Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults (NCT NCT01196975)

NCT ID: NCT01196975

Last Updated: 2018-09-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1707 participants
• Primary outcome timeframe: At Day 0 (D0) and at Day 21 (D21) post vaccination.
• Results posted on: 2018-09-21

Participant Flow

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.

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).

Participant milestones

Measure	GSK2282512A 1 Group 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.	GSK2282512A 2 Group 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.	GSK2282512A 3 Group 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.	Victoria Strain FluLaval Group 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 Study STARTED	423	424	425	213	218
Overall Study COMPLETED	408	415	420	207	205
Overall Study NOT COMPLETED	15	9	5	6	13

Reasons for withdrawal

Measure	GSK2282512A 1 Group 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.	GSK2282512A 2 Group 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.	GSK2282512A 3 Group 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.	Victoria Strain FluLaval Group 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 Study Adverse Event	2	2	0	0	2
Overall Study Withdrawal by Subject	2	1	0	1	0
Overall Study Lost to Follow-up	11	6	5	5	11

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	GSK2282512A 1 Group n=423 Participants 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	GSK2282512A 2 Group n=424 Participants 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.	GSK2282512A 3 Group n=425 Participants 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.	Victoria Strain FluLaval Group n=213 Participants 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 n=218 Participants 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 n=1703 Participants Total of all reporting groups
Age, Continuous	49.9 Years STANDARD_DEVIATION 19.49 • n=5 Participants	50.4 Years STANDARD_DEVIATION 19.07 • n=7 Participants	49.8 Years STANDARD_DEVIATION 20.10 • n=5 Participants	50.8 Years STANDARD_DEVIATION 18.58 • n=4 Participants	49.6 Years STANDARD_DEVIATION 19.34 • n=21 Participants	50.1 Years STANDARD_DEVIATION 19.32 • n=8 Participants
Sex: Female, Male Female	251 Participants n=5 Participants	264 Participants n=7 Participants	266 Participants n=5 Participants	125 Participants n=4 Participants	138 Participants n=21 Participants	1044 Participants n=8 Participants
Sex: Female, Male Male	172 Participants n=5 Participants	160 Participants n=7 Participants	159 Participants n=5 Participants	88 Participants n=4 Participants	80 Participants n=21 Participants	659 Participants n=8 Participants

PRIMARY outcome

Timeframe: At Day 0 (D0) and at Day 21 (D21) post vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=1246 Participants 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.	Victoria Strain FluLaval Group n=204 Participants 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 n=211 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group 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.	Yamagata Strain FluLaval 18-64Y Group 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H1N1, D0	16.9 Titer Interval 15.7 to 18.2	19.1 Titer Interval 15.8 to 23.1	16.5 Titer Interval 13.9 to 19.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H1N1, D21	204.6 Titer Interval 190.4 to 219.9	176.0 Titer Interval 149.1 to 207.7	149.0 Titer Interval 122.9 to 180.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H3N1, D0	16.0 Titer Interval 15.0 to 17.1	13.9 Titer Interval 11.8 to 16.4	14.9 Titer Interval 12.7 to 17.5	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H3N1, D21	125.4 Titer Interval 117.4 to 133.9	147.5 Titer Interval 124.1 to 175.2	141.0 Titer Interval 118.1 to 168.3	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease BRI, D0	27.9 Titer Interval 26.0 to 30.0	29.4 Titer Interval 24.7 to 35.0	26.7 Titer Interval 22.8 to 31.4	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease BRI, D21	177.7 Titer Interval 167.8 to 188.1	135.9 Titer Interval 118.1 to 156.5	71.9 Titer Interval 61.3 to 84.2	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease FLO, D0	76.2 Titer Interval 71.1 to 81.5	68.1 Titer Interval 58.5 to 79.2	70.3 Titer Interval 59.8 to 82.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease FLO, D21	399.7 Titer Interval 378.1 to 422.6	176.9 Titer Interval 153.8 to 203.5	306.6 Titer Interval 266.2 to 353.3	—	—	—

