Trial Outcomes & Findings for Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age (NCT NCT00397215)

Last Updated: 2019-06-10

Results Overview

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

437 participants

Primary outcome timeframe

At Days 0, 21 and 42

Results posted on

2019-06-10

Participant Flow

Subjects not previously vaccinated with an influenza vaccine for the 2006-2007 season were administered FluarixTM vaccine intramuscularly at least 3 weeks before administration of the first dose(s) of the GSK1562902A vaccine.

Participant milestones

Participant milestones
Measure	GSK1562902A 1 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Month 0 (Day 0) STARTED	165	61	159	52
Month 0 (Day 0) COMPLETED	158	56	153	48
Month 0 (Day 0) NOT COMPLETED	7	5	6	4
Month 6 (Day 180) STARTED	164	58	158	51
Month 6 (Day 180) COMPLETED	162	55	153	51
Month 6 (Day 180) NOT COMPLETED	2	3	5	0
Month 12 (Day 360) STARTED	130	48	125	42
Month 12 (Day 360) COMPLETED	130	48	125	42
Month 12 (Day 360) NOT COMPLETED	0	0	0	0
Month 24 (Day 720) STARTED	122	45	117	36
Month 24 (Day 720) COMPLETED	122	45	117	36
Month 24 (Day 720) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1562902A 1 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Month 0 (Day 0) Adverse Event	0	1	0	0
Month 0 (Day 0) Withdrawal by Subject	3	3	3	1
Month 0 (Day 0) Other	4	1	3	3
Month 6 (Day 180) Adverse Event	0	3	2	0
Month 6 (Day 180) Other	2	0	3	0

Baseline Characteristics

Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1562902A 1 Group n=165 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=61 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=159 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=52 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	Total n=437 Participants Total of all reporting groups
Age, Continuous	69.7 Years STANDARD_DEVIATION 6.33 • n=5 Participants	69.9 Years STANDARD_DEVIATION 6.38 • n=7 Participants	69.7 Years STANDARD_DEVIATION 6.51 • n=5 Participants	70.8 Years STANDARD_DEVIATION 7.35 • n=4 Participants	70.0 Years STANDARD_DEVIATION 6.64 • n=21 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	28 Participants n=7 Participants	77 Participants n=5 Participants	23 Participants n=4 Participants	200 Participants n=21 Participants
Sex: Female, Male Male	93 Participants n=5 Participants	33 Participants n=7 Participants	82 Participants n=5 Participants	29 Participants n=4 Participants	237 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Days 0, 21 and 42

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable 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.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=152 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=54 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=145 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=44 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004, Day 0	11.3 Titer Interval 9.2 to 13.9	9.7 Titer Interval 7.3 to 13.0	10.2 Titer Interval 8.4 to 12.5	8.8 Titer Interval 6.6 to 11.8
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004, Day 21	50.0 Titer Interval 38.1 to 65.6	16.8 Titer Interval 11.7 to 24.0	69.4 Titer Interval 52.1 to 92.3	20.8 Titer Interval 13.0 to 33.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004, Day 42	126.8 Titer Interval 99.4 to 161.7	22.7 Titer Interval 15.1 to 34.1	237.3 Titer Interval 191.9 to 293.6	25.3 Titer Interval 16.0 to 40.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonezia/5/2005, Day 0	5.1 Titer Interval 5.0 to 5.1	5.2 Titer Interval 4.9 to 5.5	5.1 Titer Interval 5.0 to 5.2	5.0 Titer Interval 5.0 to 5.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonezia/5/2005, Day 21	6.9 Titer Interval 6.2 to 7.7	5.3 Titer Interval 4.8 to 5.9	8.6 Titer Interval 7.3 to 10.1	5.6 Titer Interval 5.0 to 6.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonezia/5/2005, Day 42	13.7 Titer Interval 11.3 to 16.4	6.1 Titer Interval 5.1 to 7.4	24.4 Titer Interval 19.9 to 30.0	6.3 Titer Interval 5.2 to 7.6

PRIMARY outcome

Timeframe: At Days 21 and 42

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=152 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=54 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=145 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=44 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. A/Vietnam/1994/2004, Day 21	4.4 Fold Interval 3.5 to 5.5	1.7 Fold Interval 1.3 to 2.3	6.8 Fold Interval 5.3 to 8.6	2.4 Fold Interval 1.7 to 3.4
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. A/Vietnam/1994/2004, Day 42	11.2 Fold Interval 8.9 to 14.1	2.3 Fold Interval 1.6 to 3.3	23.2 Fold Interval 18.5 to 29.0	2.9 Fold Interval 2.0 to 4.1
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. A/Indonezia/5/2005, Day 21	1.4 Fold Interval 1.2 to 1.5	1.0 Fold Interval 0.9 to 1.1	1.7 Fold Interval 1.4 to 2.0	1.1 Fold Interval 1.0 to 1.3
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. A/Indonezia/5/2005, Day 42	2.7 Fold Interval 2.2 to 3.2	1.2 Fold Interval 1.0 to 1.4	4.8 Fold Interval 3.9 to 5.9	1.3 Fold Interval 1.0 to 1.5

PRIMARY outcome

Timeframe: At Days 0, 21 and 42

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=152 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=54 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=145 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=44 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, Day 0	28 Subjects	7 Subjects	23 Subjects	2 Subjects
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, Day 21	93 Subjects	15 Subjects	90 Subjects	15 Subjects
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004, Day 42	127 Subjects	19 Subjects	139 Subjects	17 Subjects
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonezia/5/2005, Day 0	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonezia/5/2005, Day 21	5 Subjects	1 Subjects	13 Subjects	1 Subjects
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonezia/5/2005, Day 42	35 Subjects	2 Subjects	59 Subjects	2 Subjects

PRIMARY outcome

Timeframe: At Days 0 and 42

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=87 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=82 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004, Day 0	121.1 Titer Interval 94.6 to 154.9	112.5 Titer Interval 90.7 to 139.5	—	—
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004, Day 42	447.3 Titer Interval 359.3 to 557.0	595.8 Titer Interval 487.7 to 727.8	—	—
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonesia/5/2005, Day 0	44.2 Titer Interval 36.0 to 54.1	39.7 Titer Interval 32.0 to 49.3	—	—
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonesia/5/2005, Day 42	107.5 Titer Interval 88.9 to 130.0	169.6 Titer Interval 144.7 to 198.9	—	—

