Trial Outcomes & Findings for Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults (NCT NCT00968539)

Last Updated: 2019-11-18

Results Overview

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

130 participants

Primary outcome timeframe

At Day 42

Results posted on

2019-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	GSK2340272A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Overall Study STARTED	64	66
Overall Study COMPLETED	63	66
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2340272A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Overall Study Lost to follow-up (incompl. vaccination)	1	0

Baseline Characteristics

Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2340272A Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Total n=130 Participants Total of all reporting groups
Age, Continuous	39.1 Years STANDARD_DEVIATION 13.53 • n=5 Participants	38.2 Years STANDARD_DEVIATION 14.10 • n=7 Participants	38.64 Years STANDARD_DEVIATION 13.78 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	39 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Asian-East Asian heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	64 Participants n=5 Participants	65 Participants n=7 Participants	129 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies	58 Participants	—

PRIMARY outcome

Timeframe: At Day 42

A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroprotected Subjects for HI Antibodies	59 Participants	—

PRIMARY outcome

Timeframe: At Day 42

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	72.9 Fold increase Interval 55.4 to 95.9	—

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/7/09.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=60 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Flu A/CAL/7/09, Day 42	59 Participants	66 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Flu A/CAL/7/09, Day 0	23 Participants	28 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Flu A/CAL/7/09, Day 21	60 Participants	65 Participants

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.

Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/7/09.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value	59 Participants	61 Participants

SECONDARY outcome

Timeframe: At Day 364

Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects who met all eligibility criteria and for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.

Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/09.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value	59 Participants	62 Participants

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=60 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 0	8.8 Titers Interval 7.0 to 11.1	10.8 Titers Interval 8.1 to 14.4
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 21	335.2 Titers Interval 250.1 to 449.2	310.2 Titers Interval 218.8 to 439.7
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 42	636.3 Titers Interval 520.9 to 777.3	341.0 Titers Interval 259.9 to 447.3

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects who met all eligibility criteria and for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	204.8 Titers Interval 161.5 to 259.8	146.1 Titers Interval 108.5 to 196.7

SECONDARY outcome

Timeframe: At Day 364

Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	85.8 Titers Interval 64.4 to 114.3	87.6 Titers Interval 64.7 to 118.8

SECONDARY outcome

Timeframe: At Day 21

Seroconversion was defined as: For initially seronegative subjects (antibody titer \< 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=60 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted Subjects for HI Antibodies	59 Participants	56 Participants

SECONDARY outcome

Timeframe: At Day 42

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted Subjects for HI Antibodies	61 Participants	—

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted Subjects for HI Antibodies	57 Participants	47 Participants

SECONDARY outcome

Timeframe: At Day 364

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted Subjects for HI Antibodies	41 Participants	46 Participants

SECONDARY outcome

Timeframe: At Days 0 and 21

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=60 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroprotected Subjects for HI Antibodies Flu A/CAL/7/09, Day 0	7 Participants	12 Participants
Number of Seroprotected Subjects for HI Antibodies Flu A/CAL/7/09, Day 21	60 Participants	62 Participants

SECONDARY outcome

Timeframe: At Day 42

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroprotected Subjects for HI Antibodies	66 Participants	—

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroprotected Subjects for HI Antibodies	59 Participants	52 Participants

SECONDARY outcome

Timeframe: At Day 364

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroprotected Subjects for HI Antibodies	46 Participants	55 Participants

SECONDARY outcome

Timeframe: At Day 21

Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=60 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	38.1 Fold increase Interval 28.6 to 50.7	28.7 Fold increase Interval 20.0 to 41.2

SECONDARY outcome

Timeframe: At Day 42

Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	31.5 Fold increase Interval 23.1 to 43.2	—

SECONDARY outcome

Timeframe: At Day 182

Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	22.5 Fold increase Interval 18.0 to 28.2	13.9 Fold increase Interval 10.2 to 18.9

SECONDARY outcome

Timeframe: At Day 364

Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	9.7 Fold increase Interval 7.4 to 12.5	8.3 Fold increase Interval 6.2 to 11.0

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=28 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=30 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09, Day 0	6.1 Titers Interval 4.6 to 8.0	9.6 Titers Interval 6.7 to 13.6
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09, Day 21	152.3 Titers Interval 78.4 to 295.9	89.9 Titers Interval 51.6 to 156.6
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09, Day 42	243.8 Titers Interval 163.4 to 363.7	144.9 Titers Interval 88.7 to 236.6

SECONDARY outcome

Timeframe: At Days 21 and 42

Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=28 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=30 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Flu A/Neth/602/09, Day 21	21 Participants	22 Participants
Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Flu A/Neth/602/09, Day 42	27 Participants	23 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

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

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.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	57 Participants	23 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	5 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	56 Participants	20 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	3 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	9 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across Doses	61 Participants	32 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across Doses	3 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across Doses	4 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across Doses	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across Doses	11 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across Doses	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with the symptom sheet filled in.

