Trial Outcomes & Findings for Study to Evaluate Immunogenicity & Safety of an Investigational Influenza Vaccine in Adults (NCT NCT00975884)

NCT ID: NCT00975884

Last Updated: 2019-03-18

Results Overview

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], 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). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 312 participants
• Primary outcome timeframe: At Day 21
• Results posted on: 2019-03-18

Participant Flow

Out of 313 subjects enrolled in the study, 7 subjects did not receive any vaccination.

Participant milestones

Measure	GSK2340272A (D21) GROUP Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 (D21).	GSK2340272A (M6) GROUP Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 Month 6 (M6).
Overall Study STARTED	184	122
Overall Study COMPLETED	168	107
Overall Study NOT COMPLETED	16	15

Reasons for withdrawal

Measure	GSK2340272A (D21) GROUP Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 (D21).	GSK2340272A (M6) GROUP Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 Month 6 (M6).
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	5	3
Overall Study Withdrawal by Subject	9	9
Overall Study Other	1	3

Baseline Characteristics

Study to Evaluate Immunogenicity & Safety of an Investigational Influenza Vaccine in Adults

Baseline characteristics by cohort

Measure	GSK2340272A (D21) GROUP n=184 Participants Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 (D21).	GSK2340272A (M6) GROUP n=122 Participants Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 Month 6 (M6).	Total n=306 Participants Total of all reporting groups
Age, Continuous	52.8 Years STANDARD_DEVIATION 16.8 • n=5 Participants	51.6 Years STANDARD_DEVIATION 16.0 • n=7 Participants	52.3 Years STANDARD_DEVIATION 16.5 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	63 Participants n=7 Participants	155 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	59 Participants n=7 Participants	151 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage / African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian Heritage	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic / North African Heritage	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian / European Heritage	174 Participants n=5 Participants	114 Participants n=7 Participants	288 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 21

Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post 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). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=160 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=136 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies	154 Participants	121 Participants	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=160 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=136 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain	156 Participants	125 Participants	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post 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). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=160 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=136 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Percentage of Seroconverted (SCR) Subjects for HI Antibodies	96.3 Percentage of subjects Interval 92.0 to 98.6	89.0 Percentage of subjects Interval 82.5 to 93.7	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.

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. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=160 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=136 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	45.0 Ratio Interval 37.2 to 54.5	23.4 Ratio Interval 19.1 to 28.7	—	—

SECONDARY outcome

Timeframe: At Day 0, 21 and 42

Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

Titres 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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=87 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=83 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=67 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=48 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease Flu A/CAL/7/2009, Day 0	8.9 Titers Interval 7.2 to 11.0	7.3 Titers Interval 6.3 to 8.5	9.3 Titers Interval 7.4 to 11.8	8.0 Titers Interval 6.6 to 9.8
Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease Flu A/CAL/7/2009, Day 21	459.8 Titers Interval 374.2 to 565.1	168.2 Titers Interval 129.0 to 219.3	366.1 Titers Interval 266.7 to 502.7	187.5 Titers Interval 136.6 to 257.4
Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease Flu A/CAL/7/2009, Day 42	771.8 Titers Interval 660.5 to 901.7	400.9 Titers Interval 329.3 to 488.2	297.6 Titers Interval 218.6 to 405.2	132.6 Titers Interval 94.3 to 186.6

SECONDARY outcome

Timeframe: At Day 182

Population: The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for 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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=85 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=83 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=56 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=30 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease	240.5 Titers Interval 193.6 to 298.8	97.8 Titers Interval 79.4 to 120.4	124.1 Titers Interval 88.1 to 174.8	48.6 Titers Interval 30.0 to 78.9

SECONDARY outcome

Timeframe: At Day 203

Population: The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.

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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=48 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=28 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease	708.3 Titers Interval 546.2 to 918.5	512.1 Titers Interval 354.5 to 740.0	—	—

SECONDARY outcome

Timeframe: At Day 364

Population: The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.