SECONDARY outcome

Timeframe: At Day 0 (D0) and at Day 21 (D21) post vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=849 Participants 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.	Victoria Strain FluLaval Group n=397 Participants 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 n=136 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=68 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=144 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=68 Participants 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.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D0	19.0 titer Interval 17.4 to 20.9	13.2 titer Interval 11.7 to 14.7	20.3 titer Interval 16.0 to 25.8	16.8 titer Interval 12.3 to 22.9	18.7 titer Interval 15.0 to 23.2	12.6 titer Interval 9.6 to 16.5
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D21	289.4 titer Interval 267.9 to 312.7	97.4 titer Interval 85.9 to 110.5	236.9 titer Interval 199.7 to 281.1	97.1 titer Interval 70.3 to 134.1	198.5 titer Interval 161.7 to 243.7	80.8 titer Interval 55.1 to 118.5
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D0	15.2 titer Interval 14.0 to 16.6	17.8 titer Interval 15.9 to 19.9	15.0 titer Interval 12.1 to 18.4	12.0 titer Interval 9.1 to 15.8	14.8 titer Interval 12.1 to 18.1	15.1 titer Interval 11.6 to 19.7
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D21	136.1 titer Interval 125.9 to 147.2	105.1 titer Interval 93.4 to 118.3	176.3 titer Interval 144.3 to 215.4	103.2 titer Interval 75.1 to 141.8	173.6 titer Interval 142.5 to 211.6	90.1 titer Interval 63.8 to 127.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D0	21.7 titer Interval 19.9 to 23.7	47.9 titer Interval 42.8 to 53.5	23.8 titer Interval 19.1 to 29.6	44.7 titer Interval 34.1 to 58.6	22.8 titer Interval 18.7 to 27.8	37.6 titer Interval 28.8 to 49.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D21	199.3 titer Interval 185.9 to 213.6	139.0 titer Interval 126.2 to 153.1	157.2 titer Interval 131.5 to 187.9	101.6 titer Interval 81.8 to 126.1	75.1 titer Interval 61.2 to 92.2	65.4 titer Interval 51.3 to 83.4
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D0	70.7 titer Interval 64.8 to 77.2	89.1 titer Interval 80.2 to 98.9	66.1 titer Interval 54.3 to 80.4	72.2 titer Interval 57.2 to 91.2	67.6 titer Interval 54.8 to 83.4	76.3 titer Interval 59.9 to 97.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D21	475.3 titer Interval 444.2 to 508.5	276.1 titer Interval 252.8 to 301.5	204.9 titer Interval 171.3 to 245.0	131.8 titer Interval 107.1 to 162.3	406.1 titer Interval 347.3 to 474.9	167.7 titer Interval 132.0 to 212.9

SECONDARY outcome

Timeframe: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=122 Participants 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.	Victoria Strain FluLaval Group n=135 Participants 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 n=17 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=20 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=22 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=20 Participants 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.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D0	23.1 titer Interval 17.9 to 29.8	12.0 titer Interval 9.9 to 14.5	22.6 titer Interval 11.6 to 44.0	18.7 titer Interval 8.7 to 39.9	17.9 titer Interval 10.0 to 32.1	10.2 titer Interval 6.1 to 17.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D21	302.4 titer Interval 245.8 to 372.0	105.0 titer Interval 83.6 to 131.9	369.1 titer Interval 216.2 to 630.0	132.2 titer Interval 64.5 to 270.7	187.4 titer Interval 110.4 to 318.2	81.4 titer Interval 34.2 to 194.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D180	97.9 titer Interval 80.3 to 119.3	29.1 titer Interval 23.4 to 36.2	104.2 titer Interval 57.0 to 190.5	55.6 titer Interval 29.3 to 105.6	57.5 titer Interval 33.2 to 99.4	34.8 titer Interval 16.2 to 74.8
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D0	15.5 titer Interval 12.3 to 19.4	17.9 titer Interval 14.7 to 21.8	12.0 titer Interval 7.3 to 19.7	16.8 titer Interval 9.1 to 30.9	12.7 titer Interval 7.7 to 20.7	17.1 titer Interval 9.9 to 29.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D21	123.2 titer Interval 100.4 to 151.2	119.8 titer Interval 97.6 to 147.0	163.3 titer Interval 103.0 to 258.8	168.4 titer Interval 82.1 to 345.6	175.9 titer Interval 110.7 to 279.3	157.2 titer Interval 92.3 to 267.9
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D180	40.9 titer Interval 33.5 to 49.9	43.3 titer Interval 36.7 to 51.1	46.1 titer Interval 31.8 to 67.0	46.7 titer Interval 27.6 to 79.0	63.0 titer Interval 39.5 to 100.8	60.6 titer Interval 35.1 to 104.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D0	22.9 titer Interval 18.3 to 28.6	41.1 titer Interval 33.9 to 49.8	30.7 titer Interval 16.1 to 58.6	42.9 titer Interval 25.4 to 72.3	17.9 titer Interval 11.7 to 27.3	32.5 titer Interval 18.0 to 58.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D21	193.0 titer Interval 161.0 to 231.4	167.2 titer Interval 141.6 to 197.3	180.9 titer Interval 120.9 to 270.7	109.3 titer Interval 77.7 to 153.6	53.9 titer Interval 31.0 to 93.6	74.7 titer Interval 44.7 to 124.9
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D180	112.8 titer Interval 94.1 to 135.3	127.0 titer Interval 109.1 to 147.8	130.5 titer Interval 91.8 to 185.4	102.0 titer Interval 78.8 to 132.0	59.3 titer Interval 36.9 to 95.4	79.9 titer Interval 49.8 to 128.5
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D0	75.4 titer Interval 59.3 to 95.8	79.2 titer Interval 65.5 to 95.7	92.3 titer Interval 54.5 to 156.4	93.5 titer Interval 54.0 to 161.7	60.3 titer Interval 38.7 to 93.9	78.6 titer Interval 41.6 to 148.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D21	485.8 titer Interval 407.3 to 579.5	334.3 titer Interval 288.9 to 386.8	204.4 titer Interval 134.8 to 310.0	187.0 titer Interval 138.5 to 252.3	405.3 titer Interval 273.8 to 600.0	180.6 titer Interval 101.4 to 321.7
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D180	311.9 titer Interval 261.7 to 371.7	209.5 titer Interval 183.0 to 239.8	177.3 titer Interval 120.5 to 260.9	160.1 titer Interval 108.8 to 235.6	320.1 titer Interval 207.8 to 492.9	174.3 titer Interval 104.3 to 291.2

