
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D21] (N=26,24,27,24,24,26)
|
465.42 Number of T cells/million
Standard Deviation 352.18
|
589.79 Number of T cells/million
Standard Deviation 459.57
|
728.15 Number of T cells/million
Standard Deviation 623.89
|
974.67 Number of T cells/million
Standard Deviation 579.23
|
619.50 Number of T cells/million
Standard Deviation 391.47
|
1022.38 Number of T cells/million
Standard Deviation 572.50
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D28] (N=26,27,27,26,25,27)
|
480.42 Number of T cells/million
Standard Deviation 392.81
|
704.59 Number of T cells/million
Standard Deviation 518.63
|
528.78 Number of T cells/million
Standard Deviation 322.10
|
1345.69 Number of T cells/million
Standard Deviation 1536.94
|
642.00 Number of T cells/million
Standard Deviation 379.90
|
1251.07 Number of T cells/million
Standard Deviation 695.04
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D42] (N=27,27,27,27,24,28)
|
467.70 Number of T cells/million
Standard Deviation 302.91
|
1049.96 Number of T cells/million
Standard Deviation 865.58
|
514.78 Number of T cells/million
Standard Deviation 296.67
|
1080.93 Number of T cells/million
Standard Deviation 669.26
|
600.04 Number of T cells/million
Standard Deviation 496.71
|
1228.25 Number of T cells/million
Standard Deviation 637.35
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D63] (N=26,26,25,25,24,26)
|
504.92 Number of T cells/million
Standard Deviation 321.17
|
1248.54 Number of T cells/million
Standard Deviation 1175.35
|
460.28 Number of T cells/million
Standard Deviation 267.85
|
815.24 Number of T cells/million
Standard Deviation 634.45
|
508.58 Number of T cells/million
Standard Deviation 316.75
|
910.81 Number of T cells/million
Standard Deviation 482.86
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D182] (N=26,24,26,26,25,25)
|
554.65 Number of T cells/million
Standard Deviation 439.30
|
824.17 Number of T cells/million
Standard Deviation 565.53
|
531.73 Number of T cells/million
Standard Deviation 481.91
|
648.69 Number of T cells/million
Standard Deviation 557.34
|
552.52 Number of T cells/million
Standard Deviation 528.46
|
757.68 Number of T cells/million
Standard Deviation 638.40
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D7] (N=24,27,24,23,24,25)
|
6574.50 Number of T cells/million
Standard Deviation 3399.35
|
6921.85 Number of T cells/million
Standard Deviation 4366.14
|
7096.46 Number of T cells/million
Standard Deviation 3777.79
|
7682.43 Number of T cells/million
Standard Deviation 2951.47
|
4668.17 Number of T cells/million
Standard Deviation 1675.47
|
4713.28 Number of T cells/million
Standard Deviation 2161.14
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D21] (N=25,25,27,24,24,25)
|
5234.16 Number of T cells/million
Standard Deviation 2513.78
|
5124.60 Number of T cells/million
Standard Deviation 2268.53
|
6579.26 Number of T cells/million
Standard Deviation 3489.20
|
6949.96 Number of T cells/million
Standard Deviation 3006.25
|
4329.96 Number of T cells/million
Standard Deviation 1672.20
|
5691.08 Number of T cells/million
Standard Deviation 2047.10
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D28] (N=25,27,27,26,25,26)
|
4767.36 Number of T cells/million
Standard Deviation 2217.82
|
5256.07 Number of T cells/million
Standard Deviation 2292.16
|
6090.00 Number of T cells/million
Standard Deviation 3336.49
|
7265.23 Number of T cells/million
Standard Deviation 3520.63
|
4047.92 Number of T cells/million
Standard Deviation 1219.00
|
6804.42 Number of T cells/million
Standard Deviation 2824.80
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D42] (N=26,27,27,26,24,27)
|
4734.42 Number of T cells/million
Standard Deviation 1823.28
|
5881.78 Number of T cells/million
Standard Deviation 2641.14
|
5721.70 Number of T cells/million
Standard Deviation 3058.63
|
6239.38 Number of T cells/million
Standard Deviation 2542.17
|
4167.63 Number of T cells/million
Standard Deviation 1351.74
|
6215.93 Number of T cells/million
Standard Deviation 2389.59
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D63] (N=25,26,25,25,24,24)
|
4405.96 Number of T cells/million
Standard Deviation 1586.42
|
6639.92 Number of T cells/million
Standard Deviation 3131.66
|
4893.88 Number of T cells/million
Standard Deviation 2322.10
|
5323.84 Number of T cells/million
Standard Deviation 2132.52
|
4900.17 Number of T cells/million
Standard Deviation 2016.61
|
6455.25 Number of T cells/million
Standard Deviation 2694.48
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D182] (N=26,24,26,26,25,25)
|
3304.50 Number of T cells/million
Standard Deviation 1393.44
|
4325.63 Number of T cells/million
Standard Deviation 1541.34
|
4006.46 Number of T cells/million
Standard Deviation 1836.30
|
3937.67 Number of T cells/million
Standard Deviation 1413.94
|
3918.28 Number of T cells/million
Standard Deviation 1284.32
|
4277.76 Number of T cells/million
Standard Deviation 1655.16
|
—
|
SECONDARY outcome
Timeframe: On Days 0, 7, 21, 28, 42, 63 and 182Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.
Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides. Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=27 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=27 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=27 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=25 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=28 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D42] (N=26,27,27,26,24,27)
|
506.35 Number of T cells/million
Standard Deviation 560.83
|
356.41 Number of T cells/million
Standard Deviation 392.23
|
471.30 Number of T cells/million
Standard Deviation 610.38
|
344.77 Number of T cells/million
Standard Deviation 709.66
|
996.67 Number of T cells/million
Standard Deviation 3648.68
|
391.11 Number of T cells/million
Standard Deviation 755.53
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D0] (N=25,25,24,25,25,26)
|
515.36 Number of T cells/million
Standard Deviation 1191.10
|
382.84 Number of T cells/million
Standard Deviation 595.58
|
489.08 Number of T cells/million
Standard Deviation 520.30
|
183.96 Number of T cells/million
Standard Deviation 226.54
|
1222.40 Number of T cells/million
Standard Deviation 4485.04
|
119.46 Number of T cells/million
Standard Deviation 113.79
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D7] (N=24,27,24,23,24,26)
|
772.96 Number of T cells/million
Standard Deviation 716.40
|
884.81 Number of T cells/million
Standard Deviation 1225.90
|
1115.96 Number of T cells/million
Standard Deviation 1545.07
|
725.39 Number of T cells/million
Standard Deviation 585.98
|
1611.96 Number of T cells/million
Standard Deviation 4894.45
|
529.73 Number of T cells/million
Standard Deviation 416.76
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D21] (N=26,25,27,24,24,26)
|
601.31 Number of T cells/million
Standard Deviation 1154.73
|
517.44 Number of T cells/million
Standard Deviation 799.20
|
655.22 Number of T cells/million
Standard Deviation 1327.00
|
319.17 Number of T cells/million
Standard Deviation 315.86
|
1184.17 Number of T cells/million
Standard Deviation 4146.13
|
501.08 Number of T cells/million
Standard Deviation 1319.91
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D28] (N=27,27,27,26,25,27)
|
629.22 Number of T cells/million
Standard Deviation 964.11
|
642.22 Number of T cells/million
Standard Deviation 850.79
|
498.33 Number of T cells/million
Standard Deviation 730.34
|
508.88 Number of T cells/million
Standard Deviation 540.73
|
1466.76 Number of T cells/million
Standard Deviation 5768.96
|
1735.48 Number of T cells/million
Standard Deviation 5219.43
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D42] (N=27,26,27,27,24,28)
|
666.67 Number of T cells/million
Standard Deviation 1180.05
|
551.88 Number of T cells/million
Standard Deviation 911.02
|
525.07 Number of T cells/million
Standard Deviation 938.18
|
209.07 Number of T cells/million
Standard Deviation 171.21
|
1737.50 Number of T cells/million
Standard Deviation 6861.67
|
501.54 Number of T cells/million
Standard Deviation 1329.90
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D63] (N=26,26,25,25,24,26)
|
620.00 Number of T cells/million
Standard Deviation 1393.77
|
420.50 Number of T cells/million
Standard Deviation 486.62
|
428.92 Number of T cells/million
Standard Deviation 687.17
|
230.84 Number of T cells/million
Standard Deviation 226.10
|
1493.46 Number of T cells/million
Standard Deviation 5828.76
|
529.81 Number of T cells/million
Standard Deviation 1383.73
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/Brisbane [D182] (N=26,24,26,26,25,25)
|
550.27 Number of T cells/million
Standard Deviation 1948.06
|
436.79 Number of T cells/million
Standard Deviation 653.50
|
377.65 Number of T cells/million
Standard Deviation 426.59
|
86.81 Number of T cells/million
Standard Deviation 99.38
|
1474.56 Number of T cells/million
Standard Deviation 6012.19
|
370.64 Number of T cells/million
Standard Deviation 955.57
