Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate (NCT NCT00363077)
NCT ID: NCT00363077
Last Updated: 2018-06-08
Results Overview
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
At Days 0 and 21
Results posted on
2018-06-08
Participant Flow
Participant milestones
| Measure |
GSK1247446A Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate
Baseline characteristics by cohort
| Measure |
GSK1247446A Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.4 Years
STANDARD_DEVIATION 4.22 • n=5 Participants
|
64.5 Years
STANDARD_DEVIATION 4.18 • n=7 Participants
|
64.4 Years
STANDARD_DEVIATION 4.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Outcome measures
| Measure |
GSK1247446A Group
n=74 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=74 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/New Caledonia, Day 0
|
45.3 titers
Interval 35.9 to 57.1
|
81.1 titers
Interval 61.5 to 106.8
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/New Caledonia, Day 21
|
116.4 titers
Interval 91.2 to 148.5
|
170.9 titers
Interval 132.7 to 220.3
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/Wisconsin, Day 0
|
28.8 titers
Interval 20.7 to 40.1
|
41.3 titers
Interval 29.1 to 58.6
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/Wisconsin, Day 21
|
251.9 titers
Interval 188.7 to 336.4
|
228.4 titers
Interval 168.5 to 309.6
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
B/Malaysia, Day 21
|
161.6 titers
Interval 131.4 to 198.6
|
131.4 titers
Interval 105.8 to 163.1
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
B/Malaysia, Day 0
|
27.1 titers
Interval 21.8 to 33.6
|
31.6 titers
Interval 25.1 to 39.8
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
GSK1247446A Group
n=74 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=74 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A/Wisconsin
|
52 subjects
|
40 subjects
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A/New Caledonia
|
21 subjects
|
12 subjects
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
B/Malaysia
|
46 subjects
|
31 subjects
|
PRIMARY outcome
Timeframe: At Day 0 and Day 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
GSK1247446A Group
n=74 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=74 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A/New Caledonia, Day 0
|
40 subjects
|
54 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A/Wisconsin, Day 0
|
35 subjects
|
44 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A/Wisconsin, Day 21
|
69 subjects
|
71 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A/New Caledonia, Day 21
|
68 subjects
|
73 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
B/Malaysia, Day 0
|
28 subjects
|
39 subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
B/Malaysia, Day 21
|
72 subjects
|
70 subjects
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
GSK1247446A Group
n=74 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=74 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/New Caledonia
|
2.6 fold increase
Interval 2.0 to 3.3
|
2.1 fold increase
Interval 1.6 to 2.8
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/Wisconsin
|
8.7 fold increase
Interval 6.3 to 12.1
|
5.5 fold increase
Interval 4.0 to 7.6
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
B/Malaysia
|
6.0 fold increase
Interval 4.6 to 7.8
|
4.2 fold increase
Interval 3.2 to 5.4
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
Outcome measures
| Measure |
GSK1247446A Group
n=73 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=73 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IFN-g, A/Wisconsin, Day 21 [N=73;73]
|
83.99 cytokine-positive cells/million cells
Standard Deviation 365.27
|
38.46 cytokine-positive cells/million cells
Standard Deviation 126.65
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
TNF-α, B/Malaysia, Day 21 [N=73;73]
|
1098.28 cytokine-positive cells/million cells
Standard Deviation 869.02
|
532.81 cytokine-positive cells/million cells
Standard Deviation 420.99
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
All Doubles, B/Malaysia, Day 0 [N=73;71]
|
436.58 cytokine-positive cells/million cells
Standard Deviation 348.81
|
451.35 cytokine-positive cells/million cells
Standard Deviation 448.35
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
All Doubles, B/Malaysia, Day 21 [N=73;73]
|
1555.92 cytokine-positive cells/million cells
Standard Deviation 1060.11
|
736.15 cytokine-positive cells/million cells
Standard Deviation 588.56
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
