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A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

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ClinicalTrials.gov Identifier: NCT01196975
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : December 24, 2012
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
Biological: FluLavalTM-VB
Biological: FluLavalTM-YB
Enrollment 1707
Recruitment Details 1703 of the 1707 subjects enrolled in the study were actually administered vaccination. The other 4 subjects were not vaccinated due to failing at meeting protocol specific criteria.
Pre-assignment Details For some outcome measures, the subjects receiving the GSK2282512A vaccine, from Lot 1, 2 or 3, were pooled into one larger pooled group, the GSK2282512A Group, and/or groups were stratified into the 4 age categories: 18 to 60 years (18-60Y), 61 years and older (≥61Y), 18 to 64 years (18-64Y), and 65 years and older (≥ 65Y).
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 423 424 425 213 218
Completed 408 415 420 207 205
Not Completed 15 9 5 6 13
Reason Not Completed
Adverse Event             2             2             0             0             2
Withdrawal by Subject             2             1             0             1             0
Lost to Follow-up             11             6             5             5             11
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group Total
Hide Arm/Group Description Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 423 424 425 213 218 1703
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 423 participants 424 participants 425 participants 213 participants 218 participants 1703 participants
49.9  (19.49) 50.4  (19.07) 49.8  (20.10) 50.8  (18.58) 49.6  (19.34) 50.1  (19.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 423 participants 424 participants 425 participants 213 participants 218 participants 1703 participants
Female
251
  59.3%
264
  62.3%
266
  62.6%
125
  58.7%
138
  63.3%
1044
  61.3%
Male
172
  40.7%
160
  37.7%
159
  37.4%
88
  41.3%
80
  36.7%
659
  38.7%
1.Primary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Hide Description Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.
Time Frame At Day 0 (D0) and at Day 21 (D21) post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Yamagata Strain FluLaval Group - Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 1246 204 211
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
H1N1, D0 Number Analyzed 1238 participants 204 participants 211 participants
16.9
(15.7 to 18.2)
19.1
(15.8 to 23.1)
16.5
(13.9 to 19.6)
H1N1, D21 Number Analyzed 1246 participants 204 participants 210 participants
204.6
(190.4 to 219.9)
176.0
(149.1 to 207.7)
149.0
(122.9 to 180.7)
H3N1, D0 Number Analyzed 1238 participants 204 participants 211 participants
16.0
(15.0 to 17.1)
13.9
(11.8 to 16.4)
14.9
(12.7 to 17.5)
H3N1, D21 Number Analyzed 1245 participants 204 participants 211 participants
125.4
(117.4 to 133.9)
147.5
(124.1 to 175.2)
141.0
(118.1 to 168.3)
BRI, D0 Number Analyzed 1240 participants 203 participants 211 participants
27.9
(26.0 to 30.0)
29.4
(24.7 to 35.0)
26.7
(22.8 to 31.4)
BRI, D21 Number Analyzed 1246 participants 204 participants 210 participants
177.7
(167.8 to 188.1)
135.9
(118.1 to 156.5)
71.9
(61.3 to 84.2)
FLO, D0 Number Analyzed 1241 participants 204 participants 211 participants
76.2
(71.1 to 81.5)
68.1
(58.5 to 79.2)
70.3
(59.8 to 82.6)
FLO, D21 Number Analyzed 1246 participants 204 participants 211 participants
399.7
(378.1 to 422.6)
176.9
(153.8 to 203.5)
306.6
(266.2 to 353.3)
2.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
Hide Description Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.
Time Frame At Day 0 (D0) and at Day 21 (D21) post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A 18-64Y Group GSK2282512A ≥ 65Y Group Victoria Strain FluLaval 18-64Y Group Victoria Strain FluLaval ≥ 65Y Group Yamagata Strain FluLaval 18-64Y Group Yamagata Strain FluLaval ≥ 65Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 849 397 136 68 144 68
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
H1N1, D0 Number Analyzed 844 participants 394 participants 136 participants 68 participants 144 participants 67 participants
19.0
(17.4 to 20.9)
13.2
(11.7 to 14.7)
20.3
(16.0 to 25.8)
16.8
(12.3 to 22.9)
18.7
(15.0 to 23.2)
12.6
(9.6 to 16.5)
H1N1, D21 Number Analyzed 849 participants 397 participants 136 participants 68 participants 143 participants 67 participants
289.4
(267.9 to 312.7)
97.4
(85.9 to 110.5)
236.9
(199.7 to 281.1)
97.1
(70.3 to 134.1)
198.5
(161.7 to 243.7)
80.8
(55.1 to 118.5)
H3N1, D0 Number Analyzed 844 participants 394 participants 136 participants 68 participants 144 participants 67 participants
15.2
(14.0 to 16.6)
17.8
(15.9 to 19.9)
15.0
(12.1 to 18.4)
12.0
(9.1 to 15.8)
14.8
(12.1 to 18.1)
15.1
(11.6 to 19.7)
H3N1, D21 Number Analyzed 849 participants 396 participants 136 participants 68 participants 144 participants 67 participants
136.1
(125.9 to 147.2)
105.1
(93.4 to 118.3)
176.3
(144.3 to 215.4)
103.2
(75.1 to 141.8)
173.6
(142.5 to 211.6)
90.1
(63.8 to 127.3)
BRI, D0 Number Analyzed 843 participants 397 participants 135 participants 68 participants 144 participants 67 participants
21.7
(19.9 to 23.7)
47.9
(42.8 to 53.5)
23.8
(19.1 to 29.6)
44.7
(34.1 to 58.6)
22.8
(18.7 to 27.8)
37.6
(28.8 to 49.1)
BRI, D21 Number Analyzed 849 participants 397 participants 136 participants 68 participants 143 participants 67 participants
199.3
(185.9 to 213.6)
139.0
(126.2 to 153.1)
157.2
(131.5 to 187.9)
101.6
(81.8 to 126.1)
75.1
(61.2 to 92.2)
65.4
(51.3 to 83.4)
FLO, D0 Number Analyzed 844 participants 397 participants 136 participants 68 participants 144 participants 67 participants
70.7
(64.8 to 77.2)
89.1
(80.2 to 98.9)
66.1
(54.3 to 80.4)
72.2
(57.2 to 91.2)
67.6
(54.8 to 83.4)
76.3
(59.9 to 97.3)
FLO, D21 Number Analyzed 849 participants 397 participants 136 participants 68 participants 144 participants 67 participants
475.3
(444.2 to 508.5)
276.1
(252.8 to 301.5)
204.9
(171.3 to 245.0)
131.8
(107.1 to 162.3)
406.1
(347.3 to 474.9)
167.7
(132.0 to 212.9)
3.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
Hide Description Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.