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D0] (N=25,25,24,25,25,26)
|
357.40 Number of T cells/million
Standard Deviation 800.46
|
189.28 Number of T cells/million
Standard Deviation 197.92
|
271.58 Number of T cells/million
Standard Deviation 192.68
|
365.72 Number of T cells/million
Standard Deviation 985.87
|
482.64 Number of T cells/million
Standard Deviation 1286.27
|
93.50 Number of T cells/million
Standard Deviation 114.90
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D7] (N=24,27,24,23,24,26)
|
610.29 Number of T cells/million
Standard Deviation 744.70
|
466.93 Number of T cells/million
Standard Deviation 573.69
|
716.88 Number of T cells/million
Standard Deviation 1251.20
|
553.78 Number of T cells/million
Standard Deviation 639.15
|
834.50 Number of T cells/million
Standard Deviation 2063.34
|
348.69 Number of T cells/million
Standard Deviation 326.74
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D21] (N=26,25,27,24,24,26)
|
332.00 Number of T cells/million
Standard Deviation 539.48
|
275.04 Number of T cells/million
Standard Deviation 334.83
|
324.37 Number of T cells/million
Standard Deviation 668.77
|
183.00 Number of T cells/million
Standard Deviation 146.43
|
428.92 Number of T cells/million
Standard Deviation 1071.57
|
351.69 Number of T cells/million
Standard Deviation 713.52
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D28] (N=27,27,27,26,25,27)
|
470.33 Number of T cells/million
Standard Deviation 655.02
|
452.93 Number of T cells/million
Standard Deviation 547.61
|
332.63 Number of T cells/million
Standard Deviation 553.07
|
344.54 Number of T cells/million
Standard Deviation 288.96
|
973.96 Number of T cells/million
Standard Deviation 3644.93
|
497.67 Number of T cells/million
Standard Deviation 612.95
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D42] (N=27,27,27,27,24,28)
|
314.89 Number of T cells/million
Standard Deviation 289.95
|
304.00 Number of T cells/million
Standard Deviation 255.38
|
247.89 Number of T cells/million
Standard Deviation 459.58
|
157.67 Number of T cells/million
Standard Deviation 192.15
|
702.50 Number of T cells/million
Standard Deviation 2209.62
|
291.96 Number of T cells/million
Standard Deviation 654.16
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D63] (N=26,2625,25,24,26)
|
203.62 Number of T cells/million
Standard Deviation 197.89
|
260.54 Number of T cells/million
Standard Deviation 359.88
|
242.36 Number of T cells/million
Standard Deviation 357.21
|
114.24 Number of T cells/million
Standard Deviation 165.15
|
853.83 Number of T cells/million
Standard Deviation 3236.11
|
194.73 Number of T cells/million
Standard Deviation 453.09
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
A/California [D182] (N=26,24,26,26,25,25)
|
214.85 Number of T cells/million
Standard Deviation 326.43
|
220.71 Number of T cells/million
Standard Deviation 330.88
|
225.50 Number of T cells/million
Standard Deviation 366.51
|
139.50 Number of T cells/million
Standard Deviation 273.43
|
598.92 Number of T cells/million
Standard Deviation 2344.64
|
138.52 Number of T cells/million
Standard Deviation 245.14
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D0] (N=25,24,24,25,23,25)
|
110.48 Number of T cells/million
Standard Deviation 140.31
|
180.38 Number of T cells/million
Standard Deviation 359.58
|
101.04 Number of T cells/million
Standard Deviation 158.31
|
150.08 Number of T cells/million
Standard Deviation 215.56
|
111.26 Number of T cells/million
Standard Deviation 162.75
|
70.92 Number of T cells/million
Standard Deviation 113.24
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D7] (N=24,27,24,23,24,25)
|
205.33 Number of T cells/million
Standard Deviation 288.67
|
185.15 Number of T cells/million
Standard Deviation 243.88
|
202.13 Number of T cells/million
Standard Deviation 293.11
|
254.65 Number of T cells/million
Standard Deviation 417.53
|
243.46 Number of T cells/million
Standard Deviation 382.39
|
173.48 Number of T cells/million
Standard Deviation 202.67
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D21] (N=26,24,27,24,24,26)
|
103.81 Number of T cells/million
Standard Deviation 160.76
|
194.92 Number of T cells/million
Standard Deviation 384.18
|
101.30 Number of T cells/million
Standard Deviation 148.62
|
140.75 Number of T cells/million
Standard Deviation 155.63
|
211.96 Number of T cells/million
Standard Deviation 482.54
|
173.77 Number of T cells/million
Standard Deviation 432.74
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D28] (N=26,27,27,26,25,27)
|
100.08 Number of T cells/million
Standard Deviation 132.13
|
170.04 Number of T cells/million
Standard Deviation 385.99
|
124.56 Number of T cells/million
Standard Deviation 181.86
|
277.77 Number of T cells/million
Standard Deviation 329.71
|
160.80 Number of T cells/million
Standard Deviation 216.87
|
187.37 Number of T cells/million
Standard Deviation 361.53
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D42] (N=27,27,27,27,24,28)
|
143.67 Number of T cells/million
Standard Deviation 189.28
|
157.41 Number of T cells/million
Standard Deviation 350.83
|
87.41 Number of T cells/million
Standard Deviation 115.12
|
103.89 Number of T cells/million
Standard Deviation 139.95
|
266.75 Number of T cells/million
Standard Deviation 481.50
|
145.96 Number of T cells/million
Standard Deviation 261.67
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D63] (N=26,26,25,25,24,26)
|
85.96 Number of T cells/million
Standard Deviation 97.66
|
173.88 Number of T cells/million
Standard Deviation 244.91
|
113.20 Number of T cells/million
Standard Deviation 193.78
|
88.28 Number of T cells/million
Standard Deviation 162.10
|
210.33 Number of T cells/million
Standard Deviation 403.19
|
88.19 Number of T cells/million
Standard Deviation 206.24
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool peptides H1 [D182] (N=26,24,26,26,25,25)
|
287.31 Number of T cells/million
Standard Deviation 511.19
|
265.63 Number of T cells/million
Standard Deviation 343.36
|
306.04 Number of T cells/million
Standard Deviation 630.16
|
241.42 Number of T cells/million
Standard Deviation 353.02
|
255.44 Number of T cells/million
Standard Deviation 425.71
|
198.44 Number of T cells/million
Standard Deviation 561.99
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D0] (N=24,25,24,25,25,24)
|
351.38 Number of T cells/million
Standard Deviation 467.93
|
224.60 Number of T cells/million
Standard Deviation 251.59
|
478.42 Number of T cells/million
Standard Deviation 463.43
|
344.60 Number of T cells/million
Standard Deviation 641.98
|
761.68 Number of T cells/million
Standard Deviation 2411.00
|
157.63 Number of T cells/million
Standard Deviation 166.45
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D7] (N=24,27,24,23,24,25)
|
986.92 Number of T cells/million
Standard Deviation 863.16
|
843.44 Number of T cells/million
Standard Deviation 826.65
|
1042.17 Number of T cells/million
Standard Deviation 1237.44
|
788.78 Number of T cells/million
Standard Deviation 947.53
|
1094.96 Number of T cells/million
Standard Deviation 3111.41
|
522.84 Number of T cells/million
Standard Deviation 514.35
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D21] (N=25,25,27,24,24,25)
|
586.32 Number of T cells/million
Standard Deviation 876.08
|
268.24 Number of T cells/million
Standard Deviation 324.48
|
609.07 Number of T cells/million
Standard Deviation 997.10
|
266.63 Number of T cells/million
Standard Deviation 252.28
|
693.88 Number of T cells/million
Standard Deviation 2082.82
|
406.28 Number of T cells/million
Standard Deviation 620.10
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D28] (N=25,27,27,26,25,26)
|
484.48 Number of T cells/million
Standard Deviation 587.46
|
508.11 Number of T cells/million
Standard Deviation 559.97
|
505.33 Number of T cells/million
Standard Deviation 595.15
|
458.12 Number of T cells/million
Standard Deviation 496.69
|
963.20 Number of T cells/million
Standard Deviation 3548.16
|
423.62 Number of T cells/million
Standard Deviation 430.29
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D63] (N=25,26,25,25,24,24)
|
461.20 Number of T cells/million
Standard Deviation 698.48
|
325.12 Number of T cells/million
Standard Deviation 270.84
|
402.24 Number of T cells/million
Standard Deviation 418.89
|
296.08 Number of T cells/million
Standard Deviation 624.75
|
1123.13 Number of T cells/million
Standard Deviation 4008.27
|
432.08 Number of T cells/million
Standard Deviation 1145.71
|
—
|
|
Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).
Pool Flu [D182] (N=26,24,26,26,25,25)
|
404.77 Number of T cells/million
Standard Deviation 981.01
|
315.75 Number of T cells/million
Standard Deviation 441.50
|
334.23 Number of T cells/million
Standard Deviation 447.12
|
291.73 Number of T cells/million
Standard Deviation 790.15
|
926.40 Number of T cells/million
Standard Deviation 3463.27
|
234.92 Number of T cells/million
Standard Deviation 398.06
|
—
|
SECONDARY outcome
Timeframe: On Days 0, 7, 21, 28, 42, 63 and 182Population: The Total Vaccinated Cohort included all vaccinated subjects.
Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D21] Below (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D42] Above (N=101,97,95,95,96,97)
|
3 Subjects
|
4 Subjects
|
2 Subjects
|
4 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D63] Unknown (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D42] Below (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D42] Within (N=101,97,95,95,96,97)
|
101 Subjects
|
97 Subjects
|
95 Subjects
|
95 Subjects
|
96 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D63] Unknown (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D182] Unknown (N=99,91,88,91,93,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D0] Unknown (N=102,104,102,100,101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D28] Unknown (N=101,98,96,98,98,97)
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D0] Unknown (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D0] Below (N=102,101,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D0] Within (N=102,101,102,100,101,102)
|
100 Subjects
|
101 Subjects
|
99 Subjects
|
95 Subjects
|
100 Subjects
|
99 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D0] Above (N=102,101,102,100,101,102)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
4 Subjects
|
0 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D7] Below (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D7] Within (N=102,101,100,99,100,99)
|
100 Subjects
|
96 Subjects
|
99 Subjects
|
97 Subjects
|
100 Subjects
|
98 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D7] Above (N=102,101,100,99,100,99)
|
2 Subjects
|
5 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D21] Within (N=101,100,97,97,99,99)
|
96 Subjects
|
97 Subjects
|
96 Subjects
|
96 Subjects
|
96 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D21] Above (N=101,100,97,97,99,99)
|
5 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D28] Below (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D28] Within (N=101,98,96,98,98,97)
|
96 Subjects
|
96 Subjects
|
94 Subjects
|
93 Subjects
|
96 Subjects
|
92 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D28] Above (N=101,98,96,98,98,97)
|
4 Subjects
|
2 Subjects
|
2 Subjects
|
4 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D42] Below (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D42] Within (N=101,97,95,95,96,97)
|
97 Subjects
|
94 Subjects
|
93 Subjects
|
94 Subjects
|
92 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D42] Above (N=101,97,95,95,96,97)
|
4 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D63] Below (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D63] Within (N=100,95,95,95,97,97)
|
93 Subjects
|
89 Subjects
|
93 Subjects
|
95 Subjects
|
93 Subjects
|
92 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D63] Above (N=100,95,95,95,97,97)
|
6 Subjects
|
5 Subjects
|
1 Subjects
|
0 Subjects
|
3 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D182] Below (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D182] Within (N=99,91,88,91,93,97)
|
97 Subjects
|
89 Subjects
|
88 Subjects
|
90 Subjects
|
91 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D182] Above (N=99,91,88,91,93,97)
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D0] Below (N=102,104, 102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D0] Within (N=102,104, 102,100,101,102)
|
102 Subjects
|
104 Subjects
|
100 Subjects
|
98 Subjects
|
99 Subjects
|
101 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D0] Above (N=102,104, 102,100,101,102)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D7] Below (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D7] Within (N=102,101,100,99,100,99)
|
101 Subjects
|
101 Subjects
|
100 Subjects
|
98 Subjects
|
99 Subjects
|
98 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D7] Above (N=102,101,100,99,100,99)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D21] Below (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D21] Within (N=101,100,97,97,99,99)
|
101 Subjects
|
100 Subjects
|
96 Subjects
|
96 Subjects
|
97 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D21] Above (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D28] Below (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D28] Within (N=101,98,96,98,98,97)
|
99 Subjects
|
97 Subjects
|
95 Subjects
|
95 Subjects
|
98 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D28] Above (N=101,98,96,98,98,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D42] Below (N=101,97, 95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D42] Within (N=101,97, 95,95,96,97)
|
99 Subjects
|
97 Subjects
|
94 Subjects
|
92 Subjects
|
93 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D42] Above (N=101,97, 95,95,96,97)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D63] Below (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D63] Within (N=100,95,95,95,97,97)
|
99 Subjects
|
94 Subjects
|
93 Subjects
|
92 Subjects
|
95 Subjects
|
94 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D182] Below (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D182] Within (N=99,91,88,91,93,97)
|
98 Subjects
|
90 Subjects
|
88 Subjects
|
90 Subjects
|
89 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D182] Above (N=99,91,88,91,93,97)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D0] Below (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D0] Within (N=102,104,102,100,101,102)
|
101 Subjects
|
102 Subjects
|
100 Subjects
|
98 Subjects
|
99 Subjects
|
101 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D0] Above (N=102,104,102,100,101,102)
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D7] Below (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D7] Within (N=102,101,100,99,100,99)
|
99 Subjects
|
99 Subjects
|
97 Subjects
|
99 Subjects
|
99 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D7] Above (N=102,101,100,99,100,99)
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D21] Below (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D21] Within (N=101,100,97,97,99,99)
|
99 Subjects
|
99 Subjects
|
97 Subjects
|
97 Subjects
|
98 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D21] Above (N=101,100,97,97,99,99)
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D28] Below (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D28] Within (N=101,98,96,98,98,97)
|
96 Subjects
|
97 Subjects
|
93 Subjects
|
95 Subjects
|
98 Subjects
|
93 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D28] Above (N=101,98,96,98,98,97)
|
4 Subjects
|
1 Subjects
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D42] Below (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D42] Within (N=101,97,95,95,96,97)
|
95 Subjects
|
95 Subjects
|
93 Subjects
|
95 Subjects
|
94 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D42] Above (N=101,97,95,95,96,97)
|
6 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D63] Below (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D63] Within (N=100,95,95,95,97,97)
|
98 Subjects
|
94 Subjects
|
92 Subjects
|
94 Subjects
|
95 Subjects
|
93 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D63] Above (N=100,95,95,95,97,97)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D182] Below (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D182] Within (N=99,91,88,91,93,97)
|
96 Subjects
|
86 Subjects
|
87 Subjects
|
88 Subjects
|
91 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D182] Above (N=99,91,88,91,93,97)
|
2 Subjects
|
4 Subjects
|
0 Subjects
|
3 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D0] Below (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D0] Within (N=102,104,102,100,101,102)
|
100 Subjects
|
104 Subjects
|
102 Subjects
|
98 Subjects
|
101 Subjects
|
102 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D0] Above (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D7] Below (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D7] Within (N=102,101,100,99,100,99)
|
102 Subjects
|
100 Subjects
|
100 Subjects
|
98 Subjects
|
100 Subjects
|
99 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D7] Above (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D21] Below (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D21] Within (N=101,100,97,97,99,99)
|
101 Subjects
|
99 Subjects
|
94 Subjects
|
96 Subjects
|
97 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D21] Above (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D28] Below (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D28] Within (N=101,98,96,98,98,97)
|
99 Subjects
|
96 Subjects
|
96 Subjects
|
96 Subjects
|
97 Subjects
|
94 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D63] Below (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D63] Within (N=100,95,95,95,97,97)
|
100 Subjects
|
95 Subjects
|
95 Subjects
|
95 Subjects
|
97 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D182] Below (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D182] Within (N=99,91,88,91,93,97)
|
99 Subjects
|
91 Subjects
|
88 Subjects
|
89 Subjects
|
93 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BAS [D182] Above (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D0] Below (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D0] Within (N=102,104,102,100,101,102)
|
101 Subjects
|
102 Subjects
|
100 Subjects
|
98 Subjects
|
99 Subjects
|
101 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D0] Above (N=102,104,102,100,101,102)
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D7] Below (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D7] Within (N=102,101,100,99,100,99)
|
101 Subjects
|
100 Subjects
|
97 Subjects
|
98 Subjects
|
99 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D7] Above (N=102,101,100,99,100,99)
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D21] Below (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D21] Within (N=101,100,97,97,99,99)
|
99 Subjects
|
97 Subjects
|
95 Subjects
|
96 Subjects
|
97 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D21] Above (N=101,100,97,97,99,99)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D28] Below (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D28] Within (N=101,98,96,98,98,97)
|
99 Subjects
|
96 Subjects
|
94 Subjects
|
95 Subjects
|
97 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D28] Above (N=101,98,96,98,98,97)
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D42] Below (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D42] Within (N=101,97,95,95,96,97)
|
98 Subjects
|
93 Subjects
|
92 Subjects
|
91 Subjects
|
93 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D63] Below (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D63] Within (N=100,95,95,95,97,97)
|
98 Subjects
|
92 Subjects
|
92 Subjects
|
94 Subjects
|
93 Subjects
|
94 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D63] Above (N=100,95,95,95,97,97)
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D182] Below (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D182] Within (N=99,91,88,91,93,97)
|
99 Subjects
|
87 Subjects
|
86 Subjects
|
89 Subjects
|
90 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL T [D182] Above (N=99,91,88,91,93,97)
|
0 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D0] Unknown (N=102,101,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D63] Unknown (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ALAT [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D0] Unknown (N=102,104, 102,100,101,102)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D42] Unknown (N=101,97, 95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D63] Unknown (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
AP [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D0] Unknown (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
ASAT [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
SECONDARY outcome
Timeframe: On Days 0, 7, 21, 28, 42, 63 and 182Population: The Total Vaccinated cohort included all vaccinated subjects
Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D63] Unknown (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D182] Below (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D0] Unknown (N=102,104,102,100,101,102)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D7] Above (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D63] Below (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D42] Below (N=101,97,95,95,96,97)
|
6 Subjects
|
5 Subjects
|
5 Subjects
|
10 Subjects
|
9 Subjects
|
11 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D42] Within (N=101,97,95,95,96,97)
|
95 Subjects
|
90 Subjects
|
88 Subjects
|
84 Subjects
|
85 Subjects
|
86 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D63] Below (N=100,95,95,95,97,97)
|
7 Subjects
|
7 Subjects
|
7 Subjects
|
14 Subjects
|
7 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D182] Within (N=99,91,88,91,93,97)
|
84 Subjects
|
82 Subjects
|
80 Subjects
|
81 Subjects
|
86 Subjects
|
83 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D182] Above (N=99,91,88,91,93,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D0] Within (N=102,104,102,100,101,102)
|
97 Subjects
|
96 Subjects
|
93 Subjects
|
92 Subjects
|
90 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D0] Unknown (N=102,104,102,100,101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D7] Below (N=102,101,100,99,100,99)
|
7 Subjects
|
4 Subjects
|
7 Subjects
|
1 Subjects
|
5 Subjects
|
8 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D7] Above (N=102,101,100,99,100,99)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D28] Within (N=101,98,96,98,98,97)
|