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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=79 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=76 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=46 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	107.8 Titers Interval 82.9 to 140.1	35.8 Titers Interval 28.0 to 45.7	155.5 Titers Interval 116.8 to 207.0	68.8 Titers Interval 51.2 to 92.5

SECONDARY outcome

Timeframe: At Day 21 and 42

Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post 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). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=87 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=83 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=67 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=48 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Seroconverted (SCR) Subjects for HI Antibodies Flu A/CAL/7/2009, Day 21	87 Participants	74 Participants	62 Participants	43 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies Flu A/CAL/7/2009, Day 42	86 Participants	82 Participants	61 Participants	39 Participants

SECONDARY outcome

Timeframe: At Day 182

Population: The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post 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). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=85 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=83 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=56 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=30 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Seroconverted (SCR) Subjects for HI Antibodies	79 Participants	72 Participants	47 Participants	17 Participants

SECONDARY outcome

Timeframe: At Day 203

Population: The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post 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). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=48 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=28 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Seroconverted (SCR) Subjects for HI Antibodies	48 Participants	28 Participants	—	—

SECONDARY outcome

Timeframe: At Day 364

Population: The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post 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). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=79 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=76 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=46 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Seroconverted (SCR) Subjects for HI Antibodies	60 Participants	31 Participants	54 Participants	34 Participants

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=87 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=83 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=67 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=48 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 0	11 Participants	6 Participants	10 Participants	1 Participants
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 21	87 Participants	75 Participants	63 Participants	46 Participants
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 42	87 Participants	83 Participants	64 Participants	43 Participants

SECONDARY outcome

Timeframe: At Day 182

Population: The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=85 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=83 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=56 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=30 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain	83 Participants	75 Participants	48 Participants	19 Participants

SECONDARY outcome

Timeframe: At Day 203

Population: The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=48 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=28 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain	48 Participants	28 Participants	—	—

SECONDARY outcome

Timeframe: At Day 364

Population: The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.

A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=79 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=76 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=46 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain	65 Participants	38 Participants	56 Participants	37 Participants

SECONDARY outcome

Timeframe: At Day 21 and 42

Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

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. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=87 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=83 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=67 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=48 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 21	51.6 Ratio Interval 40.7 to 65.5	23.0 Ratio Interval 17.7 to 29.9	39.2 Ratio Interval 28.3 to 54.2	23.3 Ratio Interval 16.6 to 32.7
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 42	86.7 Ratio Interval 68.6 to 109.5	54.9 Ratio Interval 43.4 to 69.3	31.9 Ratio Interval 23.4 to 43.4	16.5 Ratio Interval 11.8 to 23.0

SECONDARY outcome

Timeframe: At Day 182

Population: The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.

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. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=85 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=83 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=56 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=30 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	26.6 Ratio Interval 20.8 to 34.0	13.4 Ratio Interval 10.9 to 16.5	14.6 Ratio Interval 10.8 to 19.7	6.1 Ratio Interval 3.9 to 9.4

SECONDARY outcome

Timeframe: At Day 203

Population: The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.

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. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=48 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=28 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	79.0 Ratio Interval 58.0 to 107.7	65.7 Ratio Interval 41.4 to 104.1	—	—

SECONDARY outcome

Timeframe: At Day 364

Population: The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.