PRIMARY outcome

Timeframe: At Days 21 and 42

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 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=152 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=54 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=145 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=44 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Vietnam/1194/2004, Day 21 (N=152,54,145,44)	69 Subjects	8 Subjects	76 Subjects	8 Subjects
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Vietnam/1194/2004, Day 42 (N=152,54,145,44)	110 Subjects	12 Subjects	128 Subjects	10 Subjects
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Indonezia/5/2005, Day 21 (N=152,54,145,44)	5 Subjects	1 Subjects	13 Subjects	1 Subjects
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Indonezia/5/2005, Day 42 (N=152,54,145,44)	35 Subjects	2 Subjects	58 Subjects	2 Subjects

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable 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.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=87 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=82 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. A/Vitenam/1194/2004, Day 42	39 Subjects	46 Subjects	—	—
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. A/Indonesia/5/2005, Day 42	25 Subjects	40 Subjects	—	—

PRIMARY outcome

Timeframe: At Day 180

Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=140 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=50 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=131 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=44 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004	38.5 Titers Interval 30.0 to 49.5	16.3 Titers Interval 11.0 to 24.3	53.5 Titers Interval 41.9 to 68.4	13.1 Titers Interval 8.9 to 19.2
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonezia/5/2005	6.6 Titers Interval 6.0 to 7.3	5.5 Titers Interval 4.8 to 6.4	8.6 Titers Interval 7.5 to 9.9	5.2 Titers Interval 4.8 to 5.5

PRIMARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=112 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=45 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=106 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=35 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004	21.4 Titer Interval 16.4 to 28.0	13.3 Titer Interval 9.3 to 19.0	26.5 Titer Interval 20.3 to 34.6	11.4 Titer Interval 7.7 to 16.7
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonezia/5/2005	9.8 Titer Interval 8.2 to 11.7	6.6 Titer Interval 5.5 to 7.9	13.1 Titer Interval 10.9 to 15.8	6.9 Titer Interval 5.4 to 8.9

PRIMARY outcome

Timeframe: At Month 24

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=86 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=37 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=81 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=24 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004	17.6 Titer Interval 13.7 to 22.5	12.3 Titer Interval 8.9 to 16.9	18.4 Titer Interval 14.2 to 23.8	9.8 Titer Interval 6.7 to 14.4
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonezia/5/2005	7.0 Titer Interval 6.1 to 8.1	5.6 Titer Interval 4.9 to 6.4	7.3 Titer Interval 6.2 to 8.6	5.0 Titer Interval 5.0 to 5.0

PRIMARY outcome

Timeframe: At Day 180

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=140 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=48 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=130 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=42 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Vietnam/1194/2004	52 Subjects	6 Subjects	70 Subjects	6 Subjects
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Indonezia/5/2005	5 Subjects	1 Subjects	8 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=112 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=43 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=105 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=34 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Vietnam/1194/2004	24 Subjects	6 Subjects	24 Subjects	4 Subjects
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Indonezia/5/2005	17 Subjects	2 Subjects	22 Subjects	3 Subjects

PRIMARY outcome

Timeframe: At Month 24

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=86 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=36 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=81 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=22 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Vietnam/1194/2004	8 Subjects	2 Subjects	9 Subjects	2 Subjects
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. A/Indonezia/5/2005	4 Subjects	1 Subjects	4 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 180

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=140 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=48 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=130 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=42 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. A/Vietnam/1994/2004	3.3 Fold Interval 2.7 to 4.0	1.6 Fold Interval 1.2 to 2.2	5.4 Fold Interval 4.4 to 6.7	1.8 Fold Interval 1.3 to 2.4
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. A/Indonezia/5/2005	1.3 Fold Interval 1.2 to 1.4	1.1 Fold Interval 0.9 to 1.3	1.7 Fold Interval 1.5 to 1.9	1.0 Fold Interval 1.0 to 1.1

PRIMARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=112 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=43 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=105 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=34 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1994/2004	1.8 Fold Interval 1.5 to 2.2	1.3 Fold Interval 1.0 to 1.7	2.5 Fold Interval 2.0 to 3.0	1.5 Fold Interval 1.1 to 2.1
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonezia/5/2005	1.9 Fold Interval 1.6 to 2.3	1.3 Fold Interval 1.1 to 1.6	2.6 Fold Interval 2.2 to 3.1	1.4 Fold Interval 1.1 to 1.8

PRIMARY outcome

Timeframe: At Month 24

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=86 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=36 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=81 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=22 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Vietnam/1994/2004	1.5 Fold Interval 1.3 to 1.8	1.3 Fold Interval 0.9 to 1.7	1.9 Fold Interval 1.6 to 2.3	1.4 Fold Interval 1.0 to 2.1
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/Indonezia/5/2005	1.4 Fold Interval 1.2 to 1.6	1.1 Fold Interval 1.0 to 1.3	1.4 Fold Interval 1.2 to 1.7	1.0 Fold Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 180

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=140 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=50 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=131 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=44 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004	74 Subjects	13 Subjects	91 Subjects	9 Subjects
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonezia/5/2005	5 Subjects	1 Subjects	8 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=112 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=45 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=106 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=35 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004	49 Subjects	11 Subjects	45 Subjects	7 Subjects
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonezia/5/2005	17 Subjects	2 Subjects	22 Subjects	3 Subjects

PRIMARY outcome

Timeframe: At Month 24

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=86 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=37 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=81 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=24 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Vietnam/1194/2004	32 Subjects	6 Subjects	25 Subjects	2 Subjects
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease A/Indonezia/5/2005	4 Subjects	1 Subjects	5 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 180

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=76 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=73 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. A/Vietnam/1194/2004	16 Subjects	21 Subjects	—	—
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. A/Indonesia/5/2005	20 Subjects	32 Subjects	—	—

PRIMARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=69 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=71 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. A/Vietnam/1194/2004	18 Subjects	21 Subjects	—	—
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. A/Indonesia/5/2005	13 Subjects	28 Subjects	—	—

PRIMARY outcome

Timeframe: At Month 24

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=49 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=54 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. A/Vietnam/1194/2004	18 Subjects	22 Subjects	—	—
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. A/Indonesia/5/2005	6 Subjects	16 Subjects	—	—

PRIMARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=69 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=71 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004	274.7 Titer Interval 213.4 to 353.5	268.8 Titer Interval 211.4 to 341.8	—	—
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonesia/5/2005	82.5 Titer Interval 63.0 to 107.9	119.8 Titer Interval 94.0 to 152.7	—	—

PRIMARY outcome

Timeframe: At Month 24

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=76 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=73 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004	391.0 Titer Interval 295.5 to 517.5	382.8 Titer Interval 317.4 to 461.6	—	—
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonesia/5/2005	75.4 Titer Interval 57.2 to 99.4	84.9 Titer Interval 67.0 to 107.6	—	—

PRIMARY outcome

Timeframe: At Day 180

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=76 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=73 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Vietnam/1194/2004	218.2 Titer Interval 172.4 to 276.2	260.9 Titer Interval 207.7 to 327.8	—	—
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. A/Indonesia/5/2005	97.8 Titer Interval 82.0 to 116.5	134.5 Titer Interval 113.4 to 159.7	—	—

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Month 24)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, on a subset of subjects enrolled for this study in Belgium.

