Trial Outcomes & Findings for Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults (NCT NCT00968526)

Last Updated: 2019-06-25

Results Overview

Seroconversion was defined as: For initially seronegative subjects \[antibody titer (below) \< 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 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). This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. 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 .

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

240 participants

Primary outcome timeframe

At Day 21

Results posted on

2019-06-25

Participant Flow

At Day 21, all subjects had received 1 dose of GSK2340272A vaccine and therefore no distinction was made between groups for the Day 21 analysis.

Participant milestones

Participant milestones
Measure	GSK2340272A 2D Group Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D Group Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Overall Study STARTED	138	102
Overall Study COMPLETED	135	102
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2340272A 2D Group Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D Group Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Overall Study Adverse Event	2	0
Overall Study Migrated/moved from study area	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2340272A 2D Group n=138 Participants Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D Group n=102 Participants Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	Total n=240 Participants Total of all reporting groups
Age, Continuous	55.0 Years STANDARD_DEVIATION 18.2 • n=5 Participants	53.6 Years STANDARD_DEVIATION 18.3 • n=7 Participants	54.4 Years STANDARD_DEVIATION 18.2 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	49 Participants n=7 Participants	117 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	53 Participants n=7 Participants	123 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	138 Participants n=5 Participants	102 Participants n=7 Participants	240 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second dose.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=66 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies	63 Participants	53 Participants	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second 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. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum. 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

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=66 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain	65 Participants	59 Participants	—	—

PRIMARY outcome

Timeframe: At Day 21

GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was \> 2.5 in subjects 18 to 60 years old or \> 2 for subjects \> 60 years of age.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=66 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	38.71 Fold change Interval 29.1 to 51.51	13.86 Fold change Interval 10.29 to 18.65	—	—

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose and 2 doses were administered and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.

A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=66 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=49 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 0	24 Participants	28 Participants	20 Participants	21 Participants
Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 21	66 Participants	67 Participants	50 Participants	47 Participants
Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 42	66 Participants	67 Participants	50 Participants	48 Participants

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose and 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.

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. The results for this assay were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=66 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=49 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 0	8.8 Titers Interval 7.0 to 10.9	10.3 Titers Interval 7.7 to 13.7	8.6 Titers Interval 6.8 to 10.8	9.7 Titers Interval 7.3 to 13.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 21	339.1 Titers Interval 258.6 to 444.8	142.7 Titers Interval 108.5 to 187.8	388.6 Titers Interval 262.0 to 576.2	129.3 Titers Interval 89.9 to 186.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 42	610.6 Titers Interval 507.9 to 734.0	345.8 Titers Interval 278.0 to 430.1	331.2 Titers Interval 220.7 to 497.1	117.1 Titers Interval 82.4 to 166.4

SECONDARY outcome

Timeframe: At Day 182 and 364

Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 182	67 Participants	68 Participants	51 Participants	46 Participants
Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 364	67 Participants	65 Participants	44 Participants	41 Participants

SECONDARY outcome

Timeframe: At Day 182 and 364

Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and whom assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 364	90.5 Titers Interval 69.4 to 118.1	42.3 Titers Interval 32.6 to 54.8	64.2 Titers Interval 41.3 to 99.7	28.1 Titers Interval 19.4 to 40.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 182	214.8 Titers Interval 169.8 to 271.8	108.7 Titers Interval 85.7 to 137.8	143.5 Titers Interval 96.6 to 213.0	51.6 Titers Interval 34.9 to 76.5

SECONDARY outcome

Timeframe: At Days 21 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose was administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days and 42 days after the first vaccine dose.