All Doubles, A/New Caledonia, Day 0 [N=73;71]
|
322.57 cytokine-positive cells/million cells
Standard Deviation 348.20
|
370.36 cytokine-positive cells/million cells
Standard Deviation 408.19
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
All Doubles, A/New Caledonia, Day 21 [N=73;73]
|
872.71 cytokine-positive cells/million cells
Standard Deviation 662.32
|
510.86 cytokine-positive cells/million cells
Standard Deviation 604.98
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
All Doubles, A/Wisconsin, Day 0 [N=73;71]
|
37.33 cytokine-positive cells/million cells
Standard Deviation 155.75
|
50.79 cytokine-positive cells/million cells
Standard Deviation 212.97
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
All Doubles, A/Wisconsin, Day 21 [N=73;73]
|
113.74 cytokine-positive cells/million cells
Standard Deviation 412.68
|
72.43 cytokine-positive cells/million cells
Standard Deviation 190.60
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
CD40L, B/Malaysia, Day 0 [N=73;71]
|
424.07 cytokine-positive cells/million cells
Standard Deviation 328.40
|
433.94 cytokine-positive cells/million cells
Standard Deviation 406.20
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
CD40L, B/Malaysia, Day 21 [N=73;73]
|
1409.79 cytokine-positive cells/million cells
Standard Deviation 983.81
|
694.68 cytokine-positive cells/million cells
Standard Deviation 550.36
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
CD40L, A/New Caledonia, Day 0 [N=73;71]
|
317.25 cytokine-positive cells/million cells
Standard Deviation 337.18
|
354.60 cytokine-positive cells/million cells
Standard Deviation 399.44
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
CD40L, A/New Caledonia, Day 21 [N=73;73]
|
786.97 cytokine-positive cells/million cells
Standard Deviation 598.31
|
475.96 cytokine-positive cells/million cells
Standard Deviation 576.45
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
CD40L, A/Wisconsin, Day 0 [N=73;71]
|
36.53 cytokine-positive cells/million cells
Standard Deviation 145.90
|
52.22 cytokine-positive cells/million cells
Standard Deviation 208.27
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
CD40L, A/Wisconsin, Day 21 [N=73;73]
|
97.23 cytokine-positive cells/million cells
Standard Deviation 346.59
|
65.37 cytokine-positive cells/million cells
Standard Deviation 168.16
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IFN-g, B/Malaysia, Day 0 [N=73;71]
|
265.46 cytokine-positive cells/million cells
Standard Deviation 297.90
|
244.30 cytokine-positive cells/million cells
Standard Deviation 377.07
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IFN-g, B/Malaysia, Day 21 [N=73;73]
|
1081.98 cytokine-positive cells/million cells
Standard Deviation 840.54
|
530.64 cytokine-positive cells/million cells
Standard Deviation 451.71
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IFN-g, A/New Caledonia, Day 0 [N=73;71]
|
225.76 cytokine-positive cells/million cells
Standard Deviation 265.96
|
239.78 cytokine-positive cells/million cells
Standard Deviation 285.26
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IFN-g, A/New Caledonia, Day 21 [N=73;73]
|
527.98 cytokine-positive cells/million cells
Standard Deviation 522.30
|
407.10 cytokine-positive cells/million cells
Standard Deviation 492.37
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IFN-g, A/Wisconsin, Day 0 [N=73;71]
|
24.45 cytokine-positive cells/million cells
Standard Deviation 114.69
|
30.49 cytokine-positive cells/million cells
Standard Deviation 83.91
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IL2, B/Malaysia, Day 0 [N=73;71]
|
379.42 cytokine-positive cells/million cells
Standard Deviation 318.77
|
382.48 cytokine-positive cells/million cells
Standard Deviation 378.85
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IL2, B/Malaysia, Day 21 [N=73;73]
|
1297.82 cytokine-positive cells/million cells
Standard Deviation 880.34
|
647.93 cytokine-positive cells/million cells
Standard Deviation 508.83
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IL2, A/New Caledonia, Day 0 [N=73;71]
|
256.57 cytokine-positive cells/million cells
Standard Deviation 307.83
|
220.62 cytokine-positive cells/million cells
Standard Deviation 301.07
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IL2, A/New Caledonia, Day 21 [N=73;73]
|
652.75 cytokine-positive cells/million cells
Standard Deviation 539.89
|
300.71 cytokine-positive cells/million cells
Standard Deviation 502.30
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IL2, A/Wisconsin, Day 0 [N=73;71]
|
31.74 cytokine-positive cells/million cells
Standard Deviation 130.05