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Note: No AESIs were reported during the entire study period.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.

Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=164 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=61 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=159 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=51 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Ecchymosis	1 Subjects	0 Subjects	5 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Induration	10 Subjects	0 Subjects	15 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Pain	69 Subjects	6 Subjects	75 Subjects	3 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Redness	19 Subjects	0 Subjects	30 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Swelling	19 Subjects	0 Subjects	15 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Ecchymosis >100mm	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Induration >100mm	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	0 Subjects	0 Subjects	2 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Redness >100mm	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Swelling >100mm	0 Subjects	0 Subjects	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: At Days 0, 2, 21 and 23

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

Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT, AST, BAS, CREA and CRPH.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=165 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=61 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=159 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=52 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, PRE (Day 0), Below (N=165,61,159,52)	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, PRE (Day 0), Normal (N=165,61,159,52)	152 Subjects	58 Subjects	152 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, PRE (Day 0), Above (N=165,61,159.52)	13 Subjects	3 Subjects	6 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, POST (Day2), Below (N=165,61,158,52)	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, POST (Day2), Normal (N=165,61,158,52)	152 Subjects	59 Subjects	151 Subjects	48 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, POST (Day 2), Above (N=165,61,158,52)	13 Subjects	2 Subjects	6 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, POST (Day 21), Below (N=163,57,156,52)	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, POST (Day 21), Normal (N=163,57,156,52)	153 Subjects	54 Subjects	144 Subjects	48 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, POST (Day 21), Above (N=163,57,156,52)	10 Subjects	3 Subjects	11 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, POST (Day23), Below (N=163,57,155,52)	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, POST (Day 23), Normal (N=163,57,155,52)	152 Subjects	55 Subjects	146 Subjects	49 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. ALT, POST (Day 23), Above (N=163,57,155,52)	11 Subjects	2 Subjects	8 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, PRE (Day 0), Below (N=165,61,159,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, PRE (Day 0), Normal (N=165,61,159,52)	154 Subjects	57 Subjects	150 Subjects	48 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, PRE (Day 0), Above (N=165,61,159,52)	11 Subjects	4 Subjects	9 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, POST (Day 2), Below (N=165,61,158,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, POST (Day 2), Normal (N=165,61,158,52)	154 Subjects	59 Subjects	152 Subjects	49 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, POST (Day 2), Above (N=165,61,158,52)	11 Subjects	2 Subjects	6 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, POST (Day 21), Below (N=163,57,156,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, POST (Day 21), Normal (N=163,57,156,52)	154 Subjects	51 Subjects	146 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, POST (Day 21), Above (N=163,57,156,52)	9 Subjects	6 Subjects	10 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, POST (Day 23), Below (N=163,57,155,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, POST (Day 23), Normal (N=163,57,155,52)	153 Subjects	54 Subjects	149 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. AST, POST (Day 23), Above (N=163,57,155,52)	10 Subjects	3 Subjects	6 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, PRE (Day 0), Below (N=163,61,159,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, PRE (Day 0), Normal (N=163,61,159,52)	163 Subjects	61 Subjects	159 Subjects	52 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, PRE (Day 0), Above (N=163,61,159,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, POST (Day 2), Below (N=165,61,158,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, POST (Day 2), Normal (N=165,61,158,52)	164 Subjects	61 Subjects	158 Subjects	52 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, POST (Day 2), Above (N=165,61,158,52)	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, POST (Day 21), Below (N=163,57,155,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, POST (Day 21), Normal (N=163,57,155,52)	163 Subjects	57 Subjects	155 Subjects	52 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, POST (Day 21), Above (N=163,57,155,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, POST (Day 23), Below (N=163, 57,155,51)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, POST (Day 23), Below (N=163,57,155,51)	163 Subjects	57 Subjects	155 Subjects	51 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. BAS, POST (Day 23), Above (N=163,57,155,51)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, PRE (Day 0), Below (N=165,61,159,52)	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, PRE (Day 0), Normal (N=165,61,159,52)	144 Subjects	54 Subjects	148 Subjects	43 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, PRE (Day 0), Above (N=165,61,159,52)	21 Subjects	6 Subjects	11 Subjects	9 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, POST (Day 2), Below (N=165,61,158,51)	1 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, POST (Day 2), Normal (N=165,61,158,51)	144 Subjects	55 Subjects	146 Subjects	42 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, POST (Day 2), Above (N=165,61,158,51)	20 Subjects	6 Subjects	11 Subjects	9 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, POST (Day 21), Below (N=163,57,156,52)	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, POST (Day 21), Normal (N=163,57,156,52)	134 Subjects	51 Subjects	142 Subjects	42 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, POST (Day 21), Above (N=163,57,156,52)	29 Subjects	6 Subjects	13 Subjects	10 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, POST (Day 23), Below (N=163,57,155,52)	1 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, POST (Day 23), Normal (N=163,57,155,52)	142 Subjects	49 Subjects	139 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CREA, POST (Day 23), Above (N=163,57,155,52)	20 Subjects	8 Subjects	15 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, PRE (Day 0), Below (N=165,60,158,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, PRE (Day 0), Normal (N=165,60,158,52)	149 Subjects	45 Subjects	136 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, PRE (Day 0), Above (N=165,60,158,52)	16 Subjects	15 Subjects	22 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, POST (Day 2), Below (N=165,61,158,52)	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, POST (Day 2), Normal (N=165,61,158,52)	150 Subjects	49 Subjects	141 Subjects	44 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, POST (Day 2), Above (N=165,61,158,52)	15 Subjects	12 Subjects	16 Subjects	8 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, POST (Day 21), Below (N=163,57,156,52)	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, POST (Day 21), Normal (N=163,57,156,52)	140 Subjects	45 Subjects	130 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, POST (Day 21), Above (N=163,57,156,52)	22 Subjects	12 Subjects	26 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, POST (Day 23), Below (N=163,57,155,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, POST (Day 23), Normal (N=163,57,155,52)	146 Subjects	49 Subjects	136 Subjects	44 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. CRPH, POST (Day 23), Above (N=163,57,155,52)	17 Subjects	8 Subjects	19 Subjects	8 Subjects

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Month 24).