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. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=79 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=76 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=46 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	11.9 Ratio Interval 9.2 to 15.5	4.8 Ratio Interval 3.8 to 6.1	17.3 Ratio Interval 13.0 to 23.0	8.3 Ratio Interval 6.0 to 11.3

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=24 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=24 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=19 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=18 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease Flu A/Netherlands/602/09, Day 0	6.0 Titers Interval 4.2 to 8.6	10.2 Titers Interval 7.0 to 14.8	5.5 Titers Interval 4.1 to 7.4	17.9 Titers Interval 11.3 to 28.5
Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease Flu A/Netherlands/602/09, Day 21	163.0 Titers Interval 84.3 to 315.2	96.4 Titers Interval 56.0 to 166.1	164.2 Titers Interval 64.0 to 420.7	168.3 Titers Interval 86.3 to 328.3
Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease Flu A/Netherlands/602/09, Day 42	408.2 Titers Interval 257.0 to 648.4	207.8 Titers Interval 136.0 to 317.4	165.3 Titers Interval 70.7 to 386.1	105.0 Titers Interval 58.3 to 189.3

SECONDARY outcome

Timeframe: At Day 21 and 42

Population: The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Netherlands/602/09. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=24 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=24 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=19 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=18 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Flu A/Netherlands/602/09, Day 42	100 Percentage of subjects Interval 85.8 to 100.0	87.5 Percentage of subjects Interval 67.6 to 97.3	84.2 Percentage of subjects Interval 60.4 to 96.6	61.1 Percentage of subjects Interval 35.7 to 82.7
Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Flu A/Netherlands/602/09, Day 21	75.0 Percentage of subjects Interval 53.3 to 90.2	62.5 Percentage of subjects Interval 40.6 to 81.2	84.2 Percentage of subjects Interval 60.4 to 96.6	61.1 Percentage of subjects Interval 35.7 to 82.7

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, 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 = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=162 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=142 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	154 Participants	106 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Participants	2 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	18 Participants	9 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	17 Participants	7 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

The number of days with any solicited local symptoms reported during the solicited post-vaccination period.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=154 Doses Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=106 Doses Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses Pain	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	—	—
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses Redness	2.0 Days Interval 2.0 to 4.0	2.0 Days Interval 2.0 to 3.0	—	—
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses Swelling	3.0 Days Interval 2.0 to 3.0	2.0 Days Interval 2.0 to 3.0	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses - Interim Analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, 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 = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=92 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=90 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	87 Participants	71 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	0 Participants	2 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	10 Participants	8 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	11 Participants	6 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	80 Participants	62 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	6 Participants	11 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	8 Participants	10 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	91 Participants	78 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	2 Participants	2 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	14 Participants	17 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	15 Participants	15 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 Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, 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 = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=92 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=90 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	11 Participants	6 Participants	6 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	87 Participants	71 Participants	67 Participants	35 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	10 Participants	8 Participants	8 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	80 Participants	62 Participants	54 Participants	26 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	2 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	6 Participants	11 Participants	6 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	8 Participants	10 Participants	10 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	91 Participants	78 Participants	68 Participants	40 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	2 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	14 Participants	17 Participants	13 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	0 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	15 Participants	15 Participants	13 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

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

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

The number of days with any solicited local symptoms reported during the solicited post-vaccination period.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=87 Doses Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=71 Doses Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=67 Doses 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=35 Doses Healthy male or female adults, \> 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 Month 6 (M6).
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses Pain, post-Dose 1	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 1.0 to 4.0
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses Pain, post-Dose 2	3.0 Days Interval 2.0 to 3.5	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 3.0
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses Redness, post-Dose 1	2.5 Days Interval 1.0 to 4.0	2.0 Days Interval 1.5 to 3.5	2.0 Days Interval 2.0 to 3.5	3.0 Days Interval 3.0 to 3.0
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses Redness, post-Dose 2	2.5 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0	4.0 Days Interval 3.0 to 6.0
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses Swelling, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 3.0	3.0 Days Interval 3.0 to 4.0	6.0 Days Interval 6.0 to 6.0
Duration of Solicited Local Symptoms Occurring in Response to Individual Doses Swelling, post-Dose 2	2.0 Days Interval 1.0 to 3.0	3.0 Days Interval 1.0 to 4.0	2.0 Days Interval 2.0 to 3.0	2.0 Days Interval 1.0 to 4.5

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

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 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=162 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=142 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	56 Participants	34 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	56 Participants	29 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	1 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	43 Participants	23 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain	31 Participants	27 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain	26 Participants	20 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering	22 Participants	11 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches	66 Participants	41 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches	0 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches	56 Participants	35 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering	31 Participants	18 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering	0 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	67 Participants	44 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating	19 Participants	17 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating	13 Participants	9 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature	3 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following first dose - Interim analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administrated documented, who filled in their symptom sheets.

The number of days with any solicited general symptoms reported during the solicited post-vaccination period.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=67 Doses Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=44 Doses Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Sweating	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Fatigue	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Headache	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Joint pain	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Muscle aches	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Shivering	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Temperature	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses - Interim analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.

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 or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=92 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=90 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	40 Participants	26 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	35 Participants	22 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	34 Participants	20 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	0 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	30 Participants	17 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 1	21 Participants	19 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	17 Participants	15 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	43 Participants	26 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	36 Participants	23 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	17 Participants	12 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	13 Participants	8 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	12 Participants	10 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 1	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	9 Participants	6 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	1 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	48 Participants	27 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	3 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	41 Participants	18 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	41 Participants	19 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	1 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	36 Participants	12 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 2	17 Participants	21 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	17 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	38 Participants	25 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	31 Participants	19 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	26 Participants	13 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	1 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	24 Participants	9 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	19 Participants	13 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	17 Participants	8 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	6 Participants	5 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	5 Participants	4 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	59 Participants	39 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	3 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	53 Participants	30 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	53 Participants	30 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	1 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	46 Participants	23 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Across doses	26 Participants	27 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	21 Participants	22 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	53 Participants	34 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	46 Participants	29 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	34 Participants	22 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	1 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	29 Participants	15 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	24 Participants	19 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	2 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	19 Participants	13 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	7 Participants	5 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	0 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	5 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses - Interim analysis posed at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.

The number of days with any solicited general symptoms reported during the solicited post-vaccination period.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=88 Doses Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=53 Doses Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Temperature, post-Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Temperature, Overall/dose	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Fatigue, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Fatigue, post-Dose 2	2.0 Days Interval 1.0 to 2.5	2.0 Days Interval 1.0 to 4.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Fatigue, Overall/dose	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Headache, post-Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.5	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Headache, post-Dose 2	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Headache, Overall/dose	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Joint pain, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Joint pain, post-Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Joint pain, Overall/dose	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.5	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Muscle aches, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Muscle aches, post-Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 3.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Muscle aches, Overall/dose	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Sweating, post-Dose 1	1.5 Days Interval 1.0 to 2.5	2.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Sweating, post-Dose 2	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Sweating, Overall/dose	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Shivering, post-Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.5	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Shivering, post-Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Shivering, Overall/dose	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Temperature, post-Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	—	—

SECONDARY outcome

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

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

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 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=92 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=90 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 1	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	8 Participants	6 Participants	4 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	41 Participants	19 Participants	21 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 2	18 Participants	21 Participants	16 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	32 Participants	19 Participants	28 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	1 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	1 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	40 Participants	26 Participants	27 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	35 Participants	22 Participants	21 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	34 Participants	20 Participants	22 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	29 Participants	17 Participants	13 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 1	21 Participants	19 Participants	10 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 1	17 Participants	15 Participants	9 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	43 Participants	26 Participants	23 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	36 Participants	23 Participants	20 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	17 Participants	12 Participants	14 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	12 Participants	8 Participants	9 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	12 Participants	10 Participants	7 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	49 Participants	27 Participants	31 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	3 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	42 Participants	18 Participants	31 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	1 Participants	1 Participants	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	36 Participants	12 Participants	19 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 2	14 Participants	17 Participants	16 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	39 Participants	25 Participants	31 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	26 Participants	13 Participants	11 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	24 Participants	9 Participants	11 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	19 Participants	14 Participants	8 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	17 Participants	9 Participants	8 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	6 Participants	5 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	5 Participants	4 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	59 Participants	39 Participants	41 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	3 Participants	1 Participants	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	52 Participants	29 Participants	38 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	53 Participants	30 Participants	31 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	1 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	45 Participants	22 Participants	24 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Across doses	27 Participants	27 Participants	20 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Across doses	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Across doses	22 Participants	21 Participants	20 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	53 Participants	34 Participants	40 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	46 Participants	28 Participants	37 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	34 Participants	22 Participants	20 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	28 Participants	15 Participants	18 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	24 Participants	19 Participants	13 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	18 Participants	13 Participants	10 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	7 Participants	5 Participants	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	5 Participants	4 Participants	2 Participants	0 Participants

SECONDARY outcome

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

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

The number of days with any solicited general symptoms reported during the solicited post-vaccination period.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=49 Doses Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=27 Doses Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=31 Doses 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=18 Doses Healthy male or female adults, \> 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 Month 6 (M6).
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Fatigue, post-Dose 2	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Fatigue, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Headache, post-Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.5	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Headache, post-Dose 2	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	3.0 Days Interval 1.0 to 4.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Joint pain, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0	3.0 Days Interval 1.5 to 4.5
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Joint pain, post-Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Muscle aches, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Muscle aches, post-Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 3.0	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Sweating, post-Dose 1	1.5 Days Interval 1.0 to 2.5	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Sweating, post-Dose 2	2.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Shivering, post-Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.5	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Shivering, post-Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Temperature, post-Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited General Symptoms Occurring in Response to Individual Doses Temperature, post-Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	2.0 Days Interval 2.0 to 2.0	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 42 - Interim analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administrated documented.

An AESI/pIMD 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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Day 203 - Interim analysis posted at Day 182/203

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

An AESI/pIMD 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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Day 364

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

An AESI/pIMD 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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) Any AESI(s)	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) Related AESI(s)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Day 364

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Adverse Events of Specific Interest (AESIs) Any AESI(s)	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Adverse Events of Specific Interest (AESIs) Related AESI(s)	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Day 546

Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A M6 Groups with at least 1 vaccine administration documented.

An AESI/pIMD 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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=70 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=52 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) Any AESI(s)	1 Participants	0 Participants	—	—
Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs) Related AESI(s)	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: At Day 0 and 21 - Interim analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above in subjects aged 18-60 years and > 6 years old.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=163 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=143 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Within	152 Participants	102 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Below	0 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Within	153 Participants	110 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Above	5 Participants	29 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Below	0 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Unknown	0 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Below	4 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Within	144 Participants	129 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Above	13 Participants	12 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Unknown	1 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Below	3 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Within	143 Participants	123 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Above	12 Participants	14 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Unknown	1 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Below	7 Participants	5 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Within	150 Participants	135 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Above	3 Participants	3 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Below	8 Participants	5 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Within	149 Participants	128 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Above	2 Participants	4 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Unknown	0 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Below	2 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Within	149 Participants	130 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Above	10 Participants	10 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Unknown	1 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Within	147 Participants	125 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Above	11 Participants	10 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Unknown	1 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Below	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Within	153 Participants	137 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Above	7 Participants	4 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Unknown	1 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Below	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Within	151 Participants	132 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Above	7 Participants	5 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Below	5 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Within	149 Participants	120 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Above	7 Participants	21 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Below	5 Participants	3 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Within	146 Participants	119 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Above	8 Participants	15 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Unknown	2 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Below	1 Participants	3 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Above	7 Participants	33 Participants	—	—

SECONDARY outcome

Timeframe: At Days 0, 21 and 42 - Interim analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Below	4 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Below	0 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 42 - Within	88 Participants	79 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 42 - Above	4 Participants	6 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Above	5 Participants	12 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Unknown	0 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Within	83 Participants	83 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Above	4 Participants	6 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Unknown	1 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Below	3 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Within	83 Participants	74 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Above	3 Participants	11 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 42 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 42 - Below	3 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 42 - Within	84 Participants	79 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 42 - Above	5 Participants	6 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Unknown	1 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Below	3 Participants	22 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Within	85 Participants	86 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Above	2 Participants	3 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Below	3 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Within	86 Participants	79 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Above	1 Participants	4 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 - Below	2 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 - Within	88 Participants	82 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 - Above	2 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Unknown	0 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Below	1 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Within	87 Participants	81 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Above	3 Participants	7 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Unknown	1 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Within	85 Participants	75 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Above	4 Participants	8 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 42 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 42 - Below	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Unknown	0 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Below	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Within	86 Participants	88 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Above	5 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Unknown	1 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Below	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Within	86 Participants	83 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Above	3 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 - Below	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 - Within	89 Participants	84 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 - Above	3 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Below	1 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Within	86 Participants	75 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Above	4 Participants	15 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Below	2 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Within	83 Participants	73 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 - Below	5 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 - Within	84 Participants	75 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 - Above	3 Participants	8 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Unknown	2 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Below	1 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Within	87 Participants	67 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Above	1 Participants	22 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Unknown	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Below	0 Participants	1 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Within	87 Participants	60 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Above	3 Participants	24 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 - Unknown	3 Participants	2 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 - Below	0 Participants	0 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 - Within	84 Participants	66 Participants	—	—
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 - Above	5 Participants	17 Participants	—	—

SECONDARY outcome

Timeframe: At Days 0, 21, 42 and 182

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Within	83 Participants	83 Participants	60 Participants	46 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Above	2 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Below	3 Participants	2 Participants	5 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 - Unknown	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 42 - Below	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 42 - Above	4 Participants	6 Participants	9 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 182 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 182 - Within	86 Participants	79 Participants	59 Participants	44 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 182 - Above	2 Participants	6 Participants	4 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Within	86 Participants	87 Participants	66 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Above	5 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 - Unknown	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 - Within	89 Participants	84 Participants	63 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 182 - Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Below	1 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Within	86 Participants	75 Participants	63 Participants	45 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 182 - Within	81 Participants	76 Participants	57 Participants	42 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 182 - Above	3 Participants	9 Participants	4 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Unknown	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Within	85 Participants	75 Participants	61 Participants	50 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 182 - Above	2 Participants	9 Participants	10 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Unknown	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Below	3 Participants	2 Participants	4 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 - Within	85 Participants	86 Participants	64 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Within	86 Participants	79 Participants	62 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 - Above	1 Participants	3 Participants	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 - Below	2 Participants	2 Participants	3 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 - Within	88 Participants	82 Participants	63 Participants	47 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 - Above	2 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 182 - Unknown	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 182 - Below	4 Participants	2 Participants	1 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 182 - Within	81 Participants	81 Participants	62 Participants	43 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 182 - Above	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Unknown	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Below	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Within	87 Participants	81 Participants	61 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 0 - Above	3 Participants	7 Participants	7 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Unknown	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 21 - Above	4 Participants	8 Participants	7 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 42 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 42 - Within	88 Participants	79 Participants	58 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 - Within	84 Participants	75 Participants	62 Participants	47 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 - Above	3 Participants	8 Participants	2 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT, Day 182 - Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 - Unknown	0 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 182 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 182 - Below	4 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Below	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Unknown	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Within	86 Participants	82 Participants	64 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Within	87 Participants	67 Participants	65 Participants	43 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 - Above	3 Participants	2 Participants	4 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 - Above	1 Participants	22 Participants	4 Participants	7 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 - Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Below	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Within	87 Participants	60 Participants	64 Participants	42 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 - Above	3 Participants	24 Participants	4 Participants	9 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 - Above	3 Participants	1 Participants	4 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 182 - Unknown	1 Participants	4 Participants	1 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 - Unknown	3 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 182 - Within	84 Participants	80 Participants	59 Participants	41 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 - Below	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 182 - Above	3 Participants	1 Participants	3 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 - Within	84 Participants	66 Participants	60 Participants	43 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 - Above	5 Participants	17 Participants	5 Participants	6 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 - Above	4 Participants	14 Participants	2 Participants	6 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Below	2 Participants	0 Participants	3 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Within	83 Participants	73 Participants	62 Participants	46 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 - Above	5 Participants	11 Participants	3 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 - Below	5 Participants	2 Participants	4 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Unknown	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Below	4 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 0 - Above	4 Participants	5 Participants	9 Participants	6 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Unknown	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Below	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Within	83 Participants	74 Participants	59 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 21 - Above	3 Participants	10 Participants	9 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 42 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 42 - Below	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 42 - Within	84 Participants	79 Participants	61 Participants	47 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 42 - Above	5 Participants	6 Participants	7 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 182 - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 182 - Below	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT, Day 182 - Within	84 Participants	76 Participants	53 Participants	42 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 182 - Unknown	1 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 182 - Below	1 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 182 - Within	81 Participants	59 Participants	54 Participants	36 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 182 - Above	5 Participants	24 Participants	6 Participants	8 Participants

SECONDARY outcome

Timeframe: At Day 364

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=85 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=83 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=62 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=47 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT - Within	79 Participants	77 Participants	57 Participants	45 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT - Above	4 Participants	5 Participants	5 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP - Below	3 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP - Within	82 Participants	82 Participants	62 Participants	45 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT - Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT - Below	1 Participants	0 Participants	5 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT - Above	3 Participants	6 Participants	2 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL - Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL - Above	3 Participants	1 Participants	3 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE - Unknown	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT - Unknown	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALAT - Below	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP - Above	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ASAT - Within	81 Participants	77 Participants	55 Participants	46 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL - Unknown	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL - Within	81 Participants	82 Participants	59 Participants	44 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE - Below	2 Participants	0 Participants	4 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE - Within	82 Participants	75 Participants	56 Participants	41 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE - Above	1 Participants	7 Participants	2 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN - Unknown	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN - Below	0 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN - Within	84 Participants	65 Participants	57 Participants	37 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN - Above	0 Participants	18 Participants	2 Participants	7 Participants

SECONDARY outcome

Timeframe: Within the 42-day (Days 0-41) post vaccination period - Interim analysis posted at Day 42

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

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. Note: GSK2340272A 18-60 years (D21) GROUP and GSK2340272A >60 years (D21) GROUP presents results after the 2 vaccine dose; GSK2340272A 18-60 years (M6) GROUP and GSK2340272A >60 years (M6) GROUP presents result after 1 vaccine dose.

Outcome measures

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	40 Participants	38 Participants	27 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	6 Participants	6 Participants	6 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	11 Participants	15 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Within 21- days post-Dose 1 vaccination (Days 0-20 in both groups) and either 63 days post-Dose 2 vaccination (Days 21-84 in D21 groups) or 21 days post-Dose 2 vaccination (Day 182-203 in M6 groups) - Interim analysis at Day 182/203

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	52 Participants	53 Participants	30 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	10 Participants	9 Participants	6 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	12 Participants	15 Participants	10 Participants	5 Participants

SECONDARY outcome

Timeframe: Within the 21-days post-Dose 1 vaccination (Days 0-20 in both groups) and either 63 days post-Dose 2 vaccination (Days 21-84 in D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 in M6 groups)

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	52 Participants	53 Participants	35 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	10 Participants	9 Participants	6 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	12 Participants	15 Participants	13 Participants	5 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Day 364

Population: The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=93 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=91 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) GROUP n=70 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP n=52 Participants Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Serious Adverse Events (SAEs)	4 Participants	7 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Day 546

Population: The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A M6 Groups with at least 1 vaccine administration documented.