94 Subjects
|
90 Subjects
|
89 Subjects
|
93 Subjects
|
90 Subjects
|
87 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D28] Above (N=101,98,96,98,98,97)
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D28] Unknown (N=101,98,96,98,98,97)
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D63] Below (N=100,95,95,95,97,97)
|
2 Subjects
|
9 Subjects
|
8 Subjects
|
4 Subjects
|
8 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D182] Within (N=99,91,88,91,93,97)
|
94 Subjects
|
86 Subjects
|
78 Subjects
|
83 Subjects
|
84 Subjects
|
89 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D0] Below (N=102,104,102,100,101,102)
|
4 Subjects
|
2 Subjects
|
4 Subjects
|
3 Subjects
|
3 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D7] Below (N=102,101,100,99,100,99)
|
7 Subjects
|
7 Subjects
|
4 Subjects
|
4 Subjects
|
3 Subjects
|
6 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D21] Below (N=101,100,97,97,99,99)
|
8 Subjects
|
4 Subjects
|
5 Subjects
|
8 Subjects
|
6 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D21] Above (N=101,100,97,97,99,99)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D63] Within (N=100,95,95,95,97,97)
|
92 Subjects
|
84 Subjects
|
84 Subjects
|
89 Subjects
|
87 Subjects
|
87 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D21] Below (N=101,100,97,97,99,99)
|
6 Subjects
|
5 Subjects
|
3 Subjects
|
6 Subjects
|
5 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D28] Below (N=101,98,96,98,98,97)
|
10 Subjects
|
6 Subjects
|
8 Subjects
|
9 Subjects
|
5 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D0] Below (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D0] Within (N=102,104,102,100,101,102)
|
101 Subjects
|
104 Subjects
|
101 Subjects
|
99 Subjects
|
100 Subjects
|
102 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D0] Above (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D7] Below (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D7] Within (N=102,101,100,99,100,99)
|
102 Subjects
|
101 Subjects
|
100 Subjects
|
99 Subjects
|
100 Subjects
|
99 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D7] Unknown(N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D21] Below (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D21] Within (N=101,100,97,97,99,99)
|
101 Subjects
|
100 Subjects
|
97 Subjects
|
97 Subjects
|
99 Subjects
|
98 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D21] Above (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D7] Within (N=102,101,100,99,100,99)
|
94 Subjects
|
93 Subjects
|
91 Subjects
|
81 Subjects
|
93 Subjects
|
90 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D28] Below (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D28] Within (N=101,98,96,98,98,97)
|
100 Subjects
|
98 Subjects
|
96 Subjects
|
97 Subjects
|
98 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D42] Below (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D42] Within (N=101,97,95,95,96,97)
|
101 Subjects
|
97 Subjects
|
94 Subjects
|
95 Subjects
|
94 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D63] Within (N=100,95,95,95,97,97)
|
99 Subjects
|
94 Subjects
|
94 Subjects
|
95 Subjects
|
96 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D21] Within (N=101,100,97,97,99,99)
|
88 Subjects
|
92 Subjects
|
92 Subjects
|
81 Subjects
|
89 Subjects
|
87 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D21] Below (N=101,100,97,97,99,99)
|
12 Subjects
|
6 Subjects
|
5 Subjects
|
16 Subjects
|
10 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D182] Within (N=99,91,88,91,93,97)
|
99 Subjects
|
90 Subjects
|
88 Subjects
|
91 Subjects
|
92 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D182] Above (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
BIL D [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D0] Below (N=102,104,102,100,101,102)
|
8 Subjects
|
6 Subjects
|
6 Subjects
|
9 Subjects
|
8 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D7] Within (N=102,101,100,99,100,99)
|
93 Subjects
|
93 Subjects
|
91 Subjects
|
95 Subjects
|
92 Subjects
|
89 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D0] Within (N=102,104,102,100,101,102)
|
93 Subjects
|
97 Subjects
|
94 Subjects
|
88 Subjects
|
92 Subjects
|
92 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D0] Above (N=102,104,102,100,101,102)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D0] Unknown (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D7] Below (N=102,101,100,99,100,99)
|
8 Subjects
|
6 Subjects
|
9 Subjects
|
17 Subjects
|
7 Subjects
|
8 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D7] Above (N=102,101,100,99,100,99)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D21] Above (N=101,100,97,97,99,99)
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D28] Below (N=101,98,96,98,98,97)
|
5 Subjects
|
8 Subjects
|
6 Subjects
|
15 Subjects
|
7 Subjects
|
7 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D28] Within (N=101,98,96,98,98,97)
|
95 Subjects
|
90 Subjects
|
89 Subjects
|
81 Subjects
|
91 Subjects
|
89 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D63] Within (N=100,95,95,95,97,97)
|
92 Subjects
|
86 Subjects
|
87 Subjects
|
78 Subjects
|
89 Subjects
|
85 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D63] Unknown (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D182] Above (N=99,91,88,91,93,97)
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D182] Below (N=99,91,88,91,93,97)
|
14 Subjects
|
7 Subjects
|
7 Subjects
|
10 Subjects
|
6 Subjects
|
14 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
CREA [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D0] Below (N=102,104,102,100,101,102)
|
2 Subjects
|
6 Subjects
|
7 Subjects
|
5 Subjects
|
9 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D21] Below (N=101,100,97,97,99,99)
|
2 Subjects
|
8 Subjects
|
9 Subjects
|
8 Subjects
|
9 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D0] Above (N=102,104,102,100,101,102)
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D63] Above (N=100,95,95,95,97,97)
|
1 Subjects
|
4 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D182] Below (N=99,91,88,91,93,97)
|
3 Subjects
|
4 Subjects
|
9 Subjects
|
3 Subjects
|
6 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D182] Above (N=99,91,88,91,93,97)
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
3 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D0] Within (N=102,104,102,100,101,102)
|
94 Subjects
|
99 Subjects
|
95 Subjects
|
92 Subjects
|
97 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D0] Above (N=102,104,102,100,101,102)
|
2 Subjects
|
3 Subjects
|
3 Subjects
|
3 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D0] Unknown (N=102,104,102,100,101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D21] Within (N=101,100,97,97,99,99)
|
97 Subjects
|
87 Subjects
|
85 Subjects
|
87 Subjects
|
85 Subjects
|
92 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D7] Within (N=102,101,100,99,100,99)
|
93 Subjects
|
91 Subjects
|
95 Subjects
|
92 Subjects
|
97 Subjects
|
92 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D21] Above (N=101,100,97,97,99,99)
|
2 Subjects
|
4 Subjects
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D7] Above (N=102,101,100,99,100,99)
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D28] Below (N=101,98,96,98,98,97)
|
4 Subjects
|
4 Subjects
|
7 Subjects
|
2 Subjects
|
7 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D42] Below (N=101,97,95,95,96,97)
|
4 Subjects
|
9 Subjects
|
6 Subjects
|
5 Subjects
|
8 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D42] Within (N=101,97,95,95,96,97)
|
96 Subjects
|
86 Subjects
|
89 Subjects
|
89 Subjects
|
85 Subjects
|
88 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D42] Above (N=101,97,95,95,96,97)
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
EOS [D63] Within (N=100,95,95,95,97,97)
|
97 Subjects
|
82 Subjects
|
85 Subjects
|
90 Subjects
|
88 Subjects
|
86 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D21] Within (N=101,100,97,97,99,99)
|
92 Subjects
|
94 Subjects
|
88 Subjects
|
88 Subjects
|
91 Subjects
|
91 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D0] Below (N=102,104,102,100,101,102)
|
2 Subjects
|
6 Subjects
|
5 Subjects
|
1 Subjects
|
4 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D0] Within (N=102,104,102,100,101,102)
|
97 Subjects
|
97 Subjects
|
95 Subjects
|
97 Subjects
|
97 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D0] Above (N=102,104,102,100,101,102)
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D0] Unknown (N=102,104,102,100,101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D7] Below (N=102,101,100,99,100,99)
|
6 Subjects
|
7 Subjects
|
5 Subjects
|
2 Subjects
|
4 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D7] Within (N=102,101,100,99,100,99)
|
94 Subjects
|
91 Subjects
|
94 Subjects
|
96 Subjects
|
96 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D7] Above (N=102,101,100,99,100,99)
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D28] Within (N=101,98,96,98,98,97)
|
89 Subjects
|
88 Subjects
|
86 Subjects
|
88 Subjects
|
92 Subjects
|
84 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D28] Above (N=101,98,96,98,98,97)
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D21] Within (N=101,100,97,97,99,99)
|
93 Subjects
|
94 Subjects
|
90 Subjects
|
90 Subjects
|
92 Subjects
|
91 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D42] Below (N=101,97,95,95,96,97)
|
11 Subjects
|
9 Subjects
|
9 Subjects
|
7 Subjects
|
10 Subjects
|
14 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D21] Above (N=101,100,97,97,99,99)
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D42] Within (N=101,97,95,95,96,97)
|
90 Subjects
|
86 Subjects
|
86 Subjects
|
88 Subjects
|
86 Subjects
|
83 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D28] Below (N=101,98,96,98,98,97)
|
10 Subjects
|
7 Subjects
|
5 Subjects
|
8 Subjects
|
1 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D28] Within (N=101,98,96,98,98,97)
|
90 Subjects
|
88 Subjects
|
89 Subjects
|
89 Subjects
|
96 Subjects
|
90 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D42] Below (N=101,97,95,95,96,97)
|
7 Subjects
|
8 Subjects
|
6 Subjects
|
3 Subjects
|
6 Subjects
|
11 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D42] Within (N=101,97,95,95,96,97)
|
94 Subjects
|
87 Subjects
|
89 Subjects
|
92 Subjects
|
90 Subjects
|
86 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D63] Below (N=100,95,95,95,97,97)
|
8 Subjects
|
10 Subjects
|
11 Subjects
|
6 Subjects
|
10 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D182] Below (N=99,91,88,91,93,97)
|
4 Subjects
|
6 Subjects
|
4 Subjects
|
3 Subjects
|
7 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hct [D182] Within (N=99,91,88,91,93,97)
|
93 Subjects
|
84 Subjects
|
82 Subjects
|
85 Subjects
|
86 Subjects
|
86 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D63] Below (N=100,95,95,95,97,97)
|
8 Subjects
|
10 Subjects
|
6 Subjects
|
4 Subjects
|
9 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D63] Within (N=100,95,95,95,97,97)
|
92 Subjects
|
83 Subjects
|
89 Subjects
|
91 Subjects
|
88 Subjects
|
87 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D182] Below (N=99,91,88,91,93,97)
|
9 Subjects
|
6 Subjects
|
5 Subjects
|
5 Subjects
|
6 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D182] Within (N=99,91,88,91,93,97)
|
89 Subjects
|
84 Subjects
|
81 Subjects
|
84 Subjects
|
87 Subjects
|
87 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D182] Above (N=99,91,88,91,93,97)
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
Hgb [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Days 0-6) post-vaccination periodPopulation: The Total Vaccinated cohort included all vaccinated subjects
Solicited local symptoms assessed were pain, redness and swelling
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=99 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=100 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms.
Pain
|
75 Subjects
|
89 Subjects
|
66 Subjects
|
94 Subjects
|
69 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local Symptoms.
Redness
|
2 Subjects
|
6 Subjects
|
1 Subjects
|
5 Subjects
|
1 Subjects
|
11 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local Symptoms.
Swelling
|
2 Subjects
|
15 Subjects
|
2 Subjects
|
9 Subjects
|
0 Subjects
|
16 Subjects
|
—
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Days 0-6) post-vaccination periodPopulation: The Total Vaccinated cohort included all vaccinated subjects
Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=99 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=100 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms.
Shivering
|
21 Subjects
|
30 Subjects
|
19 Subjects
|
24 Subjects
|
21 Subjects
|
25 Subjects
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms.
Sweating
|
22 Subjects
|
21 Subjects
|
21 Subjects
|
17 Subjects
|
12 Subjects
|
25 Subjects
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms.
Temperature (axillary) >=38°C
|
3 Subjects
|
9 Subjects
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms.
Fatigue
|
54 Subjects
|
62 Subjects
|
41 Subjects
|
58 Subjects
|
57 Subjects
|
56 Subjects
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms.
Headache
|
52 Subjects
|
58 Subjects
|
51 Subjects
|
51 Subjects
|
49 Subjects
|
54 Subjects
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms.
Joint pain at other location
|
24 Subjects
|
34 Subjects
|
24 Subjects
|
28 Subjects
|
26 Subjects
|
23 Subjects
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms.