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: The study period was divided into 4 consecutive periods (Days 0-51, Days 52-180 \[Month 6\], Months 6-12 and Months 12-24), for which SAEs were collected.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=165 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=61 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=159 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=52 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Subjects With Serious Adverse Events (SAEs) Subjects with SAEs Days 0-51 [N=165,61,159,52]	1 Subjects	1 Subjects	1 Subjects	1 Subjects
Number of Subjects With Serious Adverse Events (SAEs) Subjects with SAEs Days 52-180 [N=164,58,158,51]	5 Subjects	3 Subjects	5 Subjects	0 Subjects
Number of Subjects With Serious Adverse Events (SAEs) Subjects with SAEs Months 6-12 [N=130,48,125,42]	4 Subjects	0 Subjects	3 Subjects	2 Subjects
Number of Subjects With Serious Adverse Events (SAEs) Subjects with SAEs Months 12-24 [N=122,45,117,36]	9 Subjects	7 Subjects	7 Subjects	2 Subjects

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=165 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=61 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=159 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=52 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Subjects with any AEs	36 Subjects	16 Subjects	28 Subjects	8 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Subjects with Grade 3 AEs	5 Subjects	2 Subjects	3 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Subjects with related AEs	9 Subjects	2 Subjects	10 Subjects	1 Subjects

SECONDARY outcome

Timeframe: At Days 0, 2, 21 and 23.

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=165 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=61 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=159 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=52 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, POST (Day 23), Normal (N=163,57,155,51)	159 Subjects	57 Subjects	149 Subjects	49 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, PRE (Day 0), Below (N=163,61,159,52)	4 Subjects	3 Subjects	5 Subjects	2 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, PRE (Day 0), Normal (N=163,61,159,52)	159 Subjects	58 Subjects	153 Subjects	50 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, PRE (Day 0), Above (N=163,61,159,52)	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, POST (Day 2), Below (N=165,61,158,52)	4 Subjects	3 Subjects	5 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, POST (Day 2), Normal (N=165,61,158,52)	161 Subjects	58 Subjects	152 Subjects	49 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, POST (Day 2), Above (N=165,61,158,52)	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, POST (Day 21), Below (N=163,57,155,52)	4 Subjects	0 Subjects	4 Subjects	2 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, POST (Day 21), Normal (N=163,57,155,52)	158 Subjects	57 Subjects	150 Subjects	50 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, POST (Day 21), Above (N=163,57,155,52)	1 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, POST (Day 23), Below (N=163,57,155,51)	4 Subjects	0 Subjects	4 Subjects	2 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. EOS, POST (Day 23), Above (N=163,57,155,51)	0 Subjects	0 Subjects	2 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, PRE (Day 0), Below (N=163,61,159,52)	11 Subjects	3 Subjects	14 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, PRE (Day 0), Normal (N=163,61,159,52)	137 Subjects	50 Subjects	130 Subjects	43 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, PRE (Day 0), Above (N=163,61,159,52)	15 Subjects	8 Subjects	15 Subjects	6 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, POST (Day 2), Below (N=165,61,158,52)	21 Subjects	6 Subjects	16 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, POST (Day 2), Normal (N=165,61,158,52)	139 Subjects	53 Subjects	135 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, POST (Day 2), Above (N=165,61,158,52)	5 Subjects	2 Subjects	7 Subjects	2 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, POST (Day 21), Below (N=163,57,155,52)	13 Subjects	2 Subjects	15 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, POST (Day 21), Normal (N=163,57,155,52)	144 Subjects	53 Subjects	130 Subjects	44 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, POST (Day 21), Above (N=163,57,155,52)	6 Subjects	2 Subjects	10 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, POST (Day 23), Below (N=163,57,155,52)	20 Subjects	3 Subjects	17 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, POST (Day 23), Normal (N=163,57,155,52)	139 Subjects	54 Subjects	133 Subjects	44 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. HEM, POST (Day 23), Above (N=163,57,155,52)	4 Subjects	0 Subjects	5 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, PRE (Day 0), Below (N=164,61,156,52)	1 Subjects	2 Subjects	2 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, PRE (Day 0), Normal (N=164,61,156,52)	147 Subjects	51 Subjects	136 Subjects	49 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, PRE (Day 0), Above (N=164,61,156,52)	16 Subjects	8 Subjects	18 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, POST (Day 2), Below (N=165,61,158,52)	2 Subjects	1 Subjects	2 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, PRE (Day 2), Normal (N=165,61,158,52)	148 Subjects	56 Subjects	144 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, PRE (Day 2), Above (N=165,61,158,52)	15 Subjects	4 Subjects	12 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, POST (Day 21), Below (N=162,57,156,52)	0 Subjects	1 Subjects	1 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, POST (Day 21), Normal (N=162,57,156,52)	151 Subjects	44 Subjects	142 Subjects	48 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, POST (Day 21), Above (N=162,57,156,52)	11 Subjects	12 Subjects	13 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, POST (Day 23), Below (N=163,57,155,52)	4 Subjects	1 Subjects	2 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, POST (Day 23), Normal (N=163,57,155,52)	147 Subjects	54 Subjects	141 Subjects	50 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LDE, POST (Day 23), Above (N=163,57,155,52)	12 Subjects	2 Subjects	12 Subjects	2 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, PRE (Day 0), Below (N=163,61,159,52)	145 Subjects	53 Subjects	137 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, PRE (Day 0), Normal (N=163,61,159,52)	18 Subjects	8 Subjects	22 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, PRE (Day 0), Above (N=163,61,159,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, POST (Day 2), Below (N=165,61,158,52)	148 Subjects	53 Subjects	136 Subjects	46 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, POST (Day 2), Normal (N=165,61,158,52)	17 Subjects	8 Subjects	22 Subjects	6 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, POST (Day 2), Above (N=165,61,158,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, POST (Day 21), Below (N=163,57,155,52)	144 Subjects	52 Subjects	135 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, POST (Day 21), Normal (N=163,57,155,52)	19 Subjects	5 Subjects	20 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, POST (Day 21), Above (N=163,57,155,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, POST (Day 23), Below (N=163,57,155,51)	145 Subjects	52 Subjects	135 Subjects	44 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, POST (Day 23), Normal (N=163,57,155,51)	17 Subjects	5 Subjects	20 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. LYM, POST (Day 23), Above (N=163,57,155,51)	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, PRE (Day 0), Below (N=163,61,159,52)	143 Subjects	52 Subjects	136 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, PRE (Day 0), Normal (N=163,61,159,52)	20 Subjects	9 Subjects	23 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, PRE (Day 0), Above (N=163,61,159,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, POST (Day 2), Below (N=165,61,158,52)	143 Subjects	53 Subjects	134 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, POST (Day 2), Normal (N=165,61,158,52)	21 Subjects	8 Subjects	24 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, POST (Day 2), Above (N=165,61,158,52)	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, POST (Day 21), Below (N=163,57,155,52)	140 Subjects	52 Subjects	134 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, POST (Day 21), Normal (N=163,57,155,52)	23 Subjects	5 Subjects	21 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, POST (Day 21), Above (N=163,57,155,52)	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, POST (Day 23), Below (N=163,57,155,51)	141 Subjects	52 Subjects	134 Subjects	44 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, POST (Day 23), Normal (N=163,57,155,51)	19 Subjects	5 Subjects	17 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. MON, POST (Day 23), Above (N=163,57,155,51)	3 Subjects	0 Subjects	4 Subjects	0 Subjects

SECONDARY outcome

Timeframe: At Month 12

The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand \[CD40L\], interleukin-2 \[IL-2\], tumor necrosis factor-alpha \[TNF-α\] or interferon-gamma \[IFN-γ\].

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=90 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=41 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=91 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=30 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4 All doubles	898.52 Cells Standard Deviation 1050.39	693.48 Cells Standard Deviation 668.33	1170.36 Cells Standard Deviation 1021.43	869.43 Cells Standard Deviation 632.5
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-CD40L	934.35 Cells Standard Deviation 1020.83	675.52 Cells Standard Deviation 655.85	1146.47 Cells Standard Deviation 1002.22	850.8 Cells Standard Deviation 612.75
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-IL-2	902.69 Cells Standard Deviation 1006.77	623.44 Cells Standard Deviation 623.44	1118.63 Cells Standard Deviation 973.32	798.58 Cells Standard Deviation 598.14
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-INF-g	442.66 Cells Standard Deviation 743.99	442.16 Cells Standard Deviation 419.92	586.6 Cells Standard Deviation 577.71	542.62 Cells Standard Deviation 471.58
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-TNF-a	678.6 Cells Standard Deviation 870.28	515.7 Cells Standard Deviation 484.61	884.64 Cells Standard Deviation 847.51	647.75 Cells Standard Deviation 528.32
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8 All doubles	34.28 Cells Standard Deviation 275.22	29.42 Cells Standard Deviation 283.23	27.88 Cells Standard Deviation 261.68	34.21 Cells Standard Deviation 838.37
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-CD40L	2.08 Cells Standard Deviation 28.46	2.22 Cells Standard Deviation 20.24	2.99 Cells Standard Deviation 28.9	2.48 Cells Standard Deviation 31.11
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-IL-2	18.84 Cells Standard Deviation 167.58	24.72 Cells Standard Deviation 153.94	19.95 Cells Standard Deviation 164.36	28.85 Cells Standard Deviation 598.65
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-INF-g	29.13 Cells Standard Deviation 271.12	24.45 Cells Standard Deviation 285.49	20.75 Cells Standard Deviation 260.19	32.99 Cells Standard Deviation 829.25
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-TNF-a	35.67 Cells Standard Deviation 251.66	32.59 Cells Standard Deviation 230.03	28.15 Cells Standard Deviation 246.49	31.35 Cells Standard Deviation 595.41

SECONDARY outcome

Timeframe: At Month 24

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=73 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=34 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=72 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=22 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4 All doubles [N=73,34,72,22]	779.93 Cells Standard Deviation 771.46	569.84 Cells Standard Deviation 1058.95	1126.86 Cells Standard Deviation 1375.31	832.74 Cells Standard Deviation 908.25
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-CD40L [N=73,34,72,22]	710.53 Cells Standard Deviation 712.25	454.56 Cells Standard Deviation 1060.83	1041.16 Cells Standard Deviation 1356.01	740.77 Cells Standard Deviation 820.93
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-IL-2 [N=73,34,72,22]	769.56 Cells Standard Deviation 718.28	509.21 Cells Standard Deviation 1039.78	1043.95 Cells Standard Deviation 1333.41	783.88 Cells Standard Deviation 868.28
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-INF-g [N=73,34,72,22]	455.05 Cells Standard Deviation 608.16	391.45 Cells Standard Deviation 923.81	651.02 Cells Standard Deviation 947.13	563.18 Cells Standard Deviation 849.25
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-TNF-a [N=73,34,72,22]	500.82 Cells Standard Deviation 555.63	374.53 Cells Standard Deviation 962.01	806.94 Cells Standard Deviation 1012.4	598.88 Cells Standard Deviation 860.46
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8 All doubles [N=73,33,72,22]	8.05 Cells Standard Deviation 94.19	8.06 Cells Standard Deviation 60.49	21.67 Cells Standard Deviation 258.83	14.92 Cells Standard Deviation 381.27
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-CD40L [N=73,33,72,22]	1.94 Cells Standard Deviation 29.28	2.65 Cells Standard Deviation 33.03	2.58 Cells Standard Deviation 32.7	1.48 Cells Standard Deviation 18.2
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-IL-2 [N=73,33,72,22]	5.04 Cells Standard Deviation 65.04	4.16 Cells Standard Deviation 69.59	8.16 Cells Standard Deviation 181.28	6.51 Cells Standard Deviation 310.91
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-INF-g [N=73,33,72,22]	7.43 Cells Standard Deviation 93.13	9.05 Cells Standard Deviation 79.82	23.39 Cells Standard Deviation 257.7	12.47 Cells Standard Deviation 382.05
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-TNF-a [N=73,33,72,22]	4.76 Cells Standard Deviation 65.03	4.05 Cells Standard Deviation 51.49	17.22 Cells Standard Deviation 231.77	15.3 Cells Standard Deviation 325.83

SECONDARY outcome

Timeframe: At Days 0, 2, 21 and 23.