Time Frame At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol with available assay results for assessed antibodies in Day 180 blood samples.
Arm/Group Title GSK2282512A 18-60Y Group GSK2282512A ≥ 61Y Group Victoria Strain FluLaval 18-60Y Group Victoria Strain FluLaval ≥ 61Y Group Yamagata Strain FluLaval 18-60Y Group Yamagata Strain FluLaval ≥ 61Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 122 135 17 20 22 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
H1N1, D0 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
23.1
(17.9 to 29.8)
12.0
(9.9 to 14.5)
22.6
(11.6 to 44.0)
18.7
(8.7 to 39.9)
17.9
(10.0 to 32.1)
10.2
(6.1 to 17.0)
H1N1, D21 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
302.4
(245.8 to 372.0)
105.0
(83.6 to 131.9)
369.1
(216.2 to 630.0)
132.2
(64.5 to 270.7)
187.4
(110.4 to 318.2)
81.4
(34.2 to 194.1)
H1N1, D180 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
97.9
(80.3 to 119.3)
29.1
(23.4 to 36.2)
104.2
(57.0 to 190.5)
55.6
(29.3 to 105.6)
57.5
(33.2 to 99.4)
34.8
(16.2 to 74.8)
H3N1, D0 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
15.5
(12.3 to 19.4)
17.9
(14.7 to 21.8)
12.0
(7.3 to 19.7)
16.8
(9.1 to 30.9)
12.7
(7.7 to 20.7)
17.1
(9.9 to 29.6)
H3N1, D21 Number Analyzed 122 participants 134 participants 17 participants 20 participants 22 participants 20 participants
123.2
(100.4 to 151.2)
119.8
(97.6 to 147.0)
163.3
(103.0 to 258.8)
168.4
(82.1 to 345.6)
175.9
(110.7 to 279.3)
157.2
(92.3 to 267.9)
H3N1, D180 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
40.9
(33.5 to 49.9)
43.3
(36.7 to 51.1)
46.1
(31.8 to 67.0)
46.7
(27.6 to 79.0)
63.0
(39.5 to 100.8)
60.6
(35.1 to 104.6)
BRI, D0 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
22.9
(18.3 to 28.6)
41.1
(33.9 to 49.8)
30.7
(16.1 to 58.6)
42.9
(25.4 to 72.3)
17.9
(11.7 to 27.3)
32.5
(18.0 to 58.6)
BRI, D21 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
193.0
(161.0 to 231.4)
167.2
(141.6 to 197.3)
180.9
(120.9 to 270.7)
109.3
(77.7 to 153.6)
53.9
(31.0 to 93.6)
74.7
(44.7 to 124.9)
BRI, D180 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
112.8
(94.1 to 135.3)
127.0
(109.1 to 147.8)
130.5
(91.8 to 185.4)
102.0
(78.8 to 132.0)
59.3
(36.9 to 95.4)
79.9
(49.8 to 128.5)
FLO, D0 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
75.4
(59.3 to 95.8)
79.2
(65.5 to 95.7)
92.3
(54.5 to 156.4)
93.5
(54.0 to 161.7)
60.3
(38.7 to 93.9)
78.6
(41.6 to 148.3)
FLO, D21 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
485.8
(407.3 to 579.5)
334.3
(288.9 to 386.8)
204.4
(134.8 to 310.0)
187.0
(138.5 to 252.3)
405.3
(273.8 to 600.0)
180.6
(101.4 to 321.7)
FLO, D180 Number Analyzed 122 participants 135 participants 17 participants 20 participants 22 participants 20 participants
311.9
(261.7 to 371.7)
209.5
(183.0 to 239.8)
177.3
(120.5 to 260.9)
160.1
(108.8 to 235.6)
320.1
(207.8 to 492.9)
174.3
(104.3 to 291.2)
4.Secondary Outcome
Title Number of Subjects With Medically-attended Adverse Events (MAEs)
Hide Description Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE.
Time Frame From the beginning of the study until study end (from Day 0 to Day 180)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on subjects with available results.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 423 424 425 213 218
Measure Type: Count of Participants
Unit of Measure: Participants
129
  30.5%
101
  23.8%
100
  23.5%
51
  23.9%
64
  29.4%
5.Secondary Outcome
Title Number of Subjects With Related Medically-attended Adverse Events (MAEs)
Hide Description Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE. Related MAE = MAE assessed by the investigator to be causally related to vaccination. Relationship to vaccination was not computed for MAEs.
Time Frame From the beginning of the study until study end (from Day 0 to Day 180) .
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on subjects with available results.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator to be causally related to vaccination.
Time Frame From the beginning of the study until study end (from Day 0 to Day 180) .
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on subjects with available results.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 423 424 425 213 218
Measure Type: Count of Participants
Unit of Measure: Participants
Subject(s) with Any pIMD(s)
1
   0.2%
1
   0.2%
1
   0.2%
0
   0.0%
1
   0.5%
Subject(s) with Related pIMD(s)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Hide Description Serious adverse events (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.
Time Frame From the beginning of the study until study end (from Day 0 to Day 180)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 423 424 425 213 218
Measure Type: Count of Participants
Unit of Measure: Participants
Subject(s) with Any SAE(s)
15
   3.5%
13
   3.1%
7
   1.6%
3
   1.4%
7
   3.2%
Subject(s) with Related SAE(s)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
Hide Description Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.
Time Frame At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.
Arm/Group Title GSK2282512A 18-64Y Group GSK2282512A ≥ 65Y Group Victoria Strain FluLaval 18-64Y Group Victoria Strain FluLaval ≥ 65Y Group Yamagata Strain FluLaval 18-64Y Group Yamagata Strain FluLaval ≥ 65Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 131 126 18 19 23 19
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
H1N1, D0 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
22.7
(17.8 to 29.0)
11.6
(9.6 to 14.2)
23.3
(12.4 to 43.7)
17.9
(8.1 to 39.8)
18.0
(10.3 to 31.4)
9.8
(5.7 to 16.8)
H1N1, D21 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
293.3
(240.7 to 357.3)
100.5
(79.1 to 127.7)
339.0
(199.0 to 577.6)
135.7
(63.7 to 289.2)
180.6
(108.4 to 300.8)
81.5
(32.5 to 204.3)
H1N1, D180 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
95.5
(79.1 to 115.3)
27.4
(21.8 to 34.4)
98.8
(55.5 to 176.0)
56.6
(28.7 to 111.4)
56.6
(33.5 to 95.4)
34.5
(15.4 to 77.6)
H3N1, D0 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
15.3
(12.2 to 19.1)
18.4
(15.1 to 22.3)
13.3
(8.0 to 22.4)
15.5
(8.3 to 28.8)
12.2
(7.5 to 19.6)
18.2
(10.4 to 32.2)
H3N1, D21 Number Analyzed 131 participants 125 participants 18 participants 19 participants 23 participants 19 participants
115.0
(93.2 to 141.9)
128.6
(105.4 to 156.8)
163.1
(105.8 to 251.3)
168.9
(79.0 to 361.3)
175.1
(112.7 to 272.2)
157.1
(89.4 to 276.0)
H3N1, D180 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
41.3
(34.0 to 50.0)
43.1
(36.3 to 51.0)
49.4
(33.8 to 72.2)
43.8
(25.6 to 74.9)
61.9
(39.5 to 96.9)
61.9
(34.8 to 110.1)
BRI, D0 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
23.1
(18.6 to 28.6)
42.5
(34.8 to 51.8)
29.9
(16.3 to 55.1)
44.6
(25.9 to 77.0)
19.7
(12.6 to 30.8)
29.9
(16.5 to 54.2)
BRI, D21 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
183.6
(154.3 to 218.6)
174.3
(146.6 to 207.1)
166.4
(109.6 to 252.5)
115.2
(81.9 to 162.0)
56.5
(33.1 to 96.5)
71.8
(41.9 to 122.8)
BRI, D180 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
111.1
(93.6 to 131.8)
130.2
(111.0 to 152.7)
124.6
(88.4 to 175.7)
105.2
(80.8 to 137.0)
63.8
(39.6 to 102.9)
74.3
(46.2 to 119.5)
FLO, D0 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
78.5
(62.4 to 98.8)
76.1
(62.6 to 92.6)
98.9
(59.1 to 165.6)
87.6
(50.0 to 153.7)
64.8
(41.4 to 101.5)
73.0
(38.0 to 140.0)
FLO, D21 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
473.4
(399.7 to 560.6)
334.4
(287.4 to 389.1)
209.5
(141.3 to 310.8)
181.7
(133.2 to 248.0)
401.2
(275.9 to 583.3)
175.3
(95.5 to 321.6)
FLO, D180 Number Analyzed 131 participants 126 participants 18 participants 19 participants 23 participants 19 participants
314.1
(266.4 to 370.4)
202.1
(175.6 to 232.7)
190.4
(128.6 to 281.9)
148.8
(102.3 to 216.6)
329.9
(217.6 to 500.1)
162.8
(96.6 to 274.2)
9.Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
Hide Description A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains
Time Frame At Day 0 (D0) and at Day 21 (D21) after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 1246 204 211
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1, D0 Number Analyzed 1238 participants 204 participants 211 participants
423
  34.2%
78
  38.2%
63
  29.9%
H1N1, D21 Number Analyzed 1246 participants 204 participants 210 participants
1168
  93.7%
189
  92.6%
182
  86.7%
H3N1, D0 Number Analyzed 1238 participants 204 participants 211 participants
385
  31.1%
55
  27.0%
64
  30.3%
H3N1, D21 Number Analyzed 1245 participants 204 participants 211 participants
1130
  90.8%
188
  92.2%
193
  91.5%
BRI, D0 Number Analyzed 1240 participants 204 participants 211 participants
635
  51.2%
103
  50.5%
98
  46.4%
BRI, D21 Number Analyzed 1246 participants 204 participants 210 participants
1201
  96.4%
193
  94.6%
167
  79.5%
FLO, D0 Number Analyzed 1241 participants 204 participants 211 participants
997
  80.3%
162
  79.4%
168
  79.6%
FLO, D21 Number Analyzed 1246 participants 204 participants 211 participants
1244
  99.8%
200
  98.0%
207
  98.1%
10.Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata
Hide Description A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.