Muscle aches
|
38 Subjects
|
52 Subjects
|
39 Subjects
|
53 Subjects
|
43 Subjects
|
54 Subjects
|
—
|
SECONDARY outcome
Timeframe: On Days 0, 7, 21, 28, 42, 63 and 182Population: The Total Vaccinated cohort included all vaccinated subjects
Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D182] Above (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D0] Below (N=102,104,102,100101,102)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D0] Below (N=102,104,102,100101,102)
|
4 Subjects
|
2 Subjects
|
7 Subjects
|
3 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D0] Within (N=102,104,102,100101,102)
|
96 Subjects
|
100 Subjects
|
95 Subjects
|
93 Subjects
|
99 Subjects
|
98 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D63] Below (N=100,95,95,95,97,97)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D63] Within (N=100,95,95,95,97,97)
|
98 Subjects
|
94 Subjects
|
93 Subjects
|
93 Subjects
|
96 Subjects
|
94 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D63] Unknown (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D182] Below (N=99,91,88,91,93,97)
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D182] Within (N=99,91,88,91,93,97)
|
99 Subjects
|
88 Subjects
|
87 Subjects
|
90 Subjects
|
91 Subjects
|
94 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D0] Below (N=102,104,102,100,101,102)
|
1 Subjects
|
2 Subjects
|
5 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D0] Within (N=102,104,102,100,101,102)
|
95 Subjects
|
100 Subjects
|
94 Subjects
|
93 Subjects
|
95 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D0] Above (N=102,104,102,100,101,102)
|
4 Subjects
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
4 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D0] Unknown (N=102,104,102,100,101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D7] Below (N=102,101,100,99,100,99)
|
3 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D7] Within (N=102,101,100,99,100,99)
|
99 Subjects
|
97 Subjects
|
98 Subjects
|
92 Subjects
|
94 Subjects
|
94 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D7] Above (N=102,101,100,99,100,99)
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
5 Subjects
|
3 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D21] Below (N=101,100,97,97,99,99)
|
1 Subjects
|
4 Subjects
|
2 Subjects
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D21] Within (N=101,100,97,97,99,99)
|
98 Subjects
|
94 Subjects
|
90 Subjects
|
93 Subjects
|
91 Subjects
|
90 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D21] Above (N=101,100,97,97,99,99)
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D0] Above (N=102,104,102,100101,102)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D28] Below (N=101,98,96,98,98,97)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D28] Within (N=101,98,96,98,98,97)
|
98 Subjects
|
92 Subjects
|
92 Subjects
|
92 Subjects
|
93 Subjects
|
91 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D28] Above (N=101,98,96,98,98,97)
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D28] Unknown (N=101,98,96,98,98,97)
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D182] Above (N=99,91,88,91,93,97)
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D42] Below (N=101,97,95,95,96,97)
|
0 Subjects
|
4 Subjects
|
2 Subjects
|
3 Subjects
|
3 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D21] Within (N=101,100,97,97,99,99)
|
96 Subjects
|
92 Subjects
|
89 Subjects
|
90 Subjects
|
94 Subjects
|
90 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D42] Within (N=101,97,95,95,96,97)
|
100 Subjects
|
91 Subjects
|
92 Subjects
|
90 Subjects
|
92 Subjects
|
91 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D42] Above (N=101,97,95,95,96,97)
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D63] Below (N=100,95,95,95,97,97)
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D63] Within (N=100,95,95,95,97,97)
|
98 Subjects
|
92 Subjects
|
93 Subjects
|
89 Subjects
|
91 Subjects
|
91 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D63] Above (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
4 Subjects
|
3 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D182] Below (N=99,91,88,91,93,97)
|
2 Subjects
|
2 Subjects
|
4 Subjects
|
3 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D182] Within (N=99,91,88,91,93,97)
|
93 Subjects
|
87 Subjects
|
82 Subjects
|
84 Subjects
|
88 Subjects
|
91 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D182] Above (N=99,91,88,91,93,97)
|
4 Subjects
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
3 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
WBC [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D7] Below (N=102,101,100,99,100,99)
|
2 Subjects
|
1 Subjects
|
4 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D0] Unknown (N=102,104,102,100101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D7] Below (N=102,101,100,99,100,99)
|
3 Subjects
|
5 Subjects
|
5 Subjects
|
4 Subjects
|
5 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D7] Within (N=102,101,100,99,100,99)
|
99 Subjects
|
94 Subjects
|
95 Subjects
|
93 Subjects
|
95 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D7] Above (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D21] Below (N=101,100,97,97,99,99)
|
5 Subjects
|
7 Subjects
|
5 Subjects
|
6 Subjects
|
3 Subjects
|
6 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D21] Above (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D28] Below (N=101,98,96,98,98,97)
|
5 Subjects
|
8 Subjects
|
8 Subjects
|
7 Subjects
|
2 Subjects
|
8 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D28] Within (N=101,98,96,98,98,97)
|
95 Subjects
|
87 Subjects
|
88 Subjects
|
89 Subjects
|
95 Subjects
|
86 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D42] Below (N=101,97,95,95,96,97)
|
2 Subjects
|
9 Subjects
|
9 Subjects
|
6 Subjects
|
7 Subjects
|
12 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D42] Within (N=101,97,95,95,96,97)
|
99 Subjects
|
87 Subjects
|
86 Subjects
|
89 Subjects
|
89 Subjects
|
85 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D0] Within (N=102,104,102,100101,102)
|
100 Subjects
|
104 Subjects
|
100 Subjects
|
98 Subjects
|
98 Subjects
|
99 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D63] Below (N=100,95,95,95,97,97)
|
6 Subjects
|
8 Subjects
|
5 Subjects
|
5 Subjects
|
6 Subjects
|
12 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D0] Above (N=102,104,102,100101,102)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D63] Within (N=100,95,95,95,97,97)
|
94 Subjects
|
86 Subjects
|
90 Subjects
|
89 Subjects
|
91 Subjects
|
85 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D0] Unknown (N=102,104,102,100101,102)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D7] Within (N=102,101,100,99,100,99)
|
100 Subjects
|
99 Subjects
|
96 Subjects
|
98 Subjects
|
99 Subjects
|
99 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D7] Above (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D21] Below (N=101,100,97,97,99,99)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D21] Within (N=101,100,97,97,99,99)
|
100 Subjects
|
99 Subjects
|
96 Subjects
|
95 Subjects
|
98 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D21] Above (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D28] Below (N=101,98,96,98,98,97)
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D28] Within (N=101,98,96,98,98,97)
|
98 Subjects
|
97 Subjects
|
96 Subjects
|
97 Subjects
|
98 Subjects
|
91 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D42] Below (N=101,97,95,95,96,97)
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
SUN [D42] Within (N=101,97,95,95,96,97)
|
100 Subjects
|
96 Subjects
|
91 Subjects
|
94 Subjects
|
92 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D182] Below (N=99,91,88,91,93,97)
|
6 Subjects
|
6 Subjects
|
9 Subjects
|
4 Subjects
|
5 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
RBC [D182] Within (N=99,91,88,91,93,97)
|
92 Subjects
|
85 Subjects
|
77 Subjects
|
84 Subjects
|
88 Subjects
|
87 Subjects
|
—
|
SECONDARY outcome
Timeframe: Within the 84-day (Days 0-83) post-vaccination period.Population: The Total Vaccinated Cohort included all vaccinated subjects.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
|
68 Subjects
|
65 Subjects
|
57 Subjects
|
57 Subjects
|
62 Subjects
|
63 Subjects
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0-368).Population: The Total Vaccinated Cohort included all vaccinated subjects.
The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Medically Attended Visits (MAEs).
|
51 Subjects
|
42 Subjects
|
40 Subjects
|
42 Subjects
|
38 Subjects
|
45 Subjects
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0-406).Population: The Total Vaccinated Cohort included all vaccinated subjects.
The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Potential Immune Diseases (pIMDs).
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0-329).Population: The Total Vaccinated Cohort included all vaccinated subjects.
The day 329 was the last contact day with the subjects reporting serious adverse events. SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs).
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
SECONDARY outcome
Timeframe: On Days 0, 7, 21, 28, 42, 63 and 182Population: The Total Vaccinated cohort included all vaccinated subjects
Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D0] Above (N=102,104,102,100,101,102)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D63] Below (N=100,95,95,95,97,97)
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D182] Above (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D21] Below (N=101,100,97,97,99,99)
|
25 Subjects
|
20 Subjects
|
20 Subjects
|
12 Subjects
|
18 Subjects
|
20 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D21] Within (N=101,100,97,97,99,99)
|
76 Subjects
|
79 Subjects
|
74 Subjects
|
84 Subjects
|
79 Subjects
|
75 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D21] Above (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D7] Within (N=102,101,100,99,100,99)
|
101 Subjects
|
100 Subjects
|
100 Subjects
|
97 Subjects
|
99 Subjects
|
99 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D0] Below (N=102,104,102,100,101,102)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D0] Within (N=102,104,102,100,101,102)
|
100 Subjects
|
101 Subjects
|
102 Subjects
|
98 Subjects
|
101 Subjects
|
101 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D0] Unknown (N=102,104,102,100,101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D7] Below (N=102,101,100,99,100,99)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D7] Within (N=102,101,100,99,100,99)
|
100 Subjects
|
100 Subjects
|
99 Subjects
|
98 Subjects
|
100 Subjects
|
98 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D7] Above (N=102,101,100,99,100,99)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D21] Below (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D21] Within (N=101,100,97,97,99,99)
|
101 Subjects
|
98 Subjects
|
94 Subjects
|
95 Subjects
|
97 Subjects
|
94 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D21] Above (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D28] Below (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D28] Within (N=101,98,96,98,98,97)
|
99 Subjects
|
96 Subjects
|
95 Subjects
|
96 Subjects
|
97 Subjects
|
93 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D28] Unknown (N=101,98,96,98,98,97)
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D42] Below (N=101,97,95,95,96,97)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D42] Within (N=101,97,95,95,96,97)
|
101 Subjects
|
95 Subjects
|
95 Subjects
|
94 Subjects
|
93 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D63] Below (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D63] Within (N=100,95,95,95,97,97)
|
100 Subjects
|
95 Subjects
|
95 Subjects
|
95 Subjects
|
96 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D182] Below (N=99,91,88,91,93,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D182] Within (N=99,91,88,91,93,97)
|
98 Subjects
|
90 Subjects
|
88 Subjects
|
89 Subjects
|
91 Subjects
|
95 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D182] Above (N=99,91,88,91,93,97)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
LYM [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D0] Below (N=102,104,102,100,101,102)
|
11 Subjects
|
18 Subjects
|
26 Subjects
|
18 Subjects
|
13 Subjects
|
23 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D0] Within (N=102,104,102,100,101,102)
|
89 Subjects
|
86 Subjects
|
75 Subjects
|
79 Subjects
|
88 Subjects
|
79 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D0] Above (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D0] Unknown (N=102,104,102,100,101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D7] Below (N=102,101,100,99,100,99)