|
53.93 cytokine-positive cells/million cells
Standard Deviation 127.47
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
IL2, A/Wisconsin, Day 21 [N=73;73]
|
89.97 cytokine-positive cells/million cells
Standard Deviation 301.28
|
53.47 cytokine-positive cells/million cells
Standard Deviation 148.09
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
TNF-α, B/Malaysia, Day 0 [N=73;71]
|
332.83 cytokine-positive cells/million cells
Standard Deviation 298.11
|
331.52 cytokine-positive cells/million cells
Standard Deviation 383.96
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
TNF-α, A/New Caledonia, Day 0 [N=73;71]
|
219.03 cytokine-positive cells/million cells
Standard Deviation 276.48
|
261.91 cytokine-positive cells/million cells
Standard Deviation 369.60
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
TNF-α, A/New Caledonia, Day 21 [N=73;73]
|
582.62 cytokine-positive cells/million cells
Standard Deviation 506.95
|
317.96 cytokine-positive cells/million cells
Standard Deviation 416.78
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
TNF-α, A/Wisconsin, Day 0 [N=73;71]
|
23.29 cytokine-positive cells/million cells
Standard Deviation 119.05
|
36.16 cytokine-positive cells/million cells
Standard Deviation 190.06
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
TNF-α, A/Wisconsin, Day 21 [N=73;73]
|
84.99 cytokine-positive cells/million cells
Standard Deviation 308.52
|
44.97 cytokine-positive cells/million cells
Standard Deviation 157.29
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
Outcome measures
| Measure |
GSK1247446A Group
n=73 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=73 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
All doubles, B/Malaysia, Day 0 [N=72;69]
|
7.91 cytokine-positive cells/million cells
Standard Deviation 83.49
|
4.17 cytokine-positive cells/million cells
Standard Deviation 70.59
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
All doubles, A/New Caledonia, Day 21 [N=73;70]
|
7.81 cytokine-positive cells/million cells
Standard Deviation 191.24
|
4.40 cytokine-positive cells/million cells
Standard Deviation 141.07
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
CD40L, A/Wisconsin, Day 0 [N=72;69]
|
2.15 cytokine-positive cells/million cells
Standard Deviation 53.59
|
2.70 cytokine-positive cells/million cells
Standard Deviation 44.68
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
CD40L, A/Wisconsin, Day 21 [N=73;73]
|
2.18 cytokine-positive cells/million cells
Standard Deviation 39.28
|
2.11 cytokine-positive cells/million cells
Standard Deviation 39.64
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IFN-g, A/New Caledonia, Day 0 [N=71;69]
|
5.67 cytokine-positive cells/million cells
Standard Deviation 231.67
|
4.34 cytokine-positive cells/million cells
Standard Deviation 97.73
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IFN-g, A/New Caledonia, Day 21 [N=73;70]
|
5.04 cytokine-positive cells/million cells
Standard Deviation 174.85
|
3.98 cytokine-positive cells/million cells
Standard Deviation 133.45
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IL2, A/Wisconsin, Day 21 [N=73;73]
|
2.76 cytokine-positive cells/million cells
Standard Deviation 45.28
|
2.55 cytokine-positive cells/million cells
Standard Deviation 61.31
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
All doubles, B/Malaysia, Day 21 [N=73;72]
|
7.82 cytokine-positive cells/million cells
Standard Deviation 95.80
|
3.74 cytokine-positive cells/million cells
Standard Deviation 120.67
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
All doubles, A/New Caledonia, Day 0 [N=71;69]
|
6.22 cytokine-positive cells/million cells
Standard Deviation 233.32
|
7.31 cytokine-positive cells/million cells
Standard Deviation 112.56
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
All doubles, A/Wisconsin, Day 0 [N=72;69]
|
3.93 cytokine-positive cells/million cells
Standard Deviation 82.82
|
6.79 cytokine-positive cells/million cells
Standard Deviation 85.90
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
All doubles, A/Wisconsin, Day 21 [N=73;73]
|
3.35 cytokine-positive cells/million cells
Standard Deviation 56.70
|
2.79 cytokine-positive cells/million cells
Standard Deviation 70.15
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
CD40L, B/Malaysia, Day 0 [N=72;69]
|
2.20 cytokine-positive cells/million cells
Standard Deviation 34.98
|
2.11 cytokine-positive cells/million cells
Standard Deviation 36.15
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
CD40L, B/Malaysia, Day 21 [N=73;72]
|
3.66 cytokine-positive cells/million cells
Standard Deviation 45.91
|
1.98 cytokine-positive cells/million cells
Standard Deviation 32.45
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
CD40L, A/New Caledonia, Day 0 [N=71;69]
|
2.56 cytokine-positive cells/million cells
Standard Deviation 113.11
|
5.34 cytokine-positive cells/million cells
Standard Deviation 65.09
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
CD40L, A/New Caledonia, Day 21 [N=73;70]
|
4.17 cytokine-positive cells/million cells
Standard Deviation 93.16
|
2.11 cytokine-positive cells/million cells
Standard Deviation 51.19
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IFN-g, B/Malaysia, Day 0 [N=72;69]
|
4.28 cytokine-positive cells/million cells
Standard Deviation 56.03
|
2.71 cytokine-positive cells/million cells
Standard Deviation 56.13
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IFN-g, B/Malaysia, Day 21 [N=73;72]
|
6.24 cytokine-positive cells/million cells
Standard Deviation 74.51
|
3.53 cytokine-positive cells/million cells
Standard Deviation 118.94
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IFN-g, A/Wisconsin, Day 0 [N=72;69]
|
2.84 cytokine-positive cells/million cells
Standard Deviation 73.55
|
4.40 cytokine-positive cells/million cells
Standard Deviation 69.48
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IFN-g, A/Wisconsin, Day 21 [N=73;73]
|
2.46 cytokine-positive cells/million cells
Standard Deviation 44.69
|
1.98 cytokine-positive cells/million cells
Standard Deviation 36.44
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IL2, B/Malaysia, Day 0 [N=72;69]
|
3.60 cytokine-positive cells/million cells
Standard Deviation 92.44
|
2.12 cytokine-positive cells/million cells
Standard Deviation 44.04
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IL2, B/Malaysia, Day 21 [N=73;72]
|
3.45 cytokine-positive cells/million cells
Standard Deviation 60.32
|
2.44 cytokine-positive cells/million cells
Standard Deviation 32.77
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IL2, A/New Caledonia, Day 0 [N=71;69]
|
2.48 cytokine-positive cells/million cells
Standard Deviation 131.52
|
4.43 cytokine-positive cells/million cells
Standard Deviation 60.02
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IL2, A/New Caledonia, Day 21 [N=73;70]
|
4.63 cytokine-positive cells/million cells
Standard Deviation 125.59
|
2.44 cytokine-positive cells/million cells
Standard Deviation 62.17
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
IL2, A/Wisconsin, Day 0 [N=72;69]
|
1.93 cytokine-positive cells/million cells
Standard Deviation 55.19
|
3.23 cytokine-positive cells/million cells
Standard Deviation 61.15
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
TNF-α, B/Malaysia, Day 0 [N=72;69]
|
8.41 cytokine-positive cells/million cells
Standard Deviation 83.63
|
4.29 cytokine-positive cells/million cells
Standard Deviation 78.46
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
TNF-α, B/Malaysia, Day 21 [N=73;72]
|
6.25 cytokine-positive cells/million cells
Standard Deviation 91.95
|
3.90 cytokine-positive cells/million cells
Standard Deviation 124.66
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
TNF-α, A/New Caledonia, Day 0 [N=71;69]
|
6.07 cytokine-positive cells/million cells
Standard Deviation 218.59
|
6.05 cytokine-positive cells/million cells
Standard Deviation 114.14
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
TNF-α, A/New Caledonia, Day 21 [N=73;70]
|
8.15 cytokine-positive cells/million cells
Standard Deviation 171.91
|
5.50 cytokine-positive cells/million cells
Standard Deviation 128.58
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
TNF-α, A/Wisconsin, Day 0 [N=72;69]
|
3.12 cytokine-positive cells/million cells
Standard Deviation 58.61
|
5.55 cytokine-positive cells/million cells
Standard Deviation 92.14
|
|
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
TNF-α, A/Wisconsin, Day 21 [N=73;73]
|
2.56 cytokine-positive cells/million cells
Standard Deviation 49.21
|
2.33 cytokine-positive cells/million cells
Standard Deviation 70.96
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.
Outcome measures
| Measure |
GSK1247446A Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Ecchymosis
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Ecchymosis > 50 mm
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Swelling > 50 mm
|
3 subjects
|
1 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Pain
|
57 subjects
|
25 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Grade 3 Pain
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Redness
|
14 subjects
|
8 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Redness > 50 mm
|
4 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Any Swelling
|
18 subjects
|
5 subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Outcome measures
| Measure |
GSK1247446A Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue
|
29 subjects
|
12 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Arthralgia
|
12 subjects
|
8 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Arthralgia
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Arthralgia
|
10 subjects
|
4 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue
|
30 subjects
|
13 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever ≥ 37.5°C
|
2 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever > 39.0°C
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fever
|
2 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache
|
28 subjects
|
10 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache
|
24 subjects
|
7 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Muscle aches
|
17 subjects
|
10 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Muscle aches
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Muscle aches
|
15 subjects
|
8 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering
|
10 subjects
|
3 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering
|
9 subjects
|
3 subjects
|
SECONDARY outcome
Timeframe: During the 30-day (Days 0-29) post vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1247446A Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with any AE(s)
|
31 subjects
|
22 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with grade 3 AE(s)
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with related AE(s)
|
11 subjects
|
7 subjects
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 to Day 29)Population: The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE considered by the investigator to have a causal relationship to study vaccination.
Outcome measures
| Measure |
GSK1247446A Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=75 Participants
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Subjects with any SAE(s)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Subjects with related SAE(s)
|
0 subjects
|
0 subjects
|
Adverse Events
GSK1247446A Group
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Fluarix Group
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1247446A Group
n=75 participants at risk
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=75 participants at risk
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
1.3%
1/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
Other adverse events
| Measure |
GSK1247446A Group
n=75 participants at risk
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Fluarix Group
n=75 participants at risk
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.3%
7/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
5.3%
4/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
General disorders
Influenza like illness
|
2.7%
2/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
5.3%
4/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.3%
4/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
1.3%
1/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
General disorders
Pain
|
76.0%
57/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
33.3%
25/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
General disorders
Redness
|
18.7%
14/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
10.7%
8/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
General disorders
Swelling
|
24.0%
18/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
6.7%
5/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
General disorders
Arthralgia
|
16.0%
12/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
10.7%
8/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
General disorders
Fatigue
|
40.0%
30/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
17.3%
13/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
General disorders
Headache
|
37.3%
28/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
13.3%
10/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
General disorders
Muscle aches
|
22.7%
17/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
13.3%
10/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
|
General disorders
Shivering
|
13.3%
10/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
4.0%
3/75 • SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
|
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