Time Frame At Day 0 (D0) and at Day 21 (D21) after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A 18-60Y Group GSK2282512A ≥ 61Y Group Victoria Strain FluLaval 18-60Y Group Victoria Strain FluLaval ≥ 61Y Group Yamagata Strain FluLaval 18-60Y Group Yamagata Strain FluLaval ≥ 61Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 780 466 127 77 135 76
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1, D0 Number Analyzed 775 participants 463 participants 127 participants 77 participants 135 participants 76 participants
309
  39.9%
114
  24.6%
51
  40.2%
27
  35.1%
50
  37.0%
13
  17.1%
H1N1, D21 Number Analyzed 780 participants 466 participants 127 participants 77 participants 135 participants 75 participants
765
  98.1%
403
  86.5%
125
  98.4%
64
  83.1%
127
  94.1%
55
  73.3%
H3N1, D0 Number Analyzed 775 participants 463 participants 127 participants 77 participants 135 participants 76 participants
229
  29.5%
156
  33.7%
38
  29.9%
17
  22.1%
40
  29.6%
24
  31.6%
H3N1, D21 Number Analyzed 780 participants 465 participants 127 participants 77 participants 135 participants 76 participants
726
  93.1%
404
  86.9%
122
  96.1%
66
  85.7%
130
  96.3%
63
  82.9%
BRI, D0 Number Analyzed 774 participants 466 participants 126 participants 77 participants 135 participants 76 participants
338
  43.7%
297
  63.7%
52
  41.3%
51
  66.2%
53
  39.3%
45
  59.2%
BRI, D21 Number Analyzed 780 participants 466 participants 127 participants 77 participants 135 participants 75 participants
760
  97.4%
441
  94.6%
121
  95.3%
72
  93.5%
107
  79.3%
60
  80.0%
FLO, D0 Number Analyzed 775 participants 466 participants 127 participants 77 participants 135 participants 76 participants
591
  76.3%
406
  87.1%
99
  78.0%
63
  81.8%
105
  77.8%
63
  82.9%
FLO, D21 Number Analyzed 780 participants 466 participants 127 participants 77 participants 135 participants 76 participants
779
  99.9%
465
  99.8%
125
  98.4%
75
  97.4%
134
  99.3%
73
  96.1%
11.Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata
Hide Description A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.
Time Frame At Day 0 (D0) and at Day 21 (D21) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A 18-64Y Group GSK2282512A ≥ 65Y Group Victoria Strain FluLaval 18-64Y Group Victoria Strain FluLaval ≥ 65Y Group Yamagata Strain FluLaval 18-64Y Group Yamagata Strain FluLaval ≥ 65Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 849 397 136 68 144 67
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1, D0 Number Analyzed 844 participants 394 participants 136 participants 68 participants 144 participants 67 participants
330
  39.1%
93
  23.6%
55
  40.4%
23
  33.8%
51
  35.4%
12
  17.9%
H1N1, D21 Number Analyzed 849 participants 397 participants 136 participants 68 participants 143 participants 67 participants
830
  97.8%
338
  85.1%
134
  98.5%
55
  80.9%
132
  92.3%
50
  74.6%
H3N1, D0 Number Analyzed 844 participants 394 participants 136 participants 68 participants 144 participants 67 participants
251
  29.7%
134
  34.0%
40
  29.4%
15
  22.1%
42
  29.2%
22
  32.8%
H3N1, D21 Number Analyzed 849 participants 396 participants 136 participants 68 participants 144 participants 67 participants
784
  92.3%
346
  87.4%
129
  94.9%
59
  86.8%
137
  95.1%
56
  83.6%
BRI, D0 Number Analyzed 843 participants 397 participants 135 participants 68 participants 144 participants 67 participants
366
  43.4%
269
  67.8%
55
  40.7%
48
  70.6%
59
  41.0%
39
  58.2%
BRI, D21 Number Analyzed 849 participants 397 participants 136 participants 68 participants 143 participants 67 participants
826
  97.3%
375
  94.5%
130
  95.6%
63
  92.6%
114
  79.7%
53
  79.1%
FLO, D0 Number Analyzed 844 participants 397 participants 136 participants 68 participants 144 participants 67 participants
650
  77.0%
347
  87.4%
105
  77.2%
57
  83.8%
112
  77.8%
56
  83.6%
FLO, D21 Number Analyzed 849 participants 397 participants 136 participants 68 participants 144 participants 67 participants
848
  99.9%
396
  99.7%
134
  98.5%
66
  97.1%
143
  99.3%
64
  95.5%
12.Secondary Outcome
Title Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata
Hide Description 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 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.
Time Frame At Day 21 (D21) after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A 18-64Y Group GSK2282512A ≥ 65Y Group Victoria Strain FluLaval 18-64Y Group Victoria Strain FluLaval ≥ 65Y Group Yamagata Strain FluLaval 18-64Y Group Yamagata Strain FluLaval ≥ 65Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 844 397 136 68 144 67
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1, D21 Number Analyzed 844 participants 394 participants 136 participants 68 participants 143 participants 67 participants
667
  79.0%
255
  64.7%
101
  74.3%
35
  51.5%
102
  71.3%
36
  53.7%
H3N1, D21 Number Analyzed 844 participants 393 participants 136 participants 68 participants 144 participants 67 participants
584
  69.2%
239
  60.8%
104
  76.5%
45
  66.2%
109
  75.7%
40
  59.7%
BRI, D21 Number Analyzed 843 participants 397 participants 135 participants 68 participants 143 participants 67 participants
561
  66.5%
124
  31.2%
80
  59.3%
19
  27.9%
52
  36.4%
10
  14.9%
FLO, D21 Number Analyzed 844 participants 397 participants 136 participants 68 participants 144 participants 67 participants
533
  63.2%
147
  37.0%
55
  40.4%
13
  19.1%
90
  62.5%
17
  25.4%
13.Secondary Outcome
Title Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
Hide Description 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 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.