|
20 Subjects
|
14 Subjects
|
22 Subjects
|
12 Subjects
|
13 Subjects
|
22 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D7] Within (N=102,101,100,99,100,99)
|
82 Subjects
|
86 Subjects
|
78 Subjects
|
86 Subjects
|
87 Subjects
|
77 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D7] Above (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D28] Below (N=101,98,96,98,98,97)
|
17 Subjects
|
19 Subjects
|
26 Subjects
|
26 Subjects
|
17 Subjects
|
19 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D28] Within (N=101,98,96,98,98,97)
|
82 Subjects
|
77 Subjects
|
70 Subjects
|
70 Subjects
|
80 Subjects
|
75 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D28] Unknown (N=101,98,96,98,98,97)
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D42] Below (N=101,97,95,95,96,97)
|
16 Subjects
|
19 Subjects
|
20 Subjects
|
25 Subjects
|
20 Subjects
|
20 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D42] Within (N=101,97,95,95,96,97)
|
85 Subjects
|
78 Subjects
|
75 Subjects
|
70 Subjects
|
76 Subjects
|
77 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D42] Unknown (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D63] Below (N=100,95,95,95,97,97)
|
17 Subjects
|
20 Subjects
|
21 Subjects
|
19 Subjects
|
15 Subjects
|
18 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D63] Within (N=100,95,95,95,97,97)
|
82 Subjects
|
75 Subjects
|
73 Subjects
|
76 Subjects
|
82 Subjects
|
79 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D63] Above (N=100,95,95,95,97,97)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D182] Below (N=99,91,88,91,93,97)
|
17 Subjects
|
20 Subjects
|
20 Subjects
|
21 Subjects
|
20 Subjects
|
23 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D182] Within (N=99,91,88,91,93,97)
|
82 Subjects
|
71 Subjects
|
68 Subjects
|
68 Subjects
|
73 Subjects
|
73 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D182] Above (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
MON [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D0] Below (N=102,104,102,100,101,102)
|
1 Subjects
|
4 Subjects
|
4 Subjects
|
4 Subjects
|
0 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D0] Within (N=102,104,102,100,101,102)
|
98 Subjects
|
98 Subjects
|
97 Subjects
|
92 Subjects
|
98 Subjects
|
93 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D0] Above (N=102,104,102,100,101,102)
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D0] Unknown (N=102,104,102,100,101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D7] Below (N=101,100,98,97,97,97)
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D7] Within (N=101,100,98,97,97,97)
|
96 Subjects
|
94 Subjects
|
94 Subjects
|
90 Subjects
|
93 Subjects
|
91 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D7] Above (N=101,100,98,97,97,97)
|
3 Subjects
|
3 Subjects
|
2 Subjects
|
4 Subjects
|
3 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D7] Unknown (N=101,100,98,97,97,97)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D21] Below (N=101,100,97,97,99,99)
|
3 Subjects
|
5 Subjects
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D21] Within (N=101,100,97,97,99,99)
|
97 Subjects
|
92 Subjects
|
91 Subjects
|
93 Subjects
|
92 Subjects
|
88 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D21] Above (N=101,100,97,97,99,99)
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D28] Below (N=101,98,96,98,98,97)
|
1 Subjects
|
5 Subjects
|
3 Subjects
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D28] Within (N=101,98,96,98,98,97)
|
98 Subjects
|
89 Subjects
|
92 Subjects
|
93 Subjects
|
93 Subjects
|
91 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D28] Unknown (N=101,98,96,98,98,97)
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D42] Below (N=101,97,95,95,96,97)
|
3 Subjects
|
4 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D42] Within (N=101,97,95,95,96,97)
|
98 Subjects
|
91 Subjects
|
94 Subjects
|
92 Subjects
|
93 Subjects
|
93 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D63] Below (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D63] Within (N=100,95,95,95,97,97)
|
98 Subjects
|
93 Subjects
|
94 Subjects
|
92 Subjects
|
92 Subjects
|
88 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D63] Above (N=100,95,95,95,97,97)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
2 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D63] Unknown (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D182] Below (N=99,91,88,91,93,97)
|
3 Subjects
|
3 Subjects
|
4 Subjects
|
2 Subjects
|
1 Subjects
|
6 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D182] Within (N=99,91,88,91,93,97)
|
93 Subjects
|
86 Subjects
|
83 Subjects
|
86 Subjects
|
89 Subjects
|
89 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D182] Above (N=99,91,88,91,93,97)
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
NEU [D182] Unknown (N=99,91,88,91,93,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D0] Below (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D0] Within (N=102,104,102,100,101,102)
|
100 Subjects
|
104 Subjects
|
102 Subjects
|
97 Subjects
|
98 Subjects
|
101 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D0] Above (N=102,104,102,100,101,102)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D0] Unknown (N=102,104,102,100,101,102)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D7] Below (N=102,101,100,99,100,99)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D7] Above (N=102,101,100,99,100,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D7] Unknown (N=102,101,100,99,100,99)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D21] Below (N=101,100,97,97,99,99)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D21] Within (N=101,100,97,97,99,99)
|
100 Subjects
|
99 Subjects
|
93 Subjects
|
96 Subjects
|
97 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D21] Above (N=101,100,97,97,99,99)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D21] Unknown (N=101,100,97,97,99,99)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D28] Below (N=101,98,96,98,98,97)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D28] Within (N=101,98,96,98,98,97)
|
98 Subjects
|
96 Subjects
|
96 Subjects
|
96 Subjects
|
95 Subjects
|
94 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D28] Above (N=101,98,96,98,98,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D28] Unknown (N=101,98,96,98,98,97)
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D42] Below (N=101,97,95,95,96,97)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D42] Within (N=101,97,95,95,96,97)
|
100 Subjects
|
96 Subjects
|
93 Subjects
|
95 Subjects
|
93 Subjects
|
97 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D42] Above (N=101,97,95,95,96,97)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D63] Within (N=100,95,95,95,97,97)
|
100 Subjects
|
94 Subjects
|
94 Subjects
|
93 Subjects
|
96 Subjects
|
96 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D63] Above (N=100,95,95,95,97,97)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D182] Below (N=99,91,88,91,93,97)
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed
PLA [D182] Within (N=99,91,88,91,93,97)
|
97 Subjects
|
90 Subjects
|
87 Subjects
|
87 Subjects
|
91 Subjects
|
95 Subjects
|
—
|
SECONDARY outcome
Timeframe: On Days 0, 21, 42, 63 and 182Population: Microneutralization testing was cancelled.
Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization. Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1). Microneutralization testing was cancelled.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Days 0, 21, 42, 63 and 182Population: Microneutralization testing was cancelled.
Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1). The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity. Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers \< 1:28 were considered below the cut-off. Microneutralization testing was cancelled.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Days 0, 21, 42, 63 and 182Population: Microneutralization testing was cancelled.
Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1). Vaccine Response Rate for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. Microneutralization testing was cancelled.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group)Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
|
—
|
645.2 Titers
Interval 557.6 to 746.6
|
—
|
—
|
—
|
933.1 Titers
Interval 815.6 to 1067.6
|
—
|
SECONDARY outcome
Timeframe: 21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group)Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
|
254.2 Titers
Interval 210.1 to 307.7
|
—
|
—
|
—
|
387.1 Titers
Interval 314.4 to 476.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days after the second dose of the pandemic vaccine (at Day 63)Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.
|
254.2 Titers
Interval 210.1 to 307.7
|
645.2 Titers
Interval 557.6 to 746.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days after the Flulaval vaccination (at Day 21).Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu A/BRI/59/07 H1N1
|
145.1 Titers
Interval 115.9 to 181.6
|
215.7 Titers
Interval 168.2 to 276.5
|
—
|
158.7 Titers
Interval 127.9 to 197.1
|
—
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu A/Uru/716/07 H3N2
|
175.7 Titers
Interval 129.6 to 238.2
|
183.5 Titers
Interval 135.2 to 248.9
|
—
|
191.4 Titers
Interval 138.4 to 264.7
|
—
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu B/Bri/60/08
|
662.1 Titers
Interval 545.4 to 803.8
|
658.3 Titers
Interval 540.2 to 802.0
|
—
|
576.1 Titers
Interval 479.8 to 691.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days after the Flulaval vaccination (at Day 21).Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu A/Brisbane/59/07 H1N1
|
145.1 Titers
Interval 115.9 to 181.6
|
215.7 Titers
Interval 168.2 to 276.5
|
226.3 Titers
Interval 181.4 to 282.2
|
—
|
—
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu A/Uru/716/07 H3N2
|
175.7 Titers
Interval 129.6 to 238.2
|
183.5 Titers
Interval 135.2 to 248.9
|
181.7 Titers
Interval 128.1 to 257.9
|
—
|
—
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu B/Brisbane/60/08
|
662.1 Titers
Interval 545.4 to 803.8
|
658.3 Titers
Interval 540.2 to 802.0
|
478.8 Titers
Interval 389.5 to 588.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu A/Uru/716/07 H3N2
|
175.7 Titers
Interval 129.6 to 238.2
|
183.5 Titers
Interval 135.2 to 248.9
|
—
|
—
|
—
|
221.9 Titers
Interval 167.2 to 294.6
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu B/Bri/60/08
|
662.1 Titers
Interval 545.4 to 803.8
|
658.3 Titers
Interval 540.2 to 802.0
|
—
|
—
|
—
|
688.1 Titers
Interval 593.0 to 798.6
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu A/BRI/59/07 H1N1
|
145.1 Titers
Interval 115.9 to 181.6
|
215.7 Titers
Interval 168.2 to 276.5
|
—
|
—
|
—
|
166.9 Titers
Interval 132.5 to 210.3
|
—
|
SECONDARY outcome
Timeframe: 21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine. Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu A/Bri/59/07 H1N1
|
145.1 Titers
Interval 115.9 to 181.6
|
215.7 Titers
Interval 168.2 to 276.5
|
—
|
—
|
137.4 Titers
Interval 109.0 to 173.1
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu A/Uru/716/07 H3N2
|
175.7 Titers
Interval 129.6 to 238.2
|
183.5 Titers
Interval 135.2 to 248.9
|
—
|
—
|
216.1 Titers
Interval 160.0 to 292.0
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.
Flu B/Bri/60/08
|
662.1 Titers
Interval 545.4 to 803.8
|
658.3 Titers
Interval 540.2 to 802.0
|
—
|
—
|
644.9 Titers
Interval 534.5 to 778.2
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 0, 21, 42 and 63Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.
Flu A/Cal H1N1 [at Day 0] (N=92;86;92;88;91;91)
|
14.6 Titers
Interval 11.2 to 19.0
|
10.9 Titers
Interval 8.7 to 13.6
|
13.0 Titers
Interval 10.2 to 16.5
|
10.7 Titers
Interval 8.2 to 14.0
|
9.3 Titers
Interval 7.7 to 11.4
|
10.1 Titers
Interval 8.2 to 12.5
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.
Flu A/Cal H1N1 [at Day 21] (N=92;86;92;89;91;91)
|
31.1 Titers
Interval 24.0 to 40.3
|
26.3 Titers
Interval 19.9 to 34.8
|
277.3 Titers
Interval 222.4 to 345.7
|
361.0 Titers
Interval 301.5 to 432.2
|
358.7 Titers
Interval 285.0 to 451.4
|
659.8 Titers
Interval 546.0 to 797.4
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.
Flu A/Cal H1N1 [at Day 42] (N=92;86;92;89;91;91)
|
238.6 Titers
Interval 191.8 to 296.7
|
396.2 Titers
Interval 329.2 to 476.8
|
271.2 Titers
Interval 224.6 to 327.4
|
589.8 Titers
Interval 517.8 to 671.8
|
387.1 Titers
Interval 314.4 to 476.7
|
933.1 Titers
Interval 815.6 to 1067.6
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.