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post to vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 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). This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. 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

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=49 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease Flu A/CAL/7/2009, Day 21	47 Participants	38 Participants	—	—
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease Flu A/CAL/7/2009, Day 42	46 Participants	39 Participants	—	—

SECONDARY outcome

Timeframe: At Days 182 and 364

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post to vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 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 results for this assay were tabulated per age stratum. 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

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 182	63 Participants	52 Participants	42 Participants	21 Participants
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 364	50 Participants	28 Participants	32 Participants	15 Participants

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

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. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. 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

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=49 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
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	4 Participants	5 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	48 Participants	42 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	47 Participants	43 Participants	—	—

SECONDARY outcome

Timeframe: At Days 182 and 364

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 results for this assay were tabulated per age stratum. 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

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
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 182	65 Participants	61 Participants	44 Participants	28 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 364	53 Participants	37 Participants	34 Participants	22 Participants

SECONDARY outcome

Timeframe: At Days 21 and 42

GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was \> 2.5 in subjects 18 to 60 years old or \> 2 for subjects \> 60 years of age.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=49 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
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	45.30 Fold change Interval 30.32 to 67.68	13.32 Fold change Interval 9.04 to 19.61	—	—
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	38.62 Fold change Interval 25.96 to 57.45	12.06 Fold change Interval 8.39 to 17.33	—	—

SECONDARY outcome

Timeframe: At Day 182 and 364

GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was \> 2.5 in subjects 18 to 60 years old or \> 2 for subjects \> 60 years of age.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=67 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 182	24.73 Fold change Interval 19.31 to 31.67	10.45 Fold change Interval 8.24 to 13.24	17.14 Fold change Interval 11.83 to 24.84	5.31 Fold change Interval 3.73 to 7.56
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 364	10.4 Fold change Interval 8.1 to 13.4	4.3 Fold change Interval 3.5 to 5.2	7.6 Fold change Interval 5.1 to 11.5	2.9 Fold change Interval 2.1 to 4.0

SECONDARY outcome

Timeframe: At Days 0, 21, 42 and 182

Population: The analysis was performed on the ATP cohort for persistence at Day 182, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 were available.

A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:8, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/Neth/602/09. The results for this assay were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=22 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=22 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=17 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=18 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 Flu A/Neth/602/09, Day 0	16 Participants	17 Participants	11 Participants	12 Participants
Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 Flu A/Neth/602/09, Day 21	21 Participants	22 Participants	17 Participants	18 Participants
Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 Flu A/Neth/602/09, Day 42	22 Participants	22 Participants	17 Participants	18 Participants
Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 Flu A/Neth/602/09, Day 182	21 Participants	22 Participants	16 Participants	16 Participants

SECONDARY outcome

Timeframe: At Days 0, 21, 42 and 182

Population: The analysis was performed on the ATP cohort for persistence at Day 182, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against the study vaccine antigen component at Day 182 were available.

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. The results for this assay were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=22 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=22 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=17 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=18 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09, Day 0	11.9 Titers Interval 8.0 to 17.8	16.9 Titers Interval 10.1 to 28.1	12.6 Titers Interval 6.7 to 23.9	21.3 Titers Interval 10.1 to 44.9
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09, Day 21	199.8 Titers Interval 94.1 to 424.2	169.7 Titers Interval 85.6 to 336.5	199.1 Titers Interval 92.3 to 429.7	83.5 Titers Interval 38.8 to 179.4
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09, Day 42	326.8 Titers Interval 183.0 to 583.3	309.5 Titers Interval 189.3 to 505.9	136.7 Titers Interval 64.8 to 288.6	86.7 Titers Interval 48.0 to 156.7
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09, Day 182	128.7 Titers Interval 73.5 to 225.2	96.7 Titers Interval 59.3 to 157.5	55.2 Titers Interval 24.7 to 123.3	65.3 Titers Interval 30.8 to 138.4

SECONDARY outcome

Timeframe: At Days 21, 42 and 182

Population: The analysis was performed on the ATP cohort for persistence at Day 182, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against the study vaccine antigen component at Day 182 were available.

Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:8 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09. The results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=22 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=22 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=17 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=18 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Flu A/Neth/602/09, Day 21	15 Participants	15 Participants	12 Participants	6 Participants
Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Flu A/Neth/602/09, Day 42	20 Participants	19 Participants	11 Participants	5 Participants
Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Flu A/Neth/602/09, Day 182	18 Participants	14 Participants	6 Participants	7 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-dose 1 vaccination period

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects who filled in their symptom sheets. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=120 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=120 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	105 Participants	78 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	1 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	11 Participants	12 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-dose 1 vaccination period

The number of days with any solicited local symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=105 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=82 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Days With Solicited Local Symptoms Pain	3.0 Days Interval 2.0 to 4.0	2.5 Days Interval 1.0 to 4.0	—	—
Number of Days With Solicited Local Symptoms Redness	1.0 Days Interval 1.0 to 1.0	2.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited Local Symptoms Swelling	2.0 Days Interval 2.0 to 2.0	2.0 Days Interval 1.0 to 2.0	—	—

SECONDARY outcome

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

Population: The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A vaccine and who filled in their symptom sheets.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=70 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	57 Participants	46 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	0 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	0 Participants	3 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	5 Participants	4 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	51 Participants	42 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	1 Participants	5 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	3 Participants	3 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	1 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	61 Participants	52 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	2 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	1 Participants	6 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	7 Participants	6 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	0 Participants	1 Participants	—	—

SECONDARY outcome

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

Population: The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A and who filled in their symptom sheets.

The number of days with any solicited local symptoms reported during the solicited post-vaccination period. This outcome included only subjects who received 2 doses of the study product and the results were tabulated per age stratum. No subjects from GSK2340272A 2D (18-60y) Sub-Group presented any redness post dose 1.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=70 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Days With Solicited Local Symptoms Pain, Overall/dose	3.0 Days Interval 2.0 to 3.5	2.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited Local Symptoms Pain, Dose 1	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited Local Symptoms Pain, Dose 2	3.0 Days Interval 2.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited Local Symptoms Redness, Dose 1	0 Days Interval 0.0 to 0.0	1.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited Local Symptoms Redness, Dose 2	1.0 Days Interval 1.0 to 1.0	2.0 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited Local Symptoms Redness, Overall/dose	1.0 Days Interval 1.0 to 1.0	1.5 Days Interval 1.0 to 2.5	—	—
Number of Days With Solicited Local Symptoms Swelling, Dose 1	2.0 Days Interval 2.0 to 2.0	2.0 Days Interval 1.5 to 2.5	—	—
Number of Days With Solicited Local Symptoms Swelling, Dose 2	2.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 1.0	—	—
Number of Days With Solicited Local Symptoms Swelling, Overall/dose	2.0 Days Interval 1.5 to 2.5	1.0 Days Interval 1.0 to 2.0	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-dose 1 vaccination period

Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above (\>) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=120 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=120 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	43 Participants	26 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	2 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	40 Participants	24 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	44 Participants	22 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	43 Participants	21 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain	19 Participants	17 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain	0 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain	17 Participants	14 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches	29 Participants	25 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches	2 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches	25 Participants	23 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering	23 Participants	7 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering	22 Participants	7 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating	19 Participants	6 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	17 Participants	6 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature	1 Participants	0 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-dose 1 vaccination period

The number of days with any solicited general symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=78 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Days With Solicited General Symptoms Fatigue	2.0 Days Interval 1.0 to 4.0	1.5 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Headache	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited General Symptoms Joint pain	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 4.0	—	—
Number of Days With Solicited General Symptoms Muscle aches	2.0 Days Interval 2.0 to 4.0	3.0 Days Interval 1.0 to 4.0	—	—
Number of Days With Solicited General Symptoms Shivering	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited General Symptoms Sweating	2.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Temperature	1.0 Days Interval 1.0 to 3.0	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

Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature above (\>) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. This outcome inlcuded only subjects who received two doses of the study product and the results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=70 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	3 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	24 Participants	15 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	2 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	21 Participants	14 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	23 Participants	12 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	22 Participants	11 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 1	12 Participants	9 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	10 Participants	6 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	19 Participants	12 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	15 Participants	10 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	14 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	13 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	12 Participants	5 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	11 Participants	5 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	1 Participants	0 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	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	19 Participants	15 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	2 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	19 Participants	15 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	15 Participants	12 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	15 Participants	12 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 2	11 Participants	13 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 2	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 2	11 Participants	13 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	15 Participants	13 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	15 Participants	13 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	18 Participants	5 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	2 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	18 Participants	5 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	11 Participants	5 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	11 Participants	5 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	2 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	2 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	29 Participants	26 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	3 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	27 Participants	25 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	29 Participants	20 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	2 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	28 Participants	19 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Across doses	16 Participants	18 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Across doses	1 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Across doses	15 Participants	16 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	26 Participants	22 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	2 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	23 Participants	20 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	22 Participants	7 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	2 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	21 Participants	7 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	19 Participants	9 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	18 Participants	9 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	3 Participants	0 Participants	—	—

SECONDARY outcome

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

The number of days with any solicited general symptoms reported during the solicited post-vaccination period. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum. No subjects from GSK2340272A 2D (\>60y) Sub-Group reported any temperature.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=70 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Days With Solicited General Symptoms Fatigue, Dose 1	2.0 Days Interval 1.5 to 4.5	1.0 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Fatigue, Dose 2	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Fatigue, Overall/dose	2.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Headache, Dose 1	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.5	—	—
Number of Days With Solicited General Symptoms Headache, Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Headache, Overall/dose	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Joint pain, Dose 1	2.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 5.0	—	—
Number of Days With Solicited General Symptoms Joint pain, Dose 2	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Joint pain, Overall/dose	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited General Symptoms Muscle aches, Dose 1	2.0 Days Interval 2.0 to 4.0	2.5 Days Interval 1.0 to 4.5	—	—
Number of Days With Solicited General Symptoms Muscle aches, Dose 2	2.0 Days Interval 2.0 to 3.0	1.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited General Symptoms Muscle aches, Overall/dose	2.0 Days Interval 2.0 to 4.0	1.0 Days Interval 1.0 to 4.0	—	—
Number of Days With Solicited General Symptoms Sweating, Dose 1	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Sweating, Dose 2	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 1.0	—	—
Number of Days With Solicited General Symptoms Sweating, Overall/dose	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited General Symptoms Shivering, Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	—	—
Number of Days With Solicited General Symptoms Shivering, Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	—	—
Number of Days With Solicited General Symptoms Shivering, Overall/dose	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	—	—
Number of Days With Solicited General Symptoms Temperature, Dose 1	1.0 Days Interval 1.0 to 1.0	NA Days No subjects from GSK2340272A (\>60y) Sub-Group reported any temperature for dose 1.	—	—
Number of Days With Solicited General Symptoms Temperature, Dose 2	2.0 Days Interval 2.0 to 2.0	NA Days No subjects from GSK2340272A (\>60y) Sub-Group reported any temperature for dose 2.	—	—
Number of Days With Solicited General Symptoms Temperature, Overall/dose	2.0 Days Interval 1.0 to 2.0	NA Days No subjects from GSK2340272A (\>60y) Sub-Group reported any temperature across doses.	—	—

SECONDARY outcome

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

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

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. The results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=70 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects With Adverse Events of Specific Interest (AESIs)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 0, 21, 42, 182 and 364

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

Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[AST\], total 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 \> 60 years old.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=70 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 0 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 0 · Within	56 Participants	66 Participants	44 Participants	48 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 0 · Above	12 Participants	4 Participants	8 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 21 · Within	56 Participants	65 Participants	45 Participants	46 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 21 · Above	12 Participants	5 Participants	7 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 42 · Within	57 Participants	68 Participants	46 Participants	44 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 42 · Above	11 Participants	2 Participants	6 Participants	6 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 182 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 182 · Within	57 Participants	63 Participants	47 Participants	48 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 182 · Above	10 Participants	6 Participants	5 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 364 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 364 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 364 · Within	58 Participants	65 Participants	47 Participants	47 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels ALT, Day 364 · Above	9 Participants	3 Participants	5 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 · Within	67 Participants	70 Participants	51 Participants	45 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 0 · Above	1 Participants	0 Participants	1 Participants	5 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	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 · Within	67 Participants	69 Participants	52 Participants	46 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 21 · Above	1 Participants	1 Participants	0 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 · Within	66 Participants	68 Participants	52 Participants	44 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 42 · Above	2 Participants	2 Participants	0 Participants	6 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 182 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 182 · Within	65 Participants	66 Participants	51 Participants	45 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 182 · Above	2 Participants	3 Participants	1 Participants	5 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 364 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 364 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 364 · Within	63 Participants	67 Participants	51 Participants	47 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AP, Day 364 · Above	4 Participants	1 Participants	1 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 0 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 0 · Within	63 Participants	66 Participants	47 Participants	48 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 0 · Above	5 Participants	4 Participants	5 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 21 · Within	67 Participants	67 Participants	49 Participants	48 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 21 · Above	1 Participants	3 Participants	3 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 42 · Within	63 Participants	66 Participants	45 Participants	48 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 42 · Above	5 Participants	4 Participants	7 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 182 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 182 · Within	62 Participants	64 Participants	47 Participants	48 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 182 · Above	5 Participants	5 Participants	5 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 364 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 364 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 364 · Within	63 Participants	65 Participants	49 Participants	48 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels AST, Day 364 · Above	4 Participants	3 Participants	3 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 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	64 Participants	68 Participants	49 Participants	48 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 0 · Above	4 Participants	2 Participants	3 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 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 21 · Within	64 Participants	66 Participants	49 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 21 · Above	4 Participants	4 Participants	3 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 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 BIL, Day 42 · Within	64 Participants	67 Participants	50 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 42 · Above	4 Participants	3 Participants	2 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 182 · Unknown	0 Participants	0 Participants	0 Participants	0 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 BIL, Day 182 · Within	65 Participants	68 Participants	51 Participants	50 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 182 · Above	2 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 364 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 364 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 364 · Within	59 Participants	64 Participants	46 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BIL, Day 364 · Above	8 Participants	4 Participants	6 Participants	1 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 CRE, Day 0 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 · Within	59 Participants	52 Participants	50 Participants	42 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 0 · Above	9 Participants	18 Participants	2 Participants	8 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	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 · Within	60 Participants	51 Participants	49 Participants	41 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 21 · Above	8 Participants	19 Participants	3 Participants	9 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	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 · Within	60 Participants	54 Participants	51 Participants	41 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 42 · Above	8 Participants	16 Participants	1 Participants	9 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	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 182 · Within	57 Participants	51 Participants	50 Participants	41 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 182 · Above	10 Participants	18 Participants	2 Participants	9 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 364 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 364 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 364 · Within	63 Participants	60 Participants	52 Participants	45 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels CRE, Day 364 · Above	4 Participants	8 Participants	0 Participants	5 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 · Within	66 Participants	58 Participants	51 Participants	47 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 0 · Above	2 Participants	12 Participants	1 Participants	3 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	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 · Within	66 Participants	59 Participants	51 Participants	42 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 21 · Above	2 Participants	11 Participants	1 Participants	8 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 · Within	64 Participants	57 Participants	51 Participants	43 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 42 · Above	4 Participants	13 Participants	1 Participants	7 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 182 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 182 · Within	67 Participants	59 Participants	50 Participants	43 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 182 · Above	0 Participants	10 Participants	2 Participants	7 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 364 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 364 · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 364 · Within	67 Participants	60 Participants	52 Participants	45 Participants
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels BUN, Day 364 · Above	0 Participants	8 Participants	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Within 21 days after the first vaccination (Day 0 - Day 20)

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.

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. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=120 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=120 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	53 Participants	31 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	10 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	24 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: Within 84 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 83)

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

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=70 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	45 Participants	46 Participants	39 Participants	30 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	13 Participants	9 Participants	10 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	15 Participants	10 Participants	9 Participants	7 Participants

SECONDARY outcome

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

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

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The results were tabulated per age stratum.

Outcome measures

Outcome measures
Measure	GSK2340272A 2D (18-60y) Sub-Group n=68 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 2D (>60y) Sub-Group n=70 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340272A 1D (18-60y) Sub-Group n=52 Participants Sub-Group of healthy male or female adults, aged 18 to 60 years (18-60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 1D (>60y) Sub-Group n=50 Participants Sub-Group of healthy male or female adults, above 60 years (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	10 Participants	3 Participants	3 Participants

Adverse Events

GSK2340272A 1D Group

Serious events: 6 serious events

Other events: 89 other events

Deaths: 0 deaths

GSK2340272A 2D Group

Serious events: 10 serious events

Other events: 126 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK2340272A 1D Group n=102 participants at risk Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 2D Group n=138 participants at risk Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Musculoskeletal and connective tissue disorders Arthralgia	15.7% 16/102 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	25.4% 35/138 • Number of events 46 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
General disorders Chills	13.7% 14/102 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	21.0% 29/138 • Number of events 39 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Skin and subcutaneous tissue disorders Erythema	7.8% 8/102 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	6.5% 9/138 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
General disorders Fatigue	29.4% 30/102 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	41.3% 57/138 • Number of events 77 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Nervous system disorders Headache	34.3% 35/102 • Number of events 38 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	38.4% 53/138 • Number of events 75 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Skin and subcutaneous tissue disorders Hyperhidrosis	7.8% 8/102 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	20.3% 28/138 • Number of events 33 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Musculoskeletal and connective tissue disorders Myalgia	22.5% 23/102 • Number of events 23 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	34.8% 48/138 • Number of events 59 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Infections and infestations Nasopharyngitis	19.6% 20/102 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	24.6% 34/138 • Number of events 39 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
General disorders Pain	78.4% 80/102 • Number of events 81 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	81.9% 113/138 • Number of events 196 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
General disorders Swelling	13.7% 14/102 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	10.1% 14/138 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Infections and infestations Upper respiratory tract infection	6.9% 7/102 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	3.6% 5/138 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER

Measure	GSK2340272A 1D Group n=102 participants at risk Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A 2D Group n=138 participants at risk Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Vascular disorders Aortic stenosis	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Cardiac disorders Arrhytmia	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Vascular disorders Arterial thrombosis limb	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Cardiac disorders Atrial fibrillation	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Nervous system disorders Cerebrovascular accident	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Nervous system disorders Cervical root pain	0.98% 1/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.00% 0/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Hepatobiliary disorders Cholelithiasis	0.98% 1/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.00% 0/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Injury, poisoning and procedural complications Concussion	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Injury, poisoning and procedural complications Contusion	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Infections and infestations Cystitis	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Vascular disorders Deep vein thrombosis	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Immune system disorders Drug hypersensitivity	0.98% 1/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.00% 0/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Injury, poisoning and procedural complications Hand fracture	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Nervous system disorders Headache	0.98% 1/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.00% 0/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.98% 1/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.00% 0/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Splenic marginal zone lymphoma	0.98% 1/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.00% 0/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Nervous system disorders Syncope	0.98% 1/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.00% 0/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Injury, poisoning and procedural complications Tibia fracture	0.98% 1/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.00% 0/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Nervous system disorders Transient ischaemic attack	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Renal and urinary disorders Urethral stenosis	0.00% 0/102 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	0.72% 1/138 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).