Time Frame At Day 21 (D21) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A 18-64Y Group GSK2282512A ≥ 65Y Group Victoria Strain FluLaval 18-64Y Group Victoria Strain FluLaval ≥ 65Y Group Yamagata Strain FluLaval 18-64Y Group Yamagata Strain FluLaval ≥ 65Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 844 397 136 68 144 67
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
SCF - H1N1, D21 Number Analyzed 844 participants 394 participants 136 participants 68 participants 143 participants 67 participants
15.2
(13.7 to 16.9)
7.4
(6.4 to 8.4)
11.7
(9.0 to 15.1)
5.8
(4.0 to 8.3)
10.5
(8.2 to 13.4)
6.4
(4.3 to 9.5)
SCF - H3N1, D21 Number Analyzed 844 participants 393 participants 136 participants 68 participants 144 participants 67 participants
8.9
(8.1 to 9.8)
5.9
(5.2 to 6.7)
11.8
(9.2 to 15.1)
8.6
(5.9 to 12.4)
11.7
(9.1 to 15.1)
6.0
(4.3 to 8.3)
SCF - BRI, D21 Number Analyzed 843 participants 397 participants 135 participants 68 participants 143 participants 67 participants
9.2
(8.3 to 10.1)
2.9
(2.6 to 3.2)
6.5
(5.1 to 8.3)
2.3
(1.8 to 2.9)
3.3
(2.7 to 4.1)
1.7
(1.4 to 2.2)
SCF - FLO, D21 Number Analyzed 844 participants 397 participants 136 participants 68 participants 144 participants 67 participants
6.7
(6.1 to 7.4)
3.1
(2.8 to 3.4)
3.1
(2.6 to 3.7)
1.8
(1.5 to 2.3)
6.0
(4.8 to 7.5)
2.2
(1.8 to 2.7)
14.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
Hide Description Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.
Time Frame At Day 0 (D0) and at Day 21 (D21) post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A 18-60Y Group GSK2282512A ≥ 61Y Group Victoria Strain FluLaval 18-60Y Group Victoria Strain FluLaval ≥ 61Y Group Yamagata Strain FluLaval 18-60Y Group Yamagata Strain FluLaval ≥ 61Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 780 466 127 77 135 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
H1N1, D0 Number Analyzed 775 participants 463 participants 127 participants 77 participants 135 participants 76 participants
19.5
(17.7 to 21.5)
13.4
(12.0 to 14.9)
20.7
(16.1 to 26.6)
16.6
(12.4 to 22.3)
19.3
(15.4 to 24.2)
12.5
(9.7 to 16.1)
H1N1, D21 Number Analyzed 780 participants 466 participants 127 participants 77 participants 135 participants 75 participants
306.9
(283.3 to 332.5)
103.8
(92.6 to 116.3)
248.3
(207.8 to 296.6)
99.7
(74.7 to 133.2)
212.2
(175.2 to 257.0)
78.9
(54.0 to 115.3)
H3N1, D0 Number Analyzed 775 participants 463 participants 127 participants 77 participants 135 participants 76 participants
15.4
(14.1 to 16.8)
17.1
(15.4 to 19.0)
15.4
(12.4 to 19.1)
11.8
(9.1 to 15.2)
14.8
(12.0 to 18.3)
15.0
(11.7 to 19.2)
H3N1, D21 Number Analyzed 780 participants 465 participants 127 participants 77 participants 135 participants 76 participants
141.0
(130.1 to 152.9)
102.9
(92.2 to 114.8)
187.0
(152.0 to 229.9)
99.7
(74.7 to 133.1)
178.2
(145.9 to 217.7)
93.0
(67.1 to 128.9)
BRI, D0 Number Analyzed 774 participants 466 participants 126 participants 77 participants 135 participants 76 participants
21.6
(19.7 to 23.7)
42.8
(38.4 to 47.7)
23.9
(19.1 to 29.9)
41.3
(31.6 to 53.8)
21.6
(17.7 to 26.5)
38.9
(30.3 to 50.0)
BRI, D21 Number Analyzed 780 participants 466 participants 127 participants 77 participants 135 participants 75 participants
204.8
(190.5 to 220.2)
140.1
(128.1 to 153.1)
164.4
(137.0 to 197.4)
99.3
(80.7 to 122.0)
73.3
(59.2 to 90.7)
69.3
(55.1 to 87.3)
FLO, D0 Number Analyzed 775 participants 466 participants 127 participants 77 participants 135 participants 76 participants
70.5
(64.3 to 77.2)
86.7
(78.6 to 95.6)
66.4
(54.0 to 81.7)
70.8
(57.2 to 87.7)
64.3
(52.5 to 81.3)
80.0
(63.7 to 100.4)
FLO, D21 Number Analyzed 780 participants 466 participants 127 participants 77 participants 135 participants 76 participants
493.1
(459.3 to 529.3)
281.4
(259.6 to 304.9)
211.4
(175.0 to 255.3)
131.9
(109.2 to 159.1)
413.7
(351.2 to 487.2)
180.2
(144.3 to 224.9)
15.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Hide Description Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains.
Time Frame At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.
Arm/Group Title GSK2282512A Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 257 37 42
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
H1N1, D0 Number Analyzed 257 participants 37 participants 42 participants
16.4
(13.9 to 19.2)
20.4
(12.5 to 33.2)
13.7
(9.3 to 20.1)
H1N1, D21 Number Analyzed 257 participants 37 participants 42 participants
173.5
(146.8 to 205.0)
211.9
(132.4 to 339.0)
126.0
(77.0 to 206.3)
H1N1, D180 Number Analyzed 257 participants 37 participants 42 participants
51.7
(43.9 to 61.1)
74.2
(48.0 to 114.7)
45.3
(28.9 to 71.0)
H3N1, D0 Number Analyzed 257 participants 37 participants 42 participants
16.7
(14.4 to 19.4)
14.4
(9.8 to 21.2)
14.6
(10.2 to 20.8)
H3N1, D21 Number Analyzed 256 participants 37 participants 42 participants
121.4
(105.1 to 140.2)
166.0
(108.9 to 253.2)
166.7
(119.2 to 233.3)
H3N1, D180 Number Analyzed 257 participants 37 participants 42 participants
42.1
(37.1 to 47.9)
46.4
(33.9 to 63.7)
61.9
(44.0 to 87.1)
BRI, D0 Number Analyzed 257 participants 37 participants 42 participants
31.1
(26.8 to 36.2)
36.8
(24.8 to 54.5)
23.8
(16.7 to 33.9)
BRI, D21 Number Analyzed 257 participants 37 participants 42 participants
179.0
(158.4 to 202.2)
137.7
(106.0 to 179.0)
62.9
(43.6 to 90.8)
BRI, D180 Number Analyzed 257 participants 37 participants 42 participants
120.1
(106.8 to 134.9)
114.2
(92.9 to 140.4)
68.4
(49.4 to 94.6)
FLO, D0 Number Analyzed 257 participants 37 participants 42 participants
77.3
(66.5 to 89.9)
92.9
(64.6 to 133.7)
68.4
(47.4 to 98.7)
FLO, D21 Number Analyzed 257 participants 37 participants 42 participants
399.2
(355.8 to 447.9)
194.8
(153.5 to 247.2)
275.8
(194.1 to 392.0)
FLO, D180 Number Analyzed 257 participants 37 participants 42 participants
253.1
(226.4 to 282.9)
167.8
(129.2 to 217.8)
239.6
(171.6 to 334.1)
16.Secondary Outcome
Title Number of Seroconverted Subjects Against 4 Strains of Influenza
Hide Description 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 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.
Time Frame At Day 21 (D21) after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 1241 204 211
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1, D21 Number Analyzed 1238 participants 204 participants 211 participants
922
  74.5%
136
  66.7%
138
  65.4%
H3N1, D21 Number Analyzed 1237 participants 204 participants 211 participants
823
  66.5%
149
  73.0%
149
  70.6%
BRI, D21 Number Analyzed 1240 participants 203 participants 210 participants
685
  55.2%
99
  48.8%
62
  29.5%
FLO, D21 Number Analyzed 1241 participants 204 participants 211 participants
680
  54.8%
68
  33.3%
107
  50.7%
17.Secondary Outcome
Title Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata
Hide Description 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 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.
Time Frame At Day 21 (D21) after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A 18-60Y Group GSK2282512A ≥ 61Y Group Victoria Strain FluLaval 18-60Y Group Victoria Strain FluLaval ≥ 61Y Group Yamagata Strain FluLaval 18-60Y Group Yamagata Strain FluLaval ≥ 61Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 775 466 127 77 135 76
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1, D21 Number Analyzed 775 participants 463 participants 127 participants 77 participants 135 participants 75 participants
616
  79.5%
306
  66.1%
96
  75.6%
40
  51.9%
97
  71.9%
41
  54.7%
H3N1, D21 Number Analyzed 775 participants 462 participants 127 participants 77 participants 135 participants 76 participants
544
  70.2%
279
  60.4%
99
  78.0%
50
  64.9%
104
  77.0%
45
  59.2%
BRI, D21 Number Analyzed 774 participants 466 participants 126 participants 77 participants 135 participants 75 participants
522
  67.4%
163
  35.0%
76
  60.3%
23
  29.9%
51
  37.8%
11
  14.7%
FLO, D21 Number Analyzed 775 participants 466 participants 127 participants 77 participants 135 participants 76 participants
500
  64.5%
180
  38.6%
53
  41.7%
15
  19.5%
88
  65.2%
19
  25.0%
18.Secondary Outcome
Title Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
Hide Description 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 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.
Time Frame At Day 21 (D21) post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A 18-60Y Group GSK2282512A ≥ 61Y Group Victoria Strain FluLaval 18-60Y Group Victoria Strain FluLaval ≥ 61Y Group Yamagata Strain FluLaval 18-60Y Group Yamagata Strain FluLaval ≥ 61Y Group
Hide Arm/Group Description:
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 775 466 127 77 135 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
SCF - H1N1, D21 Number Analyzed 775 participants 463 participants 127 participants 77 participants 135 participants 75 participants
15.8
(14.1 to 17.7)
7.7
(6.8 to 8.7)
12.0
(9.2 to 15.6)
6.0
(4.3 to 8.5)
11.0
(8.6 to 14.1)
6.2
(4.3 to 9.0)
SCF - H3N1, D21 Number Analyzed 775 participants 462 participants 127 participants 77 participants 135 participants 76 participants
9.1
(8.3 to 10.1)
6.0
(5.4 to 6.8)
12.2
(9.3 to 15.8)
8.5
(6.1 to 11.8)
12.0
(9.2 to 15.6)
6.2
(4.5 to 8.6)
SCF - BRI, D21 Number Analyzed 774 participants 466 participants 126 participants 77 participants 135 participants 75 participants
9.5
(8.5 to 10.5)
3.3
(2.9 to 3.6)
6.8
(5.3 to 8.7)
2.4
(1.9 to 3.0)
3.4
(2.8 to 4.1)
1.8
(1.4 to 2.3)
SCF - FLO, D21 Number Analyzed 775 participants 466 participants 127 participants 77 participants 135 participants 76 participants
7.0
(6.3 to 7.7)
3.2
(3.0 to 3.6)
3.2
(2.6 to 3.8)
1.9
(1.5 to 2.3)
6.3
(5.0 to 8.0)
2.3
(1.8 to 2.8)
19.Secondary Outcome
Title Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Hide Description 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 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.
Time Frame At Day 21 (D21) post vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2282512A Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 1241 204 211
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
SCF - H1N1, D21 Number Analyzed 1238 participants 204 participants 210 participants
12.1
(11.1 to 13.2)
9.2
(7.5 to 11.4)
9.0
(7.3 to 11.1)
SCF - H3N1, D21 Number Analyzed 1237 participants 204 participants 211 participants
7.8
(7.2 to 8.5)
10.6
(8.6 to 13.0)
9.5
(7.7 to 11.6)
SCF - BRI, D21 Number Analyzed 1240 participants 203 participants 210 participants
6.3
(5.8 to 6.9)
4.6
(3.8 to 5.5)
2.7
(2.3 to 3.2)
SCF - FLO, D21 Number Analyzed 1241 participants 204 participants 211 participants
5.2
(4.9 to 5.6)
2.6
(2.3 to 3.0)
4.4
(3.6 to 5.2)
20.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling at the injection site. Grade 3 pain = significant pain at rest/pain that prevented normal everyday activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame Within the 7-day (Days 0-6) follow-up period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 417 421 422 208 216
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
260
  62.4%
245
  58.2%
245
  58.1%
93
  44.7%
89
  41.2%
Grade 3 Pain
9
   2.2%
5
   1.2%
8
   1.9%
2
   1.0%
3
   1.4%
Any Redness
8
   1.9%
11
   2.6%
3
   0.7%
6
   2.9%
3
   1.4%
Grade 3 Redness
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling
10
   2.4%
13
   3.1%
9
   2.1%
3
   1.4%
8
   3.7%
Grade 3 Swelling
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr. Symptoms), headache, muscle ache, shivering, temperature - oral temperature equal to or above (≥) 38.0 degrees Celsius (°C) - and joint pain at location other than the injection site (Joint Pain). Grade 3 temperature = temperature ≥ 39.0 °C. Grade 3 symptom = symptom that prevented normal everyday activity. Related symptom = symptom assessed by the investigator as causally related to study vaccination. Joint pain data were collected for subjects in Canada and Mexico only.