Flu A/Cal H1N1 [at Day 63] (N=92;86;92;89;91;91)
|
254.2 Titers
Interval 210.1 to 307.7
|
645.2 Titers
Interval 557.6 to 746.6
|
245.0 Titers
Interval 200.7 to 299.1
|
426.9 Titers
Interval 373.0 to 488.5
|
345.3 Titers
Interval 278.6 to 428.0
|
704.0 Titers
Interval 602.1 to 823.1
|
—
|
SECONDARY outcome
Timeframe: At Day 182Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=85 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=89 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.
|
136.6 Titers
Interval 108.6 to 171.9
|
206.9 Titers
Interval 171.3 to 249.9
|
151.7 Titers
Interval 119.1 to 193.2
|
171.7 Titers
Interval 143.2 to 205.8
|
218.5 Titers
Interval 169.8 to 281.1
|
323.6 Titers
Interval 268.8 to 389.5
|
—
|
SECONDARY outcome
Timeframe: At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groupsPopulation: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as \< 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer. Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=88 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Antibodies Against A/ California Strain.
|
66 Subjects
|
77 Subjects
|
84 Subjects
|
85 Subjects
|
88 Subjects
|
90 Subjects
|
—
|
SECONDARY outcome
Timeframe: At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups.Population: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for Antibodies Against A/California Strain.
|
90 Subjects
|
86 Subjects
|
92 Subjects
|
89 Subjects
|
91 Subjects
|
91 Subjects
|
—
|
SECONDARY outcome
Timeframe: At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groupsPopulation: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=88 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for Antibodies Against A/California Strain.
|
8.2 Fold
Interval 6.4 to 10.5
|
24.6 Fold
Interval 18.1 to 33.3
|
20.9 Fold
Interval 16.3 to 26.7
|
54.9 Fold
Interval 42.1 to 71.7
|
41.5 Fold
Interval 32.4 to 53.2
|
92.4 Fold
Interval 73.3 to 116.3
|
—
|
SECONDARY outcome
Timeframe: At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval GroupPopulation: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008. For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=88 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
n=178 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1
|
—
|
—
|
76 Subjects
|
70 Subjects
|
50 Subjects
|
33 Subjects
|
145 Subjects
|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2
|
—
|
—
|
72 Subjects
|
76 Subjects
|
73 Subjects
|
72 Subjects
|
145 Subjects
|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08
|
—
|
—
|
74 Subjects
|
78 Subjects
|
71 Subjects
|
57 Subjects
|
152 Subjects
|
SECONDARY outcome
Timeframe: At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval GroupPopulation: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008. For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
n=178 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains
Flu A/Bri/59/07 H1N1
|
—
|
—
|
89 Subjects
|
82 Subjects
|
81 Subjects
|
87 Subjects
|
170 Subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains
Flu A/Uru/716/07 H3N2
|
—
|
—
|
77 Subjects
|
79 Subjects
|
81 Subjects
|
83 Subjects
|
155 Subjects
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains
Flu B/Bri/60/08
|
—
|
—
|
90 Subjects
|
89 Subjects
|
91 Subjects
|
91 Subjects
|
176 Subjects
|
SECONDARY outcome
Timeframe: At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval GroupPopulation: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008. For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=88 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
n=178 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1
|
—
|
—
|
12.0 Fold
Interval 9.4 to 15.4
|
9.6 Fold
Interval 7.7 to 12.1
|
4.2 Fold
Interval 3.5 to 5.0
|
3.1 Fold
Interval 2.5 to 3.9
|
10.3 Fold
Interval 8.6 to 12.3
|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2
|
—
|
—
|
20.6 Fold
Interval 14.8 to 28.6
|
19.3 Fold
Interval 14.2 to 26.4
|
17.3 Fold
Interval 12.8 to 23.2
|
11.6 Fold
Interval 8.9 to 15.2
|
16.5 Fold
Interval 13.5 to 20.1
|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08
|
—
|
—
|
10.5 Fold
Interval 8.3 to 13.5
|
14.3 Fold
Interval 11.0 to 18.7
|
8.6 Fold
Interval 7.0 to 10.7
|
4.9 Fold
Interval 4.1 to 6.0
|
13.2 Fold
Interval 11.1 to 15.7
|
SECONDARY outcome
Timeframe: on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval GroupsPopulation: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=88 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Flu B/Bri/60/08 [Day 21 or 42 after dose 1]
|
76 Subjects
|
76 Subjects
|
74 Subjects
|
78 Subjects
|
6 Subjects
|
24 Subjects
|
—
|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Flu A/Bri/59/07 H1N1 [Day 21 or 42 after dose 1]
|
71 Subjects
|
74 Subjects
|
76 Subjects
|
70 Subjects
|
17 Subjects
|
28 Subjects
|
—
|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Flu A/Bri/59/07 H1N1 [Day 63 after dose 1]
|
63 Subjects
|
76 Subjects
|
69 Subjects
|
64 Subjects
|
71 Subjects
|
76 Subjects
|
—
|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Flu A/Uru/716/07 H3N2 [Day 21 or 42 after dose 1]
|
72 Subjects
|
73 Subjects
|
72 Subjects
|
76 Subjects
|
3 Subjects
|
6 Subjects
|
—
|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Flu A/Uru/716/07 H3N2 [Day 63 after dose 1]
|
71 Subjects
|
69 Subjects
|
69 Subjects
|
69 Subjects
|
75 Subjects
|
78 Subjects
|
—
|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Flu B/Bri/60/08 [Day 63 after dose 1]
|
73 Subjects
|
73 Subjects
|
67 Subjects
|
73 Subjects
|
78 Subjects
|
76 Subjects
|
—
|
SECONDARY outcome
Timeframe: At Day 182 from Day 0Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=85 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=88 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=89 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Flu A/Bri/59/07 H1N1
|
45 Subjects
|
57 Subjects
|
45 Subjects
|
38 Subjects
|
46 Subjects
|
54 Subjects
|
—
|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Flu A/Uru/716/07 H3N2
|
58 Subjects
|
56 Subjects
|
54 Subjects
|
56 Subjects
|
60 Subjects
|
61 Subjects
|
—
|
|
Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains
Flu B/Bri/60/08 Victoria
|
68 Subjects
|
54 Subjects
|
48 Subjects
|
64 Subjects
|
67 Subjects
|
62 Subjects
|
—
|
SECONDARY outcome
Timeframe: before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval GroupsPopulation: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1 [at Day 0]
|
20 Subjects
|
18 Subjects
|
26 Subjects
|
18 Subjects
|
23 Subjects
|
20 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1 [Days 21 or 42 post dose 1]
|
86 Subjects
|
84 Subjects
|
89 Subjects
|
82 Subjects
|
47 Subjects
|
62 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1]
|
84 Subjects
|
86 Subjects
|
85 Subjects
|
79 Subjects
|
81 Subjects
|
87 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2 [at Day 0]
|
12 Subjects
|
16 Subjects
|
8 Subjects
|
13 Subjects
|
15 Subjects
|
17 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2 [Days 21 or 42 post dose 1]
|
78 Subjects
|
77 Subjects
|
77 Subjects
|
79 Subjects
|
18 Subjects
|
28 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1]
|
78 Subjects
|
75 Subjects
|
73 Subjects
|
75 Subjects
|
81 Subjects
|
83 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 [at Day 0]
|
62 Subjects
|
50 Subjects
|
56 Subjects
|
49 Subjects
|
66 Subjects
|
62 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 [Days 21 or 42 post dose 1]
|
91 Subjects
|
85 Subjects
|
90 Subjects
|
89 Subjects
|
75 Subjects
|
89 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 [at Day 63 post dose 1]
|
91 Subjects
|
86 Subjects
|
91 Subjects
|
89 Subjects
|
91 Subjects
|
91 Subjects
|
—
|
SECONDARY outcome
Timeframe: At Day 182 after the first dosePopulation: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=85 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=89 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 Victoria
|
90 Subjects
|
88 Subjects
|
79 Subjects
|
89 Subjects
|
88 Subjects
|
91 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2
|
66 Subjects
|
64 Subjects
|
60 Subjects
|
64 Subjects
|
68 Subjects
|
70 Subjects
|
—
|
|
Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1
|
63 Subjects
|
74 Subjects
|
66 Subjects
|
61 Subjects
|
67 Subjects
|
71 Subjects
|
—
|
SECONDARY outcome
Timeframe: On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval GroupsPopulation: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=88 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1 [Day 21 or 42 post dose 1]
|
8.4 Fold
Interval 6.5 to 10.8
|
12.9 Fold
Interval 10.0 to 16.6
|
12.0 Fold
Interval 9.4 to 15.4
|
9.6 Fold
Interval 7.7 to 12.1
|
2.3 Fold
Interval 1.9 to 2.6
|
3.2 Fold
Interval 2.7 to 3.8
|
—
|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1 [at Day 63 post dose 1]
|
6.9 Fold
Interval 5.4 to 8.9
|
11.2 Fold
Interval 9.1 to 13.7
|
8.4 Fold
Interval 6.6 to 10.6
|
7.6 Fold
Interval 6.0 to 9.5
|
9.4 Fold
Interval 7.6 to 11.7
|
10.1 Fold
Interval 8.1 to 12.6
|
—
|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2 [Day 21 or 42 post dose 1]
|
17.4 Fold
Interval 13.0 to 23.3
|
15.5 Fold
Interval 11.8 to 20.4
|
20.6 Fold
Interval 14.8 to 28.6
|
19.3 Fold
Interval 14.2 to 26.4
|
1.2 Fold
Interval 1.1 to 1.4
|
1.7 Fold
Interval 1.5 to 1.9
|
—
|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2 [at Day 63 post dose 1]
|
13.3 Fold
Interval 10.0 to 17.6
|
11.7 Fold
Interval 9.1 to 15.0
|
15.0 Fold
Interval 11.2 to 19.9
|
14.6 Fold
Interval 10.9 to 19.6
|
20.8 Fold
Interval 15.5 to 28.0
|
19.3 Fold
Interval 14.6 to 25.5
|
—
|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu B:Bri/60/08 [Day 21 or 42 post dose 1]
|
12.6 Fold
Interval 9.8 to 16.2
|
13.9 Fold
Interval 11.1 to 17.5
|
10.5 Fold
Interval 8.3 to 13.5
|
14.3 Fold
Interval 11.0 to 18.7
|
1.3 Fold
Interval 1.1 to 1.5
|
2.4 Fold
Interval 2.0 to 2.8
|
—
|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 [at Day 63 post dose 1]
|
9.6 Fold
Interval 7.5 to 12.4
|
10.0 Fold
Interval 8.1 to 12.2
|
7.9 Fold
Interval 6.3 to 9.9
|
10.8 Fold
Interval 8.4 to 13.7
|
11.4 Fold
Interval 9.1 to 14.2
|
11.9 Fold
Interval 9.4 to 15.0
|
—
|
SECONDARY outcome
Timeframe: At Day 182 from Day 0Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=85 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=88 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=89 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1
|
4.0 Fold
Interval 3.1 to 5.3
|
5.2 Fold
Interval 4.2 to 6.6
|
4.7 Fold
Interval 3.7 to 6.0
|
3.7 Fold
Interval 2.9 to 4.8
|
4.4 Fold
Interval 3.5 to 5.4
|
5.0 Fold
Interval 4.0 to 6.3
|
—
|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2
|
9.0 Fold
Interval 6.7 to 11.9
|
7.2 Fold
Interval 5.6 to 9.3
|
9.7 Fold
Interval 7.2 to 13.1
|
8.5 Fold
Interval 6.2 to 11.7
|
9.9 Fold
Interval 7.3 to 13.5
|
10.6 Fold
Interval 7.9 to 14.2
|
—
|
|
Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 Victoria
|
6.7 Fold
Interval 5.2 to 8.6
|
5.7 Fold
Interval 4.5 to 7.1
|
5.5 Fold
Interval 4.3 to 6.9
|
6.8 Fold
Interval 5.3 to 8.6
|
6.9 Fold
Interval 5.4 to 8.7
|
6.4 Fold
Interval 5.0 to 8.1
|
—
|
SECONDARY outcome
Timeframe: On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval GroupsPopulation: The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.