SECONDARY outcome

Timeframe: From the beginning of the study until study end (from Day 0 to Day 180)

Population: The analysis was performed on the Total Vaccinated cohort, on subjects with available results.

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.

Outcome measures

Measure	GSK2282512A Group n=423 Participants 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.	Victoria Strain FluLaval Group n=424 Participants 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 n=425 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=213 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=218 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Number of Subjects With Medically-attended Adverse Events (MAEs)	129 Participants	101 Participants	100 Participants	51 Participants	64 Participants	—

SECONDARY outcome

Timeframe: From the beginning of the study until study end (from Day 0 to Day 180) .

Population: The analysis was performed on the Total Vaccinated cohort, on subjects with available results.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the beginning of the study until study end (from Day 0 to Day 180) .

Population: The analysis was performed on the Total Vaccinated cohort, on subjects with available results.

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.

Outcome measures

Measure	GSK2282512A Group n=423 Participants 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.	Victoria Strain FluLaval Group n=424 Participants 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 n=425 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=213 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=218 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) Subject(s) with Any pIMD(s)	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) Subject(s) with Related pIMD(s)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From the beginning of the study until study end (from Day 0 to Day 180)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

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.

Outcome measures

Measure	GSK2282512A Group n=423 Participants 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.	Victoria Strain FluLaval Group n=424 Participants 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 n=425 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=213 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=218 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Subject(s) with Any SAE(s)	15 Participants	13 Participants	7 Participants	3 Participants	7 Participants	—
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Subject(s) with Related SAE(s)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=131 Participants 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.	Victoria Strain FluLaval Group n=126 Participants 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 n=18 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=19 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=23 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=19 Participants 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.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D0	22.7 Titer Interval 17.8 to 29.0	11.6 Titer Interval 9.6 to 14.2	23.3 Titer Interval 12.4 to 43.7	17.9 Titer Interval 8.1 to 39.8	18.0 Titer Interval 10.3 to 31.4	9.8 Titer Interval 5.7 to 16.8
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D21	293.3 Titer Interval 240.7 to 357.3	100.5 Titer Interval 79.1 to 127.7	339.0 Titer Interval 199.0 to 577.6	135.7 Titer Interval 63.7 to 289.2	180.6 Titer Interval 108.4 to 300.8	81.5 Titer Interval 32.5 to 204.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D180	95.5 Titer Interval 79.1 to 115.3	27.4 Titer Interval 21.8 to 34.4	98.8 Titer Interval 55.5 to 176.0	56.6 Titer Interval 28.7 to 111.4	56.6 Titer Interval 33.5 to 95.4	34.5 Titer Interval 15.4 to 77.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D0	15.3 Titer Interval 12.2 to 19.1	18.4 Titer Interval 15.1 to 22.3	13.3 Titer Interval 8.0 to 22.4	15.5 Titer Interval 8.3 to 28.8	12.2 Titer Interval 7.5 to 19.6	18.2 Titer Interval 10.4 to 32.2
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D21	115.0 Titer Interval 93.2 to 141.9	128.6 Titer Interval 105.4 to 156.8	163.1 Titer Interval 105.8 to 251.3	168.9 Titer Interval 79.0 to 361.3	175.1 Titer Interval 112.7 to 272.2	157.1 Titer Interval 89.4 to 276.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D180	41.3 Titer Interval 34.0 to 50.0	43.1 Titer Interval 36.3 to 51.0	49.4 Titer Interval 33.8 to 72.2	43.8 Titer Interval 25.6 to 74.9	61.9 Titer Interval 39.5 to 96.9	61.9 Titer Interval 34.8 to 110.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D0	23.1 Titer Interval 18.6 to 28.6	42.5 Titer Interval 34.8 to 51.8	29.9 Titer Interval 16.3 to 55.1	44.6 Titer Interval 25.9 to 77.0	19.7 Titer Interval 12.6 to 30.8	29.9 Titer Interval 16.5 to 54.2
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D21	183.6 Titer Interval 154.3 to 218.6	174.3 Titer Interval 146.6 to 207.1	166.4 Titer Interval 109.6 to 252.5	115.2 Titer Interval 81.9 to 162.0	56.5 Titer Interval 33.1 to 96.5	71.8 Titer Interval 41.9 to 122.8
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D180	111.1 Titer Interval 93.6 to 131.8	130.2 Titer Interval 111.0 to 152.7	124.6 Titer Interval 88.4 to 175.7	105.2 Titer Interval 80.8 to 137.0	63.8 Titer Interval 39.6 to 102.9	74.3 Titer Interval 46.2 to 119.5
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D0	78.5 Titer Interval 62.4 to 98.8	76.1 Titer Interval 62.6 to 92.6	98.9 Titer Interval 59.1 to 165.6	87.6 Titer Interval 50.0 to 153.7	64.8 Titer Interval 41.4 to 101.5	73.0 Titer Interval 38.0 to 140.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D21	473.4 Titer Interval 399.7 to 560.6	334.4 Titer Interval 287.4 to 389.1	209.5 Titer Interval 141.3 to 310.8	181.7 Titer Interval 133.2 to 248.0	401.2 Titer Interval 275.9 to 583.3	175.3 Titer Interval 95.5 to 321.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D180	314.1 Titer Interval 266.4 to 370.4	202.1 Titer Interval 175.6 to 232.7	190.4 Titer Interval 128.6 to 281.9	148.8 Titer Interval 102.3 to 216.6	329.9 Titer Interval 217.6 to 500.1	162.8 Titer Interval 96.6 to 274.2