Time Frame Within the 7-day (Days 0-6) follow-up period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 417 421 422 208 216
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
92
  22.1%
86
  20.4%
93
  22.0%
45
  21.6%
37
  17.1%
Grade 3 Fatigue Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
6
   1.4%
2
   0.5%
2
   0.5%
2
   1.0%
4
   1.9%
Related Fatigue Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
70
  16.8%
72
  17.1%
78
  18.5%
28
  13.5%
32
  14.8%
Any Headache Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
93
  22.3%
87
  20.7%
91
  21.6%
41
  19.7%
49
  22.7%
Grade 3 Headache Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
4
   1.0%
3
   0.7%
4
   0.9%
1
   0.5%
0
   0.0%
Related Headache Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
66
  15.8%
60
  14.3%
72
  17.1%
28
  13.5%
35
  16.2%
Any Muscle Ache Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
113
  27.1%
105
  24.9%
113
  26.8%
52
  25.0%
40
  18.5%
Grade 3 Muscle Ache Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
2
   0.5%
4
   1.0%
4
   0.9%
1
   0.5%
3
   1.4%
Related Muscle Ache Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
93
  22.3%
94
  22.3%
98
  23.2%
39
  18.8%
35
  16.2%
Any Shivering Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
39
   9.4%
37
   8.8%
35
   8.3%
16
   7.7%
13
   6.0%
Grade 3 Shivering Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
4
   1.0%
2
   0.5%
2
   0.5%
1
   0.5%
2
   0.9%
Related Shivering Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
30
   7.2%
30
   7.1%
27
   6.4%
11
   5.3%
8
   3.7%
Any Temperature Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
3
   0.7%
8
   1.9%
8
   1.9%
1
   0.5%
3
   1.4%
Grade 3 Temperature Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
0
   0.0%
3
   0.7%
2
   0.5%
0
   0.0%
1
   0.5%
Related Temperature Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
1
   0.2%
8
   1.9%
6
   1.4%
0
   0.0%
2
   0.9%
Any Joint Pain Number Analyzed 196 participants 199 participants 201 participants 102 participants 103 participants
27
  13.8%
27
  13.6%
34
  16.9%
17
  16.7%
15
  14.6%
Grade 3 Joint Pain Number Analyzed 196 participants 199 participants 201 participants 102 participants 103 participants
1
   0.5%
3
   1.5%
1
   0.5%
1
   1.0%
3
   2.9%
Related Joint Pain Number Analyzed 196 participants 199 participants 201 participants 102 participants 103 participants
17
   8.7%
20
  10.1%
21
  10.4%
10
   9.8%
11
  10.7%
Any Gastr. Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
43
  10.3%
35
   8.3%
39
   9.2%
21
  10.1%
16
   7.4%
Grade 3 Gastr. Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
5
   1.2%
1
   0.2%
4
   0.9%
4
   1.9%
1
   0.5%
Related Gastr. Number Analyzed 417 participants 421 participants 422 participants 208 participants 216 participants
34
   8.2%
26
   6.2%
23
   5.5%
11
   5.3%
8
   3.7%
22.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination.
Time Frame Within the 21-day (Days 0-20) follow-up period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 423 424 425 213 218
Measure Type: Count of Participants
Unit of Measure: Participants
Subject(s) with Any Unsolicited AE(s)
77
  18.2%
80
  18.9%
87
  20.5%
48
  22.5%
51
  23.4%
Subject(s) with Grade 3 Unsolicited AE(s)
5
   1.2%
5
   1.2%
15
   3.5%
6
   2.8%
7
   3.2%
Subject(s) with Related Unsolicited AE(s)
18
   4.3%
26
   6.1%
21
   4.9%
11
   5.2%
13
   6.0%
23.Secondary Outcome
Title Number of Days With Solicited Local Symptoms After Vaccination.
Hide Description Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed.
Time Frame Within the 7-day follow-up period after vaccination (Days 0-6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title Number of Days With Solicited General Symptoms After Vaccination
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr.), headache, muscle ache, shivering, temperature (defined as oral temperature equal to or above 38.0 degrees Celsius) and joint pain at location other than the injection site (Joint Pain). Joint pain data were collected for subjects in Canada and Mexico only. Analyses of duration for solicited general symptoms were not performed.
Time Frame Within the 7-day follow-up period after vaccination (Days 0-6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Number of Days With Unsolicited Adverse Events (AEs) After Vaccination
Hide Description Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity. Analyses of duration for unsolicited AEs were not performed.
Time Frame Within the 21-day (Days 0-20) follow-up period post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Yamagata Strain FluLaval Group
Hide Arm/Group Description:
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Reports of solicited local and general adverse events were collected during the 7-day (Days 0-6) follow-up period following vaccination. Reports for serious adverse events were collected throughout the study, from Day 0 to Day 180.
Adverse Event Reporting Description Other Adverse Events were collected only from participants who completed their symptoms sheet.
 
Arm/Group Title GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Hide Arm/Group Description Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.dominant arm. Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
All-Cause Mortality
GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/423 (3.55%)   13/424 (3.07%)   7/425 (1.65%)   3/213 (1.41%)   7/218 (3.21%) 
Cardiac disorders           
Angina unstable * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  1/213 (0.47%)  0/218 (0.00%) 
Cardiac failure * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Cardiac failure congestive * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Cardiogenic shock * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Cardiopulmonary failure * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Coronary artery disease * 1  0/423 (0.00%)  0/424 (0.00%)  1/425 (0.24%)  0/213 (0.00%)  1/218 (0.46%) 
Mitral valve incompetence * 1  0/423 (0.00%)  0/424 (0.00%)  1/425 (0.24%)  0/213 (0.00%)  0/218 (0.00%) 
Myocardial infarction * 1  1/423 (0.24%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Myocardial ischaemia * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Nodal rhythm * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Gastrointestinal disorders           
Dyspepsia * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Dysphagia * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Gastrointestinal mucosal disorder * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  1/213 (0.47%)  0/218 (0.00%) 
Pancreatitis acute * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Upper gastrointestinal haemorrhage * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  1/213 (0.47%)  0/218 (0.00%) 
General disorders           
Gait disturbance * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Pain * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Hepatobiliary disorders           
Cholecystitis * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Cholecystitis acute * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Cholecystitis chronic * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Hepatic cirrhosis * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  1/218 (0.46%) 
Portal hypertension * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  1/218 (0.46%) 
Infections and infestations           
Abscess limb * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  1/218 (0.46%) 
Bronchitis * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  1/218 (0.46%) 
Diverticulitis * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Pneumonia * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Urinary tract infection * 1  0/423 (0.00%)  1/424 (0.24%)  1/425 (0.24%)  0/213 (0.00%)  0/218 (0.00%) 
Injury, poisoning and procedural complications           
Anaemia postoperative * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Animal bite * 1  0/423 (0.00%)  0/424 (0.00%)  1/425 (0.24%)  0/213 (0.00%)  0/218 (0.00%) 
Ankle fracture * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Fracture displacement * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  1/213 (0.47%)  0/218 (0.00%) 
Hip fracture * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  1/213 (0.47%)  1/218 (0.46%) 
Humerus fracture * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Multiple injuries * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  1/218 (0.46%) 
Patella fracture * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Stab wound * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Musculoskeletal and connective tissue disorders           
Cervical spinal stenosis * 1  0/423 (0.00%)  0/424 (0.00%)  1/425 (0.24%)  0/213 (0.00%)  0/218 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Malignant melanoma * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Metastatic neoplasm * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Non-small cell lung cancer * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Parathyroid tumour benign * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Prostate cancer * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  1/218 (0.46%) 
Rectal cancer * 1  0/423 (0.00%)  0/424 (0.00%)  1/425 (0.24%)  0/213 (0.00%)  0/218 (0.00%) 
Nervous system disorders           
Cerebrovascular accident * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Cerebrovascular disorder * 1  1/423 (0.24%)  0/424 (0.00%)  1/425 (0.24%)  0/213 (0.00%)  0/218 (0.00%) 
Hypoaesthesia * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  1/213 (0.47%)  0/218 (0.00%) 
Ischaemic stroke * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Renal and urinary disorders           
Calculus bladder * 1  0/423 (0.00%)  0/424 (0.00%)  1/425 (0.24%)  0/213 (0.00%)  0/218 (0.00%) 
Renal failure chronic * 1  1/423 (0.24%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Reproductive system and breast disorders           
Cystocele * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthmatic crisis * 1  0/423 (0.00%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  1/218 (0.46%) 
Dyspnoea * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Pulmonary embolism * 1  1/423 (0.24%)  0/424 (0.00%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Sleep apnoea syndrome * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Vascular disorders           
Arteriosclerosis * 1  0/423 (0.00%)  1/424 (0.24%)  0/425 (0.00%)  0/213 (0.00%)  0/218 (0.00%) 
Venous thrombosis limb * 1  0/423 (0.00%)  0/424 (0.00%)  1/425 (0.24%)  0/213 (0.00%)  0/218 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK2282512A 1 Group GSK2282512A 2 Group GSK2282512A 3 Group Victoria Strain FluLaval Group Yamagata Strain FluLaval Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   294/417 (70.50%)   286/421 (67.93%)   284/422 (67.30%)   127/208 (61.06%)   113/216 (52.31%) 
General disorders           
Pain  1  260/417 (62.35%)  245/421 (58.19%)  245/422 (58.06%)  93/208 (44.71%)  89/216 (41.20%) 
Fatigue  1  92/417 (22.06%)  86/421 (20.43%)  93/422 (22.04%)  45/208 (21.63%)  37/216 (17.13%) 
Gastrointestinal adverse event(s)  1  43/417 (10.31%)  35/421 (8.31%)  39/422 (9.24%)  21/208 (10.10%)  15/216 (6.94%) 
Headache  1  93/417 (22.30%)  87/421 (20.67%)  91/422 (21.56%)  41/208 (19.71%)  49/216 (22.69%) 
Muscle aches  1  113/417 (27.10%)  105/421 (24.94%)  113/422 (26.78%)  52/208 (25.00%)  40/216 (18.52%) 
Shivering  1  39/417 (9.35%)  37/421 (8.79%)  35/422 (8.29%)  16/208 (7.69%)  13/216 (6.02%) 
Joint pain at other location than injection site  1  27/417 (6.47%)  27/421 (6.41%)  34/422 (8.06%)  17/208 (8.17%)  15/216 (6.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Analyses of duration for solicited local and general and unsolicited adverse events were not performed. Relationship to vaccination was not computed for medically-attended adverse events. Joint pain data were collected in Canada and Mexico only.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01196975    
Other Study ID Numbers: 112963
First Submitted: September 7, 2010
First Posted: September 9, 2010
Results First Submitted: November 21, 2012
Results First Posted: December 24, 2012
Last Update Posted: September 21, 2018