Titers were expressed as geometric mean titers (GMTs). Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=86 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1 [at Day 0]
|
17.3 Titers
Interval 14.1 to 21.3
|
16.7 Titers
Interval 13.8 to 20.2
|
18.8 Titers
Interval 15.2 to 23.3
|
16.2 Titers
Interval 12.8 to 20.6
|
14.6 Titers
Interval 12.0 to 17.8
|
16.6 Titers
Interval 13.7 to 20.0
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1 [at Day 21 or 42]
|
145.1 Titers
Interval 115.9 to 181.6
|
215.7 Titers
Interval 168.2 to 276.5
|
226.3 Titers
Interval 181.4 to 282.2
|
158.7 Titers
Interval 127.9 to 197.1
|
32.9 Titers
Interval 27.3 to 39.7
|
53.2 Titers
Interval 43.5 to 65.1
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1 [at Day 63]
|
120.2 Titers
Interval 96.5 to 149.7
|
186.5 Titers
Interval 150.4 to 231.4
|
157.0 Titers
Interval 126.0 to 195.8
|
124.3 Titers
Interval 99.0 to 156.1
|
137.4 Titers
Interval 109.0 to 173.1
|
166.9 Titers
Interval 132.5 to 210.3
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2 [at Day 0]
|
10.1 Titers
Interval 8.1 to 12.5
|
11.8 Titers
Interval 9.7 to 14.4
|
8.8 Titers
Interval 7.4 to 10.6
|
10.2 Titers
Interval 8.3 to 12.6
|
10.4 Titers
Interval 8.4 to 12.8
|
11.5 Titers
Interval 9.4 to 14.1
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2 [at Day 21 or 42]
|
175.7 Titers
Interval 129.6 to 238.2
|
183.5 Titers
Interval 135.2 to 248.9
|
181.7 Titers
Interval 128.1 to 257.9
|
191.4 Titers
Interval 138.4 to 264.7
|
12.5 Titers
Interval 10.0 to 15.6
|
19.1 Titers
Interval 15.6 to 23.4
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2 [at Day 63]
|
134.4 Titers
Interval 100.4 to 179.9
|
138.4 Titers
Interval 104.8 to 182.7
|
132.0 Titers
Interval 94.9 to 183.7
|
145.6 Titers
Interval 107.7 to 196.8
|
216.1 Titers
Interval 160.0 to 292.0
|
221.9 Titers
Interval 167.2 to 294.6
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 [at Day 0]
|
52.6 Titers
Interval 41.8 to 66.3
|
47.3 Titers
Interval 38.0 to 58.9
|
45.4 Titers
Interval 36.0 to 57.4
|
40.1 Titers
Interval 31.5 to 51.1
|
56.7 Titers
Interval 45.7 to 70.5
|
58.0 Titers
Interval 47.2 to 71.4
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 [at Day 21 or 42]
|
662.1 Titers
Interval 545.4 to 803.8
|
658.3 Titers
Interval 540.2 to 802.0
|
478.8 Titers
Interval 389.5 to 588.6
|
576.1 Titers
Interval 479.8 to 691.8
|
74.7 Titers
Interval 61.4 to 90.9
|
139.5 Titers
Interval 120.0 to 162.2
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 [at Day 63]
|
506.7 Titers
Interval 422.3 to 608.0
|
471.2 Titers
Interval 396.3 to 560.2
|
359.6 Titers
Interval 299.4 to 431.9
|
433.5 Titers
Interval 369.5 to 508.7
|
644.9 Titers
Interval 534.5 to 778.2
|
688.1 Titers
Interval 593.0 to 798.6
|
—
|
SECONDARY outcome
Timeframe: At Day 182 after dose 1 vaccinationPopulation: The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.
Titers were expressed as geometric mean titers (GMTs). Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.
Outcome measures
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=92 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=85 Participants
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=89 Participants
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=89 Participants
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=91 Participants
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu A/Bri/59/07 H1N1
|
68.5 Titers
Interval 53.6 to 87.4
|
89.2 Titers
Interval 71.0 to 112.0
|
87.4 Titers
Interval 68.5 to 111.5
|
64.6 Titers
Interval 51.4 to 81.1
|
64.6 Titers
Interval 51.4 to 81.1
|
83.7 Titers
Interval 66.0 to 106.2
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu A/Uru/716/07 H3N2
|
89.5 Titers
Interval 65.8 to 121.8
|
87.7 Titers
Interval 64.0 to 120.3
|
87.1 Titers
Interval 61.4 to 123.5
|
87.8 Titers
Interval 63.4 to 121.4
|
110.0 Titers
Interval 79.3 to 152.6
|
127.2 Titers
Interval 92.3 to 175.5
|
—
|
|
Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.
Flu B/Bri/60/08 Victoria
|
339.9 Titers
Interval 276.7 to 417.5
|
273.8 Titers
Interval 228.7 to 327.9
|
245.4 Titers
Interval 197.8 to 304.3
|
292.6 Titers
Interval 247.0 to 346.7
|
369.6 Titers
Interval 300.0 to 455.3
|
378.4 Titers
Interval 323.4 to 442.8
|
—
|
Adverse Events
Flulaval/Placebo/Unadjuvanted Arepanrix Group
Serious events: 3 serious events
Other events: 92 other events
Deaths: 0 deaths
Flulaval/Placebo/Arepanrix Group
Serious events: 1 serious events
Other events: 91 other events
Deaths: 0 deaths
Flulaval/Unadjuvanted Arepanrix/Placebo Group
Serious events: 1 serious events
Other events: 86 other events
Deaths: 0 deaths
Flulaval/Arepanrix/Placebo Group
Serious events: 2 serious events
Other events: 97 other events
Deaths: 0 deaths
Unadjuvanted Arepanrix/Placebo/Flulaval Group
Serious events: 1 serious events
Other events: 84 other events
Deaths: 0 deaths
Arepanrix/Placebo/Flulaval Group
Serious events: 3 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 participants at risk
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 participants at risk
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 participants at risk
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 participants at risk
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 participants at risk
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 participants at risk
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.96%
1/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
1.0%
1/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.96%
1/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Hepatobiliary disorders
Jaundice
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.99%
1/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
1.0%
1/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
Other adverse events
| Measure |
Flulaval/Placebo/Unadjuvanted Arepanrix Group
n=102 participants at risk
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Placebo/Arepanrix Group
n=104 participants at risk
subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Unadjuvanted Arepanrix/Placebo Group
n=102 participants at risk
subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Flulaval/Arepanrix/Placebo Group
n=100 participants at risk
subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Unadjuvanted Arepanrix/Placebo/Flulaval Group
n=101 participants at risk
subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
Arepanrix/Placebo/Flulaval Group
n=102 participants at risk
subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
11/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
10.6%
11/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
10.8%
11/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
8.0%
8/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
14.9%
15/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
10.8%
11/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.8%
12/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
16.3%
17/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
8.8%
9/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
12.0%
12/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
5.9%
6/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
9.8%
10/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
9/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
10.6%
11/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
10.8%
11/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
6.0%
6/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
10.9%
11/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
4.9%
5/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.9%
7/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
6.7%
7/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
7.9%
8/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
4.9%
5/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
9.8%
10/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
6.9%
7/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
8.8%
9/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
7.7%
8/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
6.7%
7/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
6.0%
6/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Nervous system disorders
Headache
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
7.0%
7/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
5.9%
6/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/104 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
7.8%
8/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Pain
|
73.5%
75/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
89.0%
89/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
66.0%
66/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
94.9%
94/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
68.3%
69/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
95.0%
95/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Redness
|
2.0%
2/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
6.0%
6/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
1.0%
1/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
5.1%
5/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.99%
1/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
11.0%
11/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Swelling
|
2.0%
2/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
15.0%
15/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
2.0%
2/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
9.1%
9/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.00%
0/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
16.0%
16/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Fatigue
|
52.9%
54/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
62.0%
62/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
41.0%
41/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
58.6%
58/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
56.4%
57/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
56.0%
56/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Headache
|
51.0%
52/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
58.0%
58/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
51.0%
51/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
51.5%
51/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
48.5%
49/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
54.0%
54/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Joint pain at other location
|
23.5%
24/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
34.0%
34/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
24.0%
24/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
28.3%
28/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
25.7%
26/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
23.0%
23/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Muscle aches
|
37.3%
38/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
52.0%
52/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
39.0%
39/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
53.5%
53/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
42.6%
43/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
54.0%
54/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Shivering
|
20.6%
21/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
30.0%
30/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
19.0%
19/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
24.2%
24/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
20.8%
21/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
25.0%
25/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Sweating
|
21.6%
22/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
21.0%
21/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
21.0%
21/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
17.2%
17/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
11.9%
12/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
25.0%
25/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
|
General disorders
Temperature
|
2.9%
3/102 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
9.0%
9/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
3.0%
3/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
2.0%
2/99 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
0.99%
1/101 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
4.0%
4/100 • SAEs:during the entire study period (Days 0-329). Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period. Solicited symptoms: During a 7-day follow-up period (Days 0-6) after vaccination
SAEs were collected up to Day 329 which corresponds to the last contact day with the subjects reporting serious adverse events.
|
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