SECONDARY outcome

Timeframe: At Day 0 (D0) and at Day 21 (D21) after vaccination.

Population: 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.

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

Outcome measures

Measure	GSK2282512A Group n=1246 Participants 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.	Victoria Strain FluLaval Group n=204 Participants 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 n=211 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group 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.	Yamagata Strain FluLaval 18-64Y Group 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease H1N1, D0	423 Participants	78 Participants	63 Participants	—	—	—
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease H1N1, D21	1168 Participants	189 Participants	182 Participants	—	—	—
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease H3N1, D0	385 Participants	55 Participants	64 Participants	—	—	—
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease H3N1, D21	1130 Participants	188 Participants	193 Participants	—	—	—
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease BRI, D0	635 Participants	103 Participants	98 Participants	—	—	—
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease BRI, D21	1201 Participants	193 Participants	167 Participants	—	—	—
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease FLO, D0	997 Participants	162 Participants	168 Participants	—	—	—
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease FLO, D21	1244 Participants	200 Participants	207 Participants	—	—	—

SECONDARY outcome

Timeframe: At Day 0 (D0) and at Day 21 (D21) after vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=780 Participants 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.	Victoria Strain FluLaval Group n=466 Participants 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 n=127 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=77 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=135 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=76 Participants 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.
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata H1N1, D0	309 Participants	114 Participants	51 Participants	27 Participants	50 Participants	13 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata H1N1, D21	765 Participants	403 Participants	125 Participants	64 Participants	127 Participants	55 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata H3N1, D0	229 Participants	156 Participants	38 Participants	17 Participants	40 Participants	24 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata H3N1, D21	726 Participants	404 Participants	122 Participants	66 Participants	130 Participants	63 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata BRI, D0	338 Participants	297 Participants	52 Participants	51 Participants	53 Participants	45 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata BRI, D21	760 Participants	441 Participants	121 Participants	72 Participants	107 Participants	60 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata FLO, D0	591 Participants	406 Participants	99 Participants	63 Participants	105 Participants	63 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata FLO, D21	779 Participants	465 Participants	125 Participants	75 Participants	134 Participants	73 Participants

SECONDARY outcome

Timeframe: At Day 0 (D0) and at Day 21 (D21) after vaccination

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=849 Participants 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.	Victoria Strain FluLaval Group n=397 Participants 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 n=136 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=68 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=144 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=67 Participants 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.
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata H1N1, D0	330 Participants	93 Participants	55 Participants	23 Participants	51 Participants	12 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata H1N1, D21	830 Participants	338 Participants	134 Participants	55 Participants	132 Participants	50 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata H3N1, D0	251 Participants	134 Participants	40 Participants	15 Participants	42 Participants	22 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata H3N1, D21	784 Participants	346 Participants	129 Participants	59 Participants	137 Participants	56 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata BRI, D0	366 Participants	269 Participants	55 Participants	48 Participants	59 Participants	39 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata BRI, D21	826 Participants	375 Participants	130 Participants	63 Participants	114 Participants	53 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata FLO, D0	650 Participants	347 Participants	105 Participants	57 Participants	112 Participants	56 Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata FLO, D21	848 Participants	396 Participants	134 Participants	66 Participants	143 Participants	64 Participants

