Trial Outcomes & Findings for Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older (NCT NCT00979602)

Last Updated: 2018-03-21

Results Overview

A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4048 participants

Primary outcome timeframe

At Day 21

Results posted on

2018-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	GSK2340274A Group Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A Group Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Study STARTED	2025	2023
Overall Study COMPLETED	1880	1890
Overall Study NOT COMPLETED	145	133

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2340274A Group Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A Group Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Study Serious Adverse Event	5	3
Overall Study Protocol Violation	3	0
Overall Study Withdrawal by Subject	31	25
Overall Study Lost to Follow-up	100	96
Overall Study Migrated/moved from study area	3	6
Overall Study Others	3	3

Baseline Characteristics

Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2340274A Group n=2025 Participants Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A Group n=2023 Participants Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Total n=4048 Participants Total of all reporting groups
Age, Continuous	45.5 Years STANDARD_DEVIATION 18.6 • n=5 Participants	45.4 Years STANDARD_DEVIATION 18.3 • n=7 Participants	45.5 Years STANDARD_DEVIATION 18.4 • n=5 Participants
Sex: Female, Male Female	1185 Participants n=5 Participants	1185 Participants n=7 Participants	2370 Participants n=5 Participants
Sex: Female, Male Male	840 Participants n=5 Participants	838 Participants n=7 Participants	1678 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage/African American	118 Participants n=5 Participants	113 Participants n=7 Participants	231 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan native	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian Heritage	35 Participants n=5 Participants	42 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian Heritage	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Japanese Heritage	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian Heritage	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic/North African Heritage	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian/European Heritage	1787 Participants n=5 Participants	1790 Participants n=7 Participants	3577 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Other	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1345 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=535 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1338 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=531 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1426 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=454 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1414 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=455 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain	1210 Participants	411 Participants	1012 Participants	301 Participants	1279 Participants	342 Participants	1055 Participants	258 Participants

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1347 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=535 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1344 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=532 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1428 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=454 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1420 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=456 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain	337 Participants	74 Participants	332 Participants	92 Participants	350 Participants	61 Participants	346 Participants	78 Participants

PRIMARY outcome

Timeframe: At Day 21

A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1350 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=539 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1347 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=533 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1432 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=457 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1424 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=456 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain	1326 Participants	470 Participants	1246 Participants	371 Participants	1403 Participants	393 Participants	1302 Participants	315 Participants

PRIMARY outcome

Timeframe: At Day 21

SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1345 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=535 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1338 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=531 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1426 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=454 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1414 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=455 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain	27.7 Fold increase Interval 25.7 to 29.9	12.5 Fold increase Interval 11.2 to 13.9	15.5 Fold increase Interval 14.2 to 16.8	6.4 Fold increase Interval 5.7 to 7.1	26.9 Fold increase Interval 25.0 to 29.0	11.9 Fold increase Interval 10.5 to 13.4	14.8 Fold increase Interval 13.6 to 16.1	6.3 Fold increase Interval 5.5 to 7.1

PRIMARY outcome

Timeframe: From Day 14 post-vaccination up to study end (at Day 385)

Population: The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.

The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1949 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=1958 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases	1 Events	2 Events	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 21

Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1350 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=539 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1347 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=533 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1432 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=457 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1424 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=456 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain Flu A/CAL/7/09, Day 0	754 Participants	293 Participants	731 Participants	312 Participants	803 Participants	244 Participants	775 Participants	268 Participants
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain Flu A/CAL/7/09, Day 21	1348 Participants	534 Participants	1335 Participants	512 Participants	1430 Participants	452 Participants	1410 Participants	437 Participants

SECONDARY outcome

Timeframe: At Days 0 and 21

Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1350 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=539 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1347 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=533 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1432 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=457 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1424 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=456 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain Flu A/CAL/7/09, Day 0	14.9 Titers Interval 13.9 to 16.0	11.0 Titers Interval 10.1 to 11.9	14.8 Titers Interval 13.8 to 15.8	12.2 Titers Interval 11.2 to 13.3	14.7 Titers Interval 13.8 to 15.7	10.9 Titers Interval 10.0 to 11.9	14.7 Titers Interval 13.7 to 15.7	12.0 Titers Interval 11.0 to 13.2
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain Flu A/CAL/7/09, Day 21	415.0 Titers Interval 391.4 to 440.0	135.9 Titers Interval 122.1 to 151.1	228.7 Titers Interval 213.5 to 245.0	77.3 Titers Interval 68.4 to 87.4	396.2 Titers Interval 373.8 to 419.9	128.6 Titers Interval 114.6 to 144.3	217.6 Titers Interval 203.3 to 232.9	75.2 Titers Interval 65.9 to 85.9

SECONDARY outcome

Timeframe: At Day 42

Population: The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.

Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=50 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=50 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=44 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=48 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=52 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=48 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=46 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=46 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain	50 Participants	50 Participants	44 Participants	45 Participants	52 Participants	48 Participants	46 Participants	43 Participants

SECONDARY outcome

Timeframe: At Day 42

Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=50 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=50 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=44 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=48 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=52 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=48 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=46 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=46 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain	288.5 Titers Interval 215.9 to 385.5	105.4 Titers Interval 70.8 to 157.0	177.2 Titers Interval 121.3 to 259.0	47.9 Titers Interval 33.1 to 69.2	276.5 Titers Interval 207.1 to 369.0	105.9 Titers Interval 70.2 to 159.9	170.0 Titers Interval 117.7 to 245.4	47.2 Titers Interval 32.1 to 69.3

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.

Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1306 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=543 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1314 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=536 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1388 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=461 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1391 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=459 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain	1282 Participants	501 Participants	1257 Participants	449 Participants	1361 Participants	422 Participants	1324 Participants	382 Participants

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1306 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=543 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1314 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=536 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1388 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=461 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1391 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=459 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain	115.5 Titers Interval 107.8 to 123.7	38.4 Titers Interval 34.6 to 42.6	87.6 Titers Interval 81.4 to 94.3	30.1 Titers Interval 26.9 to 33.6	109.5 Titers Interval 102.3 to 117.1	37.1 Titers Interval 33.2 to 41.5	83.3 Titers Interval 77.5 to 89.5	29.2 Titers Interval 26.0 to 33.0

SECONDARY outcome

Timeframe: At Day 42

A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=50 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=50 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=44 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=48 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=52 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=48 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=46 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=46 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain	49 Participants	36 Participants	35 Participants	20 Participants	51 Participants	34 Participants	36 Participants	19 Participants

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1302 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=539 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1304 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=534 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1383 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=458 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1380 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=458 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain	823 Participants	198 Participants	717 Participants	146 Participants	861 Participants	160 Participants	741 Participants	122 Participants

SECONDARY outcome

Timeframe: At Day 42

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=50 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=50 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=44 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=48 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=52 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=48 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=46 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=46 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain	49 Participants	38 Participants	41 Participants	29 Participants	51 Participants	36 Participants	43 Participants	27 Participants

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1306 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=543 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1314 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=536 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1388 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=461 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1391 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=459 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain	1091 Participants	286 Participants	1009 Participants	236 Participants	1140 Participants	237 Participants	1047 Participants	198 Participants

SECONDARY outcome

Timeframe: At Day 42

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=50 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=50 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=44 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=48 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=52 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=48 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=46 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=46 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain	26.8 Fold increase Interval 20.0 to 35.8	11.1 Fold increase Interval 7.7 to 16.0	13.7 Fold increase Interval 9.1 to 20.6	4.0 Fold increase Interval 2.9 to 5.5	26.1 Fold increase Interval 19.7 to 34.6	11.0 Fold increase Interval 7.5 to 16.1	13.2 Fold increase Interval 8.8 to 19.7	3.9 Fold increase Interval 2.9 to 5.4

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1302 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=539 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1304 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=534 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group n=1383 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group n=458 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group n=1380 Participants Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group n=458 Participants Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain	7.7 Fold increase Interval 7.2 to 8.4	3.5 Fold increase Interval 3.2 to 3.9	5.9 Fold increase Interval 5.4 to 6.4	2.5 Fold increase Interval 2.3 to 2.8	7.5 Fold increase Interval 6.9 to 8.1	3.4 Fold increase Interval 3.0 to 3.8	5.6 Fold increase Interval 5.2 to 6.1	2.5 Fold increase Interval 2.2 to 2.8

SECONDARY outcome

Timeframe: From Day 0 up to the end of ILI surveillance (Day 385)

Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1949 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=1958 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of A/California Influenza Related Cases ILI cases	195 Events	234 Events	—	—	—	—	—	—
Number of A/California Influenza Related Cases Pneumonia cases	8 Events	21 Events	—	—	—	—	—	—
Number of A/California Influenza Related Cases RT-qPCR confirmed influenza	1 Events	2 Events	—	—	—	—	—	—
Number of A/California Influenza Related Cases Culture confirmed influenza	1 Events	2 Events	—	—	—	—	—	—
Number of A/California Influenza Related Cases RT-qPCR confirmed influenza with pneumonia	0 Events	0 Events	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 up to the end of ILI surveillance (Day 385)

Assessed ILI symptoms were fever \[defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)\], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1949 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=1958 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of ILI Symptoms in All Reported ILI Cases Fever	47 Events	58 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Myalgia	109 Events	140 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Cough	104 Events	138 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Sore throat	98 Events	140 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Runny or stuffy nose	103 Events	132 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Short of breath	48 Events	54 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Headache	97 Events	134 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Vomiting	23 Events	20 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Diarrhea	30 Events	35 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Chills	80 Events	104 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Fatigue	106 Events	146 Events	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 14 post-vaccination through the end of ILI surveillance (Day 385)

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1949 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=1958 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of ILI Symptoms in All Reported ILI Cases Fatigue	102 Events	132 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Vomiting	21 Events	16 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Diarrhea	28 Events	32 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Fever	45 Events	51 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Myalgia	104 Events	128 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Cough	99 Events	127 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Sore throat	93 Events	129 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Runny or stuffy nose	99 Events	119 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Short of breath	46 Events	50 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Headache	93 Events	122 Events	—	—	—	—	—	—
Number of ILI Symptoms in All Reported ILI Cases Chills	76 Events	96 Events	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y).

Outcome measures

Outcome measures
Measure	GSK2340274A (18-60 y) Group n=1529 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>60 y) Group n=480 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-60 y) Group n=1531 Participants Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>60 y) Group n=479 Participants Healthy male or female subjects older than 60 years of age (\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340274A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (18-64 y) Group Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	GSK2340273A (>64 y) Group Healthy male or female subjects older than 64 years of age (\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	55 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	1256 Participants	272 Participants	458 Participants	45 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	89 Participants	25 Participants	11 Participants	6 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	137 Participants	28 Participants	10 Participants	3 Participants	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.

Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\], headache, joint pain at other location, muscle aches, 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. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\>64y).