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (HEM), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents NEU, PLA, RBC, URE and WBC results.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=165 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=61 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=159 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=52 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, PRE (Day 0), Below (N=163,61,158,52)	148 Subjects	55 Subjects	141 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, PRE (Day 0), Normal (N=163,61,158,52)	13 Subjects	5 Subjects	17 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, PRE (Day 0), Above (N=163,61,158,52)	2 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, POST (Day 2), Below (N=165,61,158,52)	149 Subjects	55 Subjects	141 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, POST (Day 23), Below (N=163,57,155,52)	0 Subjects	0 Subjects	2 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, POST (Day 23), Normal (N=163,57,155,52)	105 Subjects	36 Subjects	106 Subjects	36 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, POST (Day 2), Normal (N=165,61,158,52)	13 Subjects	6 Subjects	17 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, POST (Day 2), Above (N=165,61,158,52)	3 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, POST (Day 21), Below (N=163,57,155,52)	147 Subjects	52 Subjects	138 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, POST (Day 21), Normal (N=163,57,155,52)	14 Subjects	4 Subjects	15 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, POST (Day 21), Above (N=163,57,155,52)	2 Subjects	1 Subjects	2 Subjects	1 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, POST (Day 23), Below (N=163,57,155,51)	148 Subjects	52 Subjects	138 Subjects	46 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, POST (Day 23), Normal (N=163,57,155,51)	14 Subjects	4 Subjects	17 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. NEU, POST (Day 23), Above (N=163,57,155,51)	1 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, PRE (Day 0), Below (N=163,61,159,52)	4 Subjects	4 Subjects	3 Subjects	2 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, PRE (Day 0), Normal (N=163,61,159,52)	145 Subjects	51 Subjects	148 Subjects	46 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, PRE (Day 0), Above (N=163,61,159,52)	14 Subjects	6 Subjects	8 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, POST (Day 2), Below (N=165,61,158,52)	2 Subjects	2 Subjects	4 Subjects	2 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, POST (Day 2), Normal (N=165,61,158,52)	152 Subjects	51 Subjects	147 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, POST (Day 2), Above (N=165,61,158,52)	11 Subjects	8 Subjects	7 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, POST (Day 21), Below (N=163,57,155,52)	3 Subjects	6 Subjects	4 Subjects	1 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, POST (Day 21), Normal (N=163,57,155,52)	147 Subjects	49 Subjects	145 Subjects	46 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, POST (Day 21), Above (N=163,57,155,52)	13 Subjects	2 Subjects	6 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, POST (Day 23), Below (N=163,57,155,52)	2 Subjects	3 Subjects	2 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, POST (Day 23), Normal (N=163,57,155,52)	150 Subjects	52 Subjects	147 Subjects	48 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. PLA, POST (Day 23), Above (N=163,57,155,52)	11 Subjects	2 Subjects	6 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, PRE (Day 0), Below (N=163,61,159,52)	21 Subjects	5 Subjects	21 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, PRE (Day 0), Normal (N=163,61,159,52)	132 Subjects	54 Subjects	125 Subjects	42 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, PRE (Day 0), Above (N=163,61,159,52)	10 Subjects	2 Subjects	13 Subjects	5 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, POST (Day 2), Below (N=165,61,158,52)	25 Subjects	8 Subjects	20 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, POST (Day 2), Normal (N=165,61,158,52)	134 Subjects	52 Subjects	133 Subjects	43 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, POST (Day 2), Above (N=165,61,158,52)	6 Subjects	1 Subjects	5 Subjects	2 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, POST (Day 21), Below (N=163,57,155,52)	24 Subjects	6 Subjects	20 Subjects	7 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, POST (Day 21), Normal (N=163,57,155,52)	133 Subjects	47 Subjects	127 Subjects	42 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, POST (Day 21), Above(N=163,57,155,52)	6 Subjects	4 Subjects	8 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, POST (Day23), Below (N=163,57,155,52)	33 Subjects	8 Subjects	19 Subjects	8 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, POST (Day23), Normal (N=163,57,155,52)	127 Subjects	47 Subjects	134 Subjects	43 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. RBC, POST (Day23), Above (N=163,57,155,52)	3 Subjects	2 Subjects	2 Subjects	1 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, PRE (Day 0), Below (N=165,61,159,52)	0 Subjects	0 Subjects	4 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, PRE (Day 0), Normal (N=165,61,159,52)	90 Subjects	36 Subjects	101 Subjects	34 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, PRE (Day 0), Above (N=165,61,159,52)	75 Subjects	25 Subjects	54 Subjects	18 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, POST (Day 2), Below (N=164,61,158,52)	1 Subjects	0 Subjects	4 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, POST (Day 2), Normal (N=164,61,158,52)	96 Subjects	38 Subjects	114 Subjects	32 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, POST (Day 2), Above (N=164,61,158,52)	67 Subjects	23 Subjects	40 Subjects	20 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, POST (Day 21), Below (N=163,57,156,52)	0 Subjects	0 Subjects	3 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, POST (Day 21), Normal (N=163,57,156,52)	91 Subjects	30 Subjects	100 Subjects	32 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, POST (Day 21), Above (N=163,57,156,52)	72 Subjects	27 Subjects	53 Subjects	20 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. URE, POST (Day 23), Above (N=163,57,155,52)	58 Subjects	21 Subjects	47 Subjects	16 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, PRE (Day 0), Below (N=163,61,159,52)	5 Subjects	2 Subjects	3 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, PRE (Day 0), Normal (N=163,61,159,52)	152 Subjects	56 Subjects	155 Subjects	45 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, PRE (Day 0), Above (N=163,61,159,52)	6 Subjects	3 Subjects	1 Subjects	4 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, POST (Day 2), Below (N=165,61,158,52)	4 Subjects	2 Subjects	4 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, POST (Day 2), Normal (N=165,61,158,52)	152 Subjects	56 Subjects	152 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, POST (Day 2), Above (N=165,61,158,52)	9 Subjects	3 Subjects	2 Subjects	2 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, POST (Day 21), Below (N=163,57,155,52)	4 Subjects	2 Subjects	3 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, POST (Day 21), Normal (N=163,57,155,52)	150 Subjects	53 Subjects	149 Subjects	49 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, POST (Day 21), Above (N=163,57,155,52)	9 Subjects	2 Subjects	3 Subjects	0 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, POST (Day 23), Below (N=163,57,155,52)	6 Subjects	4 Subjects	7 Subjects	3 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, POST (Day 23), Normal (N=163,57,155,52)	145 Subjects	49 Subjects	148 Subjects	47 Subjects
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. WBC, POST (Day 23), Above (N=163,57,155,52)	12 Subjects	4 Subjects	0 Subjects	2 Subjects

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand \[CD40L\], interleukin-2 \[IL-2\], interferon gamma \[INF-g\] and tumor necrosis factor-alpha \[TNF-α\].

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=129 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=44 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=122 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=40 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4 All doubles, Day 0 [N=129,44,122,40]	393.71 Cells Standard Deviation 590.66	494.27 Cells Standard Deviation 518.93	495.77 Cells Standard Deviation 606.84	545.37 Cells Standard Deviation 820.30
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-CD40L, Day 0 [N=129,44,122,40]	388.69 Cells Standard Deviation 571.91	461.29 Cells Standard Deviation 513.70	485.71 Cells Standard Deviation 594.88	540.73 Cells Standard Deviation 771.32
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-IL-2, Day 0 [N=129,44,122,40]	376.03 Cells Standard Deviation 545.75	448.43 Cells Standard Deviation 500.03	461.23 Cells Standard Deviation 552.91	510.47 Cells Standard Deviation 700.70
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-INF-g, Day 0 [N=129,44,122,40]	270.99 Cells Standard Deviation 500.13	322.17 Cells Standard Deviation 349.01	343.35 Cells Standard Deviation 549.24	371.67 Cells Standard Deviation 695.33
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-TNF-a, Day 0 [N=129,44,122,40]	310.91 Cells Standard Deviation 486.27	369.54 Cells Standard Deviation 427.12	358.27 Cells Standard Deviation 538.07	382.79 Cells Standard Deviation 641.28
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4 All doubles, Day 21 [N=112,42,110,34]	1407.29 Cells Standard Deviation 1354.44	943.54 Cells Standard Deviation 1034.54	1793.92 Cells Standard Deviation 1867.92	1284.19 Cells Standard Deviation 1058.55
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-CD40L, Day 21 [N=112,42,110,34]	1374.26 Cells Standard Deviation 1304.02	944.17 Cells Standard Deviation 1015.89	1731.58 Cells Standard Deviation 1828.74	1230.48 Cells Standard Deviation 989.52
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-IL-2, Day 21 [N=112,42,110,34]	1318.03 Cells Standard Deviation 1250.79	868.24 Cells Standard Deviation 967.47	1651.88 Cells Standard Deviation 1776.72	1178.95 Cells Standard Deviation 1001.08
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-INF-g, Day 21 [N=112,42,110,34]	685.44 Cells Standard Deviation 884.75	579.45 Cells Standard Deviation 828.17	997.15 Cells Standard Deviation 1023.96	852.75 Cells Standard Deviation 823.22
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-TNF-a, Day 21 [N=112,42,110,34]	932.64 Cells Standard Deviation 974.72	708.15 Cells Standard Deviation 915.15	1207.95 Cells Standard Deviation 1527.86	910.69 Cells Standard Deviation 861.04
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4 All doubles, Day 42 [N=120,43,118,30]	2260.19 Cells Standard Deviation 2242.14	920.9 Cells Standard Deviation 745.36	3049.03 Cells Standard Deviation 4208.17	1316.8 Cells Standard Deviation 1060.97
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-CD40L, Day 42 [N=120,43,118,30]	2198.66 Cells Standard Deviation 2165.46	944.59 Cells Standard Deviation 728.39	2971.34 Cells Standard Deviation 4076.52	1254.99 Cells Standard Deviation 974.2
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-IL-2, Day 42 [N=120,43,118,30]	2086.84 Cells Standard Deviation 2086.66	854.9 Cells Standard Deviation 727.62	2762.65 Cells Standard Deviation 3720.42	1242.26 Cells Standard Deviation 976.18
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-INF-g, Day 42 [N=120,43,118,30]	1123.16 Cells Standard Deviation 1356.18	671.86 Cells Standard Deviation 552.02	1535.37 Cells Standard Deviation 2864.48	828.99 Cells Standard Deviation 732.58
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD4-TNF-a, Day 42 [N=120,43,118,30]	1595.64 Cells Standard Deviation 1798.95	701.35 Cells Standard Deviation 691.26	2170.46 Cells Standard Deviation 3380.48	918.5 Cells Standard Deviation 822.2
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8 All doubles, Day 0 [N=129,44,121,40]	83.30 Cells Standard Deviation 407.94	52.25 Cells Standard Deviation 497.68	71.93 Cells Standard Deviation 626.44	94.74 Cells Standard Deviation 1903.91
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-CD40L, Day 0 [N=129,44,121,40]	3.37 Cells Standard Deviation 52.35	2.94 Cells Standard Deviation 34.07	3.58 Cells Standard Deviation 48.88	4.30 Cells Standard Deviation 322.83
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-IL-2, Day 0 [N=129,44,121,40]	53.90 Cells Standard Deviation 241.03	43.45 Cells Standard Deviation 334.22	59.70 Cells Standard Deviation 340.60	56.29 Cells Standard Deviation 1426.27
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-INF-g, Day 0 [N=129,44,121,40]	83.14 Cells Standard Deviation 394.32	44.71 Cells Standard Deviation 489.55	80.54 Cells Standard Deviation 618.55	98.30 Cells Standard Deviation 1888.61
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-TNF-a, Day 0 [N=129,44,121,40]	63.19 Cells Standard Deviation 355.75	36.83 Cells Standard Deviation 414.08	45.34 Cells Standard Deviation 573.91	82.77 Cells Standard Deviation 1532.47
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8 All doubles, Day 21 [N=111,41,109,34]	70.23 Cells Standard Deviation 391.63	80.16 Cells Standard Deviation 643.85	77.7 Cells Standard Deviation 661.43	115.83 Cells Standard Deviation 1790.72
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-CD40L, Day 21 [N=111,41,109,34]	3.9 Cells Standard Deviation 52.29	3.45 Cells Standard Deviation 30.93	5.61 Cells Standard Deviation 34.07	4.86 Cells Standard Deviation 162.75
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-IL-2, Day 21 [N=111,41,109,34]	45.48 Cells Standard Deviation 251.49	57.71 Cells Standard Deviation 422.85	45.97 Cells Standard Deviation 342.71	77.59 Cells Standard Deviation 1217.04
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-INF-g, Day 21 [N=111,41,109,34]	61.44 Cells Standard Deviation 390.6	62.56 Cells Standard Deviation 629.74	55.07 Cells Standard Deviation 661.84	95.39 Cells Standard Deviation 1777.86
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-TNF-a, Day 21 [N=111,41,109,34]	55.42 Cells Standard Deviation 306.06	75.79 Cells Standard Deviation 579.85	63.94 Cells Standard Deviation 609.54	82.29 Cells Standard Deviation 1468.85
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8 All doubles, Day 42 [N=120,43,118,29]	77.73 Cells Standard Deviation 499.25	63.45 Cells Standard Deviation 462.64	79.56 Cells Standard Deviation 765.47	141.31 Cells Standard Deviation 2816.12
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-CD40L, Day 42 [N=120,43,118,29]	5.32 Cells Standard Deviation 100.78	3.51 Cells Standard Deviation 24.09	5.23 Cells Standard Deviation 51.86	3.41 Cells Standard Deviation 253.17
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-IL-2, Day 42 [N=120,43,118,29]	42.77 Cells Standard Deviation 261.13	40.01 Cells Standard Deviation 296.52	50.37 Cells Standard Deviation 413.85	97.06 Cells Standard Deviation 1832.58
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-INF-g, Day 42 [N=120,43,118,29]	55.71 Cells Standard Deviation 506.29	64.19 Cells Standard Deviation 434.7	63.71 Cells Standard Deviation 767.88	119.73 Cells Standard Deviation 2845.99
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. CD8-TNF-a, Day 42 [N=120,43,118,29]	59.51 Cells Standard Deviation 434.37	40.62 Cells Standard Deviation 375.13	59.1 Cells Standard Deviation 689.32	72.24 Cells Standard Deviation 2394.5

SECONDARY outcome

Timeframe: At Day 180

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=132 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=47 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=122 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=41 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD4 All doubles [N=132,47,122,41]	1247.34 Cells Standard Deviation 1000.47	760.03 Cells Standard Deviation 637.84	1515.07 Cells Standard Deviation 1982.71	850.48 Cells Standard Deviation 764.04
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD4-CD40L [N=132,47,122,41]	1188.86 Cells Standard Deviation 939.31	729.72 Cells Standard Deviation 583.83	1455.68 Cells Standard Deviation 1789.27	808.25 Cells Standard Deviation 678.83
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD4-IL-2 [N=132,47,122,41]	1172.16 Cells Standard Deviation 957.55	704.32 Cells Standard Deviation 596.04	1433.08 Cells Standard Deviation 1921.82	774.93 Cells Standard Deviation 742.9
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD4-INF-g [N=132,47,122,41]	654.11 Cells Standard Deviation 661.08	461.8 Cells Standard Deviation 494.66	763.06 Cells Standard Deviation 1243.6	558.99 Cells Standard Deviation 654.35
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD4-TNF-a [N=132,47,122,41]	937.82 Cells Standard Deviation 839.91	585.7 Cells Standard Deviation 578.22	1143.69 Cells Standard Deviation 1444.11	636 Cells Standard Deviation 713.19
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD8 All doubles [N=132,47,121,41]	32.11 Cells Standard Deviation 293.81	23.66 Cells Standard Deviation 370.71	41.28 Cells Standard Deviation 753.94	36.77 Cells Standard Deviation 685.05
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD8-CD40L [N=132,47,121,41]	2.04 Cells Standard Deviation 26.32	1.93 Cells Standard Deviation 31.43	2.47 Cells Standard Deviation 499.31	1.8 Cells Standard Deviation 23.59
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD8-IL-2 [N=132,47,121,41]	18.78 Cells Standard Deviation 178.46	18.86 Cells Standard Deviation 269.95	23.7 Cells Standard Deviation 704.78	18.95 Cells Standard Deviation 465.37
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD8-INF-g [N=132,47,121,41]	26.37 Cells Standard Deviation 288.43	28.27 Cells Standard Deviation 365.36	41.21 Cells Standard Deviation 663.4	28.29 Cells Standard Deviation 688.23
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells CD8-TNF-a [N=132,47,121,41]	22.3 Cells Standard Deviation 270.88	20.94 Cells Standard Deviation 289.74	36.68 Cells Standard Deviation 390.84	40.55 Cells Standard Deviation 588.74

SECONDARY outcome

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

Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.

Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1562902A 1 Group n=164 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=61 Participants Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=159 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=51 Participants Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	2 Subjects	2 Subjects	6 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	1 Subjects	1 Subjects	8 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Arthralgia	13 Subjects	5 Subjects	13 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Arthralgia	1 Subjects	0 Subjects	2 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Arthralgia	0 Subjects	1 Subjects	2 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Fatigue	32 Subjects	7 Subjects	39 Subjects	6 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Fever (Axillary) >38.0°C	2 Subjects	1 Subjects	5 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Fever (Axillary) ≥39.0°C	1 Subjects	1 Subjects	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fever	0 Subjects	1 Subjects	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Headache	27 Subjects	6 Subjects	34 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	0 Subjects	1 Subjects	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache	2 Subjects	3 Subjects	6 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Myalgia	24 Subjects	5 Subjects	28 Subjects	3 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia	1 Subjects	0 Subjects	4 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia	2 Subjects	1 Subjects	4 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Shivering	2 Subjects	3 Subjects	9 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering	1 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Shivering	0 Subjects	2 Subjects	2 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Sweating	16 Subjects	8 Subjects	19 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Sweating	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Sweating	0 Subjects	1 Subjects	1 Subjects	0 Subjects

Adverse Events

GSK1562902A 1 Group

Serious events: 19 serious events

Other events: 69 other events

Deaths: 0 deaths

GSK1562902A 2 Group

Serious events: 11 serious events

Other events: 8 other events

Deaths: 2 deaths

GSK1562902A 3 Group

Serious events: 16 serious events

Other events: 75 other events

Deaths: 3 deaths

GSK1562902A 4 Group

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1562902A 1 Group n=164 participants at risk；n=165 participants at risk Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 2 Group n=61 participants at risk Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.	GSK1562902A 3 Group n=159 participants at risk Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.	GSK1562902A 4 Group n=51 participants at risk；n=52 participants at risk Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
General disorders Pain	42.1% 69/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	9.8% 6/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	47.2% 75/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	5.9% 3/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Induration	6.1% 10/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	9.4% 15/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Redness	11.6% 19/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	18.9% 30/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	2.0% 1/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Swelling	11.6% 19/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	9.4% 15/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	0.00% 0/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Arthralgia	7.9% 13/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	8.2% 5/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	8.2% 13/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	2.0% 1/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Fatigue	19.5% 32/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	11.5% 7/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	24.5% 39/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	11.8% 6/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Headache	16.5% 27/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	9.8% 6/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	21.4% 34/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	3.9% 2/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Myalgia	14.6% 24/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	8.2% 5/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	17.6% 28/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	5.9% 3/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Shivering	1.2% 2/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	4.9% 3/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	5.7% 9/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	3.9% 2/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
General disorders Sweating	9.8% 16/164 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	13.1% 8/61 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	11.9% 19/159 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.	3.9% 2/51 • Unsolicited AEs were collected within 21/30 days after the first/second vaccination. Solicited AEs were collected within 7 days after each vaccination. SAEs were collected for the entire study period (Day 0-Mth 24) within 4 timeframes: Days 0-51, Day 52-Month 6, Months 6-12 and Months 12-24. No unsolicited AEs with a frequency of >5% were reported (the number of participants at risk in the Other AE section is therefore the number of participants at risk analysed for the solicited AEs reporting) For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.

Additional Information

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