SECONDARY outcome

Timeframe: At Day 21 (D21) after vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=844 Participants 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.	Victoria Strain FluLaval Group n=397 Participants 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 n=136 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=68 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=144 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=67 Participants 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.
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata H3N1, D21	584 Participants	239 Participants	104 Participants	45 Participants	109 Participants	40 Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata BRI, D21	561 Participants	124 Participants	80 Participants	19 Participants	52 Participants	10 Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata H1N1, D21	667 Participants	255 Participants	101 Participants	35 Participants	102 Participants	36 Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata FLO, D21	533 Participants	147 Participants	55 Participants	13 Participants	90 Participants	17 Participants

SECONDARY outcome

Timeframe: At Day 21 (D21) after vaccination

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=844 Participants 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.	Victoria Strain FluLaval Group n=397 Participants 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 n=136 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=68 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=144 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=67 Participants 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.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata SCF - H1N1, D21	15.2 Titer Interval 13.7 to 16.9	7.4 Titer Interval 6.4 to 8.4	11.7 Titer Interval 9.0 to 15.1	5.8 Titer Interval 4.0 to 8.3	10.5 Titer Interval 8.2 to 13.4	6.4 Titer Interval 4.3 to 9.5
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata SCF - H3N1, D21	8.9 Titer Interval 8.1 to 9.8	5.9 Titer Interval 5.2 to 6.7	11.8 Titer Interval 9.2 to 15.1	8.6 Titer Interval 5.9 to 12.4	11.7 Titer Interval 9.1 to 15.1	6.0 Titer Interval 4.3 to 8.3
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata SCF - BRI, D21	9.2 Titer Interval 8.3 to 10.1	2.9 Titer Interval 2.6 to 3.2	6.5 Titer Interval 5.1 to 8.3	2.3 Titer Interval 1.8 to 2.9	3.3 Titer Interval 2.7 to 4.1	1.7 Titer Interval 1.4 to 2.2
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata SCF - FLO, D21	6.7 Titer Interval 6.1 to 7.4	3.1 Titer Interval 2.8 to 3.4	3.1 Titer Interval 2.6 to 3.7	1.8 Titer Interval 1.5 to 2.3	6.0 Titer Interval 4.8 to 7.5	2.2 Titer Interval 1.8 to 2.7

SECONDARY outcome

Timeframe: At Day 0 (D0) and at Day 21 (D21) post vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=780 Participants 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.	Victoria Strain FluLaval Group n=466 Participants 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 n=127 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=77 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=135 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=76 Participants 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.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D0	19.5 titer Interval 17.7 to 21.5	13.4 titer Interval 12.0 to 14.9	20.7 titer Interval 16.1 to 26.6	16.6 titer Interval 12.4 to 22.3	19.3 titer Interval 15.4 to 24.2	12.5 titer Interval 9.7 to 16.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H1N1, D21	306.9 titer Interval 283.3 to 332.5	103.8 titer Interval 92.6 to 116.3	248.3 titer Interval 207.8 to 296.6	99.7 titer Interval 74.7 to 133.2	212.2 titer Interval 175.2 to 257.0	78.9 titer Interval 54.0 to 115.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D0	15.4 titer Interval 14.1 to 16.8	17.1 titer Interval 15.4 to 19.0	15.4 titer Interval 12.4 to 19.1	11.8 titer Interval 9.1 to 15.2	14.8 titer Interval 12.0 to 18.3	15.0 titer Interval 11.7 to 19.2
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata H3N1, D21	141.0 titer Interval 130.1 to 152.9	102.9 titer Interval 92.2 to 114.8	187.0 titer Interval 152.0 to 229.9	99.7 titer Interval 74.7 to 133.1	178.2 titer Interval 145.9 to 217.7	93.0 titer Interval 67.1 to 128.9
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D0	21.6 titer Interval 19.7 to 23.7	42.8 titer Interval 38.4 to 47.7	23.9 titer Interval 19.1 to 29.9	41.3 titer Interval 31.6 to 53.8	21.6 titer Interval 17.7 to 26.5	38.9 titer Interval 30.3 to 50.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata BRI, D21	204.8 titer Interval 190.5 to 220.2	140.1 titer Interval 128.1 to 153.1	164.4 titer Interval 137.0 to 197.4	99.3 titer Interval 80.7 to 122.0	73.3 titer Interval 59.2 to 90.7	69.3 titer Interval 55.1 to 87.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D0	70.5 titer Interval 64.3 to 77.2	86.7 titer Interval 78.6 to 95.6	66.4 titer Interval 54.0 to 81.7	70.8 titer Interval 57.2 to 87.7	64.3 titer Interval 52.5 to 81.3	80.0 titer Interval 63.7 to 100.4
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata FLO, D21	493.1 titer Interval 459.3 to 529.3	281.4 titer Interval 259.6 to 304.9	211.4 titer Interval 175.0 to 255.3	131.9 titer Interval 109.2 to 159.1	413.7 titer Interval 351.2 to 487.2	180.2 titer Interval 144.3 to 224.9