The number of days with any solicited local symptoms reported during the solicited post-vaccination period. There were no subjects from GSK2340269A Group who reported Redness or Swelling.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=113 Doses with the symptom Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=43 Doses with the symptom Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Days With Solicited Local Symptoms Pain, post-Dose 2	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited Local Symptoms Pain, Overall/dose	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited Local Symptoms Redness, post-Dose 1	3.0 Days Interval 3.0 to 3.0	—
Number of Days With Solicited Local Symptoms Pain, post-Dose 1	3.0 Days Interval 2.0 to 4.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited Local Symptoms Redness, post-Dose 2	2.0 Days Interval 2.0 to 3.0	—
Number of Days With Solicited Local Symptoms Redness, Overall/dose	2.5 Days Interval 2.0 to 3.0	—
Number of Days With Solicited Local Symptoms Swelling, post-Dose 1	2.0 Days Interval 2.0 to 2.0	—
Number of Days With Solicited Local Symptoms Swelling, post-Dose 2	2.0 Days Interval 2.0 to 2.0	—
Number of Days With Solicited Local Symptoms Swelling, Overall/dose	2.0 Days Interval 2.0 to 2.0	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

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

Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever \[defined as axillary temperature equal to or above ≥ 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	22 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	21 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	17 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	22 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	20 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 2	13 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 2	13 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	23 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	23 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	11 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	11 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	34 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	29 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Across doses	14 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Across doses	14 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	27 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	27 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	14 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	15 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 1	7 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 1	7 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	20 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	20 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	6 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	6 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	6 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	6 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	28 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	27 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	12 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	12 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	33 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	27 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	14 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	14 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	14 Participants	9 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

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

The number of days with any solicited general symptoms reported during the solicited post-vaccination period. There were no subjects from GSK2340269A Group who reported Temperature.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=50 Doses with the symptom Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=31 Doses with the symptom Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Days With Solicited General Symptoms Fatigue, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Fatigue, post-Dose 2	1.5 Days Interval 1.0 to 3.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited General Symptoms Fatigue, Overall/dose	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Sweating, post-Dose 2	1.5 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Headache, post-Dose 1	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Headache, post-Dose 2	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 2.0 to 3.0
Number of Days With Solicited General Symptoms Headache, Overall/dose	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Joint pain, post-Dose 1	3.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.5 to 3.0
Number of Days With Solicited General Symptoms Joint pain, post-Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.5
Number of Days With Solicited General Symptoms Joint pain, Overall/dose	1.5 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.5
Number of Days With Solicited General Symptoms Muscle aches, post-Dose 1	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Muscle aches, post-Dose 2	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Muscle aches, Overall/dose	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Sweating, post-Dose 1	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Sweating, Overall/dose	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Shivering, post-Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Shivering, post-Dose 2	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Shivering, Overall/dose	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Temperature, post-Dose 2	2.0 Days Interval 2.0 to 2.0	—
Number of Days With Solicited General Symptoms Temperature, Overall/dose	2.0 Days Interval 2.0 to 2.0	—

SECONDARY outcome

Timeframe: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 83)

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

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	GSK2340272A Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	39 Participants	38 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	7 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	12 Participants	7 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Day 364)

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

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.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Adverse Events of Specific Interest (AESIs)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Day 364)

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

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants	1 Participants

Adverse Events

GSK2340272A Group

Serious events: 2 serious events

Other events: 62 other events

Deaths: 0 deaths

GSK2340269A Group

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK2340272A Group n=64 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Nervous system disorders Migraine	0.00% 0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	1.5% 1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	1.6% 1/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.6% 1/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER

Measure	GSK2340272A Group n=64 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340269A Group n=66 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
General disorders Pain	96.8% 61/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	48.5% 32/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Redness	6.3% 4/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Swelling	17.5% 11/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Fatigue	54.0% 34/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	33.3% 22/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Headache	46.0% 29/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	21.2% 14/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Joint pain	22.2% 14/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	9.1% 6/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Muscle aches	42.9% 27/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	18.2% 12/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Shivering	22.2% 14/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	9.1% 6/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Sweating	22.2% 14/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	16.7% 11/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Infections and infestations Upper respiratory tract infection	9.4% 6/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	16.7% 11/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Nervous system disorders Headache	10.9% 7/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	10.6% 7/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Infections and infestations Rhinitis	15.6% 10/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	4.5% 3/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Influenza like illness	6.2% 4/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	9.1% 6/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Gastrointestinal disorders Nausea	6.2% 4/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	3.0% 2/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 4/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	3.0% 2/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.