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

Measure	GSK2340272A 18-60 YEARS SUB-GROUP n=70 Participants Pooled group for 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 and at Month 6.	GSK2340272A > 60 YEARS SUB-GROUP n=52 Participants Pooled group for healthy male or female adults, older than 60 years of age (\>60), 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 and at Month 6.	GSK2340272A 18-60 Years (M6) 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 Month 6 (M6).	GSK2340272A > 60 Years (M6) GROUP Healthy male or female adults, \> 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 Month 6 (M6).
Number of Subjects With Serious Adverse Events (SAEs)	4 Participants	4 Participants	—	—

Adverse Events

GSK2340272A (D21) GROUP

Serious events: 11 serious events

Other events: 174 other events

Deaths: 0 deaths

GSK2340272A (M6) GROUP

Serious events: 8 serious events

Other events: 117 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK2340272A (D21) GROUP n=184 participants at risk Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 (D21).	GSK2340272A (M6) GROUP n=122 participants at risk Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 Month 6 (M6).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Psychiatric disorders Suicide attempt	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Renal and urinary disorders Nephrolithiasis	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Reproductive system and breast disorders Ovarian cyst	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Cardiac disorders Acute coronary syndrome	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Cardiac disorders Coronary artery disease	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Ear and labyrinth disorders Vertigo	1.1% 2/184 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
General disorders Chest pain	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Infections and infestations Herpes zoster	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Infections and infestations Pneumonia	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Infections and infestations Post procedural infection	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Infections and infestations Pyelonephritis	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Investigations Hepatic enzyme increased	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.82% 1/122 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to ovary	0.54% 1/184 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	0.00% 0/122 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).

Other adverse events

Measure	GSK2340272A (D21) GROUP n=184 participants at risk Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 (D21).	GSK2340272A (M6) GROUP n=122 participants at risk Healthy male or female adults, divided into subjects between and including 18 to 60 years of age and subjects older than 60 years of age (\>60), 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 Month 6 (M6).
Musculoskeletal and connective tissue disorders Arthralgia	29.9% 55/184 • Number of events 82 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	32.0% 39/122 • Number of events 51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Musculoskeletal and connective tissue disorders Back pain	4.9% 9/184 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	6.6% 8/122 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
General disorders Chills	30.4% 56/184 • Number of events 68 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	26.2% 32/122 • Number of events 40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Skin and subcutaneous tissue disorders Erythema	16.8% 31/184 • Number of events 35 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	13.9% 17/122 • Number of events 18 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
General disorders Fatigue	53.8% 99/184 • Number of events 144 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	55.7% 68/122 • Number of events 92 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Nervous system disorders Headache	47.8% 88/184 • Number of events 129 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	39.3% 48/122 • Number of events 77 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Skin and subcutaneous tissue disorders Hyperhidrosis	23.4% 43/184 • Number of events 55 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	19.7% 24/122 • Number of events 26 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Musculoskeletal and connective tissue disorders Myalgia	47.8% 88/184 • Number of events 134 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	53.3% 65/122 • Number of events 85 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Infections and infestations Nasopharyngitis	10.9% 20/184 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	9.0% 11/122 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.2% 4/184 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	5.7% 7/122 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
General disorders Pain	91.8% 169/184 • Number of events 301 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	88.5% 108/122 • Number of events 183 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
General disorders Pyrexia	7.6% 14/184 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	5.7% 7/122 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
Infections and infestations Rhinitis	10.9% 20/184 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	7.4% 9/122 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).
General disorders Swelling	16.3% 30/184 • Number of events 35 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).	13.9% 17/122 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21 days post-Dose 1 vaccination (Days 0-20 for all groups) and either 63 days post-Dose 2 vaccination (Days 21-84 for D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 for M6 groups); SAEs: during the entire study period (from Day 0 up to Day 364 for the D21 groups and up to Day 546 for M6 groups).

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