SECONDARY outcome

Timeframe: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=257 Participants 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.	Victoria Strain FluLaval Group n=37 Participants 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 n=42 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group 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.	Yamagata Strain FluLaval 18-64Y Group 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease BRI, D0	31.1 Titer Interval 26.8 to 36.2	36.8 Titer Interval 24.8 to 54.5	23.8 Titer Interval 16.7 to 33.9	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease BRI, D21	179.0 Titer Interval 158.4 to 202.2	137.7 Titer Interval 106.0 to 179.0	62.9 Titer Interval 43.6 to 90.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease BRI, D180	120.1 Titer Interval 106.8 to 134.9	114.2 Titer Interval 92.9 to 140.4	68.4 Titer Interval 49.4 to 94.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease FLO, D0	77.3 Titer Interval 66.5 to 89.9	92.9 Titer Interval 64.6 to 133.7	68.4 Titer Interval 47.4 to 98.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease FLO, D21	399.2 Titer Interval 355.8 to 447.9	194.8 Titer Interval 153.5 to 247.2	275.8 Titer Interval 194.1 to 392.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease FLO, D180	253.1 Titer Interval 226.4 to 282.9	167.8 Titer Interval 129.2 to 217.8	239.6 Titer Interval 171.6 to 334.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H1N1, D0	16.4 Titer Interval 13.9 to 19.2	20.4 Titer Interval 12.5 to 33.2	13.7 Titer Interval 9.3 to 20.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H1N1, D21	173.5 Titer Interval 146.8 to 205.0	211.9 Titer Interval 132.4 to 339.0	126.0 Titer Interval 77.0 to 206.3	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H1N1, D180	51.7 Titer Interval 43.9 to 61.1	74.2 Titer Interval 48.0 to 114.7	45.3 Titer Interval 28.9 to 71.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H3N1, D0	16.7 Titer Interval 14.4 to 19.4	14.4 Titer Interval 9.8 to 21.2	14.6 Titer Interval 10.2 to 20.8	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H3N1, D21	121.4 Titer Interval 105.1 to 140.2	166.0 Titer Interval 108.9 to 253.2	166.7 Titer Interval 119.2 to 233.3	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H3N1, D180	42.1 Titer Interval 37.1 to 47.9	46.4 Titer Interval 33.9 to 63.7	61.9 Titer Interval 44.0 to 87.1	—	—	—

SECONDARY outcome

Timeframe: At Day 21 (D21) after vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=1241 Participants 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.	Victoria Strain FluLaval Group n=204 Participants 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 n=211 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group 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.	Yamagata Strain FluLaval 18-64Y Group 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Number of Seroconverted Subjects Against 4 Strains of Influenza H1N1, D21	922 Participants	136 Participants	138 Participants	—	—	—
Number of Seroconverted Subjects Against 4 Strains of Influenza H3N1, D21	823 Participants	149 Participants	149 Participants	—	—	—
Number of Seroconverted Subjects Against 4 Strains of Influenza BRI, D21	685 Participants	99 Participants	62 Participants	—	—	—
Number of Seroconverted Subjects Against 4 Strains of Influenza FLO, D21	680 Participants	68 Participants	107 Participants	—	—	—

SECONDARY outcome

Timeframe: At Day 21 (D21) after vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=775 Participants 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.	Victoria Strain FluLaval Group n=466 Participants 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 n=127 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=77 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=135 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=76 Participants 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.
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata H1N1, D21	616 Participants	306 Participants	96 Participants	40 Participants	97 Participants	41 Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata H3N1, D21	544 Participants	279 Participants	99 Participants	50 Participants	104 Participants	45 Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata BRI, D21	522 Participants	163 Participants	76 Participants	23 Participants	51 Participants	11 Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata FLO, D21	500 Participants	180 Participants	53 Participants	15 Participants	88 Participants	19 Participants

SECONDARY outcome

Timeframe: At Day 21 (D21) post vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=775 Participants 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.	Victoria Strain FluLaval Group n=466 Participants 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 n=127 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=77 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=135 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group n=76 Participants 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.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata SCF - H1N1, D21	15.8 Titer Interval 14.1 to 17.7	7.7 Titer Interval 6.8 to 8.7	12.0 Titer Interval 9.2 to 15.6	6.0 Titer Interval 4.3 to 8.5	11.0 Titer Interval 8.6 to 14.1	6.2 Titer Interval 4.3 to 9.0
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata SCF - H3N1, D21	9.1 Titer Interval 8.3 to 10.1	6.0 Titer Interval 5.4 to 6.8	12.2 Titer Interval 9.3 to 15.8	8.5 Titer Interval 6.1 to 11.8	12.0 Titer Interval 9.2 to 15.6	6.2 Titer Interval 4.5 to 8.6
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata SCF - FLO, D21	7.0 Titer Interval 6.3 to 7.7	3.2 Titer Interval 3.0 to 3.6	3.2 Titer Interval 2.6 to 3.8	1.9 Titer Interval 1.5 to 2.3	6.3 Titer Interval 5.0 to 8.0	2.3 Titer Interval 1.8 to 2.8
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata SCF - BRI, D21	9.5 Titer Interval 8.5 to 10.5	3.3 Titer Interval 2.9 to 3.6	6.8 Titer Interval 5.3 to 8.7	2.4 Titer Interval 1.9 to 3.0	3.4 Titer Interval 2.8 to 4.1	1.8 Titer Interval 1.4 to 2.3

SECONDARY outcome

Timeframe: At Day 21 (D21) post vaccination.

Population: 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.

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.

Outcome measures

Measure	GSK2282512A Group n=1241 Participants 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.	Victoria Strain FluLaval Group n=204 Participants 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 n=211 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group 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.	Yamagata Strain FluLaval 18-64Y Group 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease SCF - H1N1, D21	12.1 Titer Interval 11.1 to 13.2	9.2 Titer Interval 7.5 to 11.4	9.0 Titer Interval 7.3 to 11.1	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease SCF - H3N1, D21	7.8 Titer Interval 7.2 to 8.5	10.6 Titer Interval 8.6 to 13.0	9.5 Titer Interval 7.7 to 11.6	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease SCF - BRI, D21	6.3 Titer Interval 5.8 to 6.9	4.6 Titer Interval 3.8 to 5.5	2.7 Titer Interval 2.3 to 3.2	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease SCF - FLO, D21	5.2 Titer Interval 4.9 to 5.6	2.6 Titer Interval 2.3 to 3.0	4.4 Titer Interval 3.6 to 5.2	—	—	—

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.

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.

Outcome measures

Measure	GSK2282512A Group n=417 Participants 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.	Victoria Strain FluLaval Group n=421 Participants 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 n=422 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=208 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=216 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	260 Participants	245 Participants	245 Participants	93 Participants	89 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	9 Participants	5 Participants	8 Participants	2 Participants	3 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	8 Participants	11 Participants	3 Participants	6 Participants	3 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	10 Participants	13 Participants	9 Participants	3 Participants	8 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.

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.

Outcome measures

Measure	GSK2282512A Group n=417 Participants 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.	Victoria Strain FluLaval Group n=421 Participants 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 n=422 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=208 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=216 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering	30 Participants	30 Participants	27 Participants	11 Participants	8 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	92 Participants	86 Participants	93 Participants	45 Participants	37 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	6 Participants	2 Participants	2 Participants	2 Participants	4 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	70 Participants	72 Participants	78 Participants	28 Participants	32 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	93 Participants	87 Participants	91 Participants	41 Participants	49 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	4 Participants	3 Participants	4 Participants	1 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle Ache	113 Participants	105 Participants	113 Participants	52 Participants	40 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	66 Participants	60 Participants	72 Participants	28 Participants	35 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle Ache	2 Participants	4 Participants	4 Participants	1 Participants	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle Ache	93 Participants	94 Participants	98 Participants	39 Participants	35 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature	3 Participants	8 Participants	8 Participants	1 Participants	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature	0 Participants	3 Participants	2 Participants	0 Participants	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature	1 Participants	8 Participants	6 Participants	0 Participants	2 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint Pain	27 Participants	27 Participants	34 Participants	17 Participants	15 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering	39 Participants	37 Participants	35 Participants	16 Participants	13 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint Pain	1 Participants	3 Participants	1 Participants	1 Participants	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint Pain	17 Participants	20 Participants	21 Participants	10 Participants	11 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering	4 Participants	2 Participants	2 Participants	1 Participants	2 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastr.	43 Participants	35 Participants	39 Participants	21 Participants	16 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastr.	5 Participants	1 Participants	4 Participants	4 Participants	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastr.	34 Participants	26 Participants	23 Participants	11 Participants	8 Participants	—

SECONDARY outcome

Timeframe: Within the 21-day (Days 0-20) follow-up period after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK2282512A Group n=423 Participants 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.	Victoria Strain FluLaval Group n=424 Participants 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 n=425 Participants 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.	Victoria Strain FluLaval ≥ 65Y Group n=213 Participants 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.	Yamagata Strain FluLaval 18-64Y Group n=218 Participants 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.	Yamagata Strain FluLaval ≥ 65Y Group 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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Subject(s) with Any Unsolicited AE(s)	77 Participants	80 Participants	87 Participants	48 Participants	51 Participants	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Subject(s) with Grade 3 Unsolicited AE(s)	5 Participants	5 Participants	15 Participants	6 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Subject(s) with Related Unsolicited AE(s)	18 Participants	26 Participants	21 Participants	11 Participants	13 Participants	—

SECONDARY outcome

Timeframe: Within the 7-day follow-up period after vaccination (Days 0-6)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.

Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within the 7-day follow-up period after vaccination (Days 0-6)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within the 21-day (Days 0-20) follow-up period post vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

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.

Outcome measures

Outcome data not reported

Adverse Events

GSK2282512A 1 Group

Serious events: 15 serious events

Other events: 294 other events

Deaths: 0 deaths

GSK2282512A 2 Group

Serious events: 13 serious events

Other events: 286 other events

Deaths: 0 deaths

GSK2282512A 3 Group

Serious events: 7 serious events

Other events: 284 other events

Deaths: 0 deaths

Victoria Strain FluLaval Group

Serious events: 3 serious events

Other events: 127 other events

Deaths: 0 deaths

Yamagata Strain FluLaval Group

Serious events: 7 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK2282512A 1 Group n=417 participants at risk；n=423 participants at risk 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.	GSK2282512A 2 Group n=421 participants at risk；n=424 participants at risk 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.	GSK2282512A 3 Group n=422 participants at risk；n=425 participants at risk 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.	Victoria Strain FluLaval Group n=208 participants at risk；n=213 participants at risk 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 n=216 participants at risk；n=218 participants at risk 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.
General disorders Gait disturbance	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
General disorders Pain	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Angina unstable	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.47% 1/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Cardiac failure	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Cardiac failure congestive	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Cardiogenic shock	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Cardiopulmonary failure	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Coronary artery disease	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.46% 1/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Mitral valve incompetence	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Myocardial infarction	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Myocardial ischaemia	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Cardiac disorders Nodal rhythm	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Gastrointestinal disorders Dyspepsia	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Gastrointestinal disorders Dysphagia	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Gastrointestinal disorders Gastrointestinal mucosal disorder	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.47% 1/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Gastrointestinal disorders Pancreatitis acute	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.47% 1/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Hepatobiliary disorders Cholecystitis	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Hepatobiliary disorders Cholecystitis acute	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Hepatobiliary disorders Cholecystitis chronic	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.46% 1/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Hepatobiliary disorders Portal hypertension	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.46% 1/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Infections and infestations Abscess limb	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.46% 1/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Infections and infestations Bronchitis	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.46% 1/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Infections and infestations Diverticulitis	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Infections and infestations Pneumonia	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Infections and infestations Urinary tract infection	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Injury, poisoning and procedural complications Anaemia postoperative	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Injury, poisoning and procedural complications Animal bite	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Injury, poisoning and procedural complications Ankle fracture	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.47% 1/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.47% 1/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.46% 1/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.46% 1/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Injury, poisoning and procedural complications Stab wound	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.46% 1/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Nervous system disorders Cerebrovascular accident	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Nervous system disorders Cerebrovascular disorder	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Nervous system disorders Hypoaesthesia	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.47% 1/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Nervous system disorders Ischaemic stroke	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Renal and urinary disorders Calculus bladder	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Renal and urinary disorders Renal failure chronic	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Reproductive system and breast disorders Cystocele	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.46% 1/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.24% 1/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Vascular disorders Arteriosclerosis	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
Vascular disorders Venous thrombosis limb	0.00% 0/423 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/424 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.24% 1/425 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/213 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	0.00% 0/218 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.

Other adverse events

Measure	GSK2282512A 1 Group n=417 participants at risk；n=423 participants at risk 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.	GSK2282512A 2 Group n=421 participants at risk；n=424 participants at risk 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.	GSK2282512A 3 Group n=422 participants at risk；n=425 participants at risk 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.	Victoria Strain FluLaval Group n=208 participants at risk；n=213 participants at risk 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 n=216 participants at risk；n=218 participants at risk 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.
General disorders Headache	22.3% 93/417 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	20.7% 87/421 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	21.6% 91/422 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	19.7% 41/208 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	22.7% 49/216 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
General disorders Gastrointestinal adverse event(s)	10.3% 43/417 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	8.3% 35/421 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	9.2% 39/422 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	10.1% 21/208 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	6.9% 15/216 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
General disorders Pain	62.4% 260/417 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	58.2% 245/421 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	58.1% 245/422 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	44.7% 93/208 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	41.2% 89/216 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
General disorders Fatigue	22.1% 92/417 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	20.4% 86/421 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	22.0% 93/422 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	21.6% 45/208 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	17.1% 37/216 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
General disorders Muscle aches	27.1% 113/417 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	24.9% 105/421 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	26.8% 113/422 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	25.0% 52/208 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	18.5% 40/216 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
General disorders Shivering	9.4% 39/417 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	8.8% 37/421 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	8.3% 35/422 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	7.7% 16/208 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	6.0% 13/216 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.
General disorders Joint pain at other location than injection site	6.5% 27/417 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	6.4% 27/421 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	8.1% 34/422 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	8.2% 17/208 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.	6.9% 15/216 • 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. Other Adverse Events were collected only from participants who completed their symptoms sheet.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER