Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults (NCT NCT00951041)

Last Updated: 2018-11-26

Results Overview

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

At Day 35

Results posted on

2018-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	GSK2340272A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Overall Study STARTED	64	66
Overall Study COMPLETED	59	65
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2340272A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	1	0
Overall Study Other	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2340272A Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	Total n=130 Participants Total of all reporting groups
Age, Continuous	39.90 Years STANDARD_DEVIATION 11.72 • n=5 Participants	39.30 Years STANDARD_DEVIATION 13.16 • n=7 Participants	39.60 Years STANDARD_DEVIATION 12.43 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	64 Participants n=5 Participants	66 Participants n=7 Participants	130 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 35

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=56 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease	780.2 Titers Interval 650.3 to 936.0	533.6 Titers Interval 412.2 to 690.7

PRIMARY outcome

Timeframe: At Day 35

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.

Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=56 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Seroconverted Subjects for HI Antibodies	56 Participants	60 Participants

PRIMARY outcome

Timeframe: At Day 35

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=56 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Seroprotected Subjects for HI Antibodies	56 Participants	61 Participants

PRIMARY outcome

Timeframe: At Day 35

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=56 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease	73.9 Fold change Interval 55.1 to 99.2	45.6 Fold change Interval 33.3 to 62.2

SECONDARY outcome

Timeframe: At Days 0 and 21

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=56 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease Flu A/California/7/2009, Day 0	10.6 Titers Interval 8.2 to 13.6	11.7 Titers Interval 8.7 to 15.8
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease Flu A/California/7/2009, Day 21	541.7 Titers Interval 415.7 to 706.0	530.5 Titers Interval 391.6 to 718.6

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=62 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease	161.9 Titers Interval 125.8 to 208.4	149.7 Titers Interval 109.9 to 203.8

SECONDARY outcome

Timeframe: At Day 364

Population: The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=58 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease	90.1 Titers Interval 68.9 to 117.8	96.0 Titers Interval 68.7 to 134.2

SECONDARY outcome

Timeframe: At Day 21

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=56 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Seroconverted Subjects for HI Antibodies	55 Participants	58 Participants

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=62 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Seroconverted Subjects for HI Antibodies	53 Participants	49 Participants

SECONDARY outcome

Timeframe: At Day 364

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=58 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Seroconverted Subjects for HI Antibodies	38 Participants	41 Participants

SECONDARY outcome

Timeframe: At Days 0 and 21

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=56 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Seroprotected Subjects for HI Antibodies Flu A/California/7/2009, Day 0	7 Participants	8 Participants
Number of Seroprotected Subjects for HI Antibodies Flu A/California/7/2009, Day 21	55 Participants	60 Participants

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=62 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Seroprotected Subjects for HI Antibodies	56 Participants	56 Participants

SECONDARY outcome

Timeframe: At Day 364

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=58 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Seroprotected Subjects for HI Antibodies	48 Participants	51 Participants

SECONDARY outcome

Timeframe: At Day 21

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=56 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease	51.3 Fold change Interval 36.2 to 72.9	45.3 Fold change Interval 32.6 to 63.0

SECONDARY outcome

Timeframe: At Day 35

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=61 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease	45.6 Fold change Interval 33.3 to 62.2	—

SECONDARY outcome

Timeframe: At Day 182

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=62 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease	15.3 Fold change Interval 11.5 to 20.3	11.7 Fold change Interval 8.7 to 15.9

SECONDARY outcome

Timeframe: At Day 364

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=58 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease	8.4 Fold change Interval 6.2 to 11.3	7.6 Fold change Interval 5.6 to 10.4

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) follow-up period after each dose and across doses

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

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

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	56 Participants	39 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	20 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	20 Participants	1 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	53 Participants	33 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	16 Participants	2 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	12 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	57 Participants	41 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	1 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	24 Participants	3 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	21 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) follow-up period after each dose and overall

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

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

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Days With Solicited Local Symptoms Pain, Post-Dose 1	3.0 Days Interval 3.0 to 5.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited Local Symptoms Pain, Post-Dose 2	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited Local Symptoms Pain, Overall/dose	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited Local Symptoms Redness, Post-Dose 1	2.0 Days Interval 1.0 to 3.5	4.0 Days Interval 1.0 to 4.0
Number of Days With Solicited Local Symptoms Redness, Post-Dose 2	2.0 Days Interval 1.5 to 3.5	1.5 Days Interval 1.0 to 2.0
Number of Days With Solicited Local Symptoms Redness, Overall/dose	2.0 Days Interval 1.0 to 3.5	2.0 Days Interval 1.0 to 4.0
Number of Days With Solicited Local Symptoms Swelling, Post-Dose 1	3.0 Days Interval 2.0 to 4.0	4.0 Days Interval 4.0 to 4.0
Number of Days With Solicited Local Symptoms Swelling, Post-Dose 2	3.0 Days Interval 2.0 to 3.5	1.0 Days Interval 1.0 to 1.0
Number of Days With Solicited Local Symptoms Swelling, Overall/dose	3.0 Days Interval 2.0 to 4.0	2.5 Days Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) follow-up period after each dose and across doses

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

Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 fever = fever above (\>) 40.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	26 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	10 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	19 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	9 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint Pain, Dose 1	15 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint Pain, Dose 1	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint Pain, Dose 1	9 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle Aches, Dose 1	22 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	10 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	7 Participants	7 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	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	9 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 1	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	4 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	29 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	16 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	19 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	11 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint Pain, Dose 2	23 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint Pain, Dose 2	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint Pain, Dose 2	15 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle Aches, Dose 2	30 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle Aches, Dose 2	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle Aches, Dose 2	17 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	12 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	10 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	12 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	8 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	35 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	5 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	20 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	30 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	4 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	17 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint Pain, Across doses	27 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint Pain, Across doses	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint Pain, Across doses	18 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle Aches, Across doses	35 Participants	14 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	18 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	16 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	10 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	17 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	11 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	2 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) follow-up period after each dose and overall

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

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

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Days With Solicited General Symptoms Shivering, post-Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Fatigue, post-Dose 1	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Fatigue, post-Dose 2	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Fatigue, Overall/dose	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Headache, post-Dose 1	2.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Headache, post-Dose 2	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Headache, Overall/dose	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Joint pain, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 3.0
Number of Days With Solicited General Symptoms Joint pain, post-Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Joint pain, Overall/dose	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.5 to 3.0
Number of Days With Solicited General Symptoms Muscle aches, post-Dose 1	2.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Muscle aches, post-Dose 2	2.0 Days Interval 2.0 to 3.0	3.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Muscle aches, Overall/dose	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Sweating, post-Dose 1	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Sweating, post-Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Sweating, Overall/dose	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Shivering, post-Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.5 to 2.0
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 2.0
Number of Days With Solicited General Symptoms Fever, post-Dose 1	NA Days This symptom was not reported for the first dose of study vaccine.	NA Days This symptom was not reported for GSK2340269A Group.
Number of Days With Solicited General Symptoms Fever, post-Dose 2	1.0 Days Interval 1.0 to 1.0	NA Days This symptom was not reported for GSK2340269A Group.
Number of Days With Solicited General Symptoms Fever, Overall/dose	1.0 Days Interval 1.0 to 1.0	NA Days This symptom was not reported for GSK2340269A Group.

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up after the first vaccination and during the 63-day (Days 21-83) follow-up after the second vaccination (From Day 0 to Day 84)

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

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	22 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	1 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	5 Participants	6 Participants

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	GSK2340272A Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=66 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	3 Participants

SECONDARY outcome

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

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

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Outcome measures

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

Adverse Events

GSK2340272A Group

Serious events: 0 serious events

Other events: 61 other events

Deaths: 0 deaths

GSK2340269A Group

Serious events: 3 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK2340272A Group n=64 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=66 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Immune system disorders Hypersensitivity	0.00% 0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	1.5% 1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	1.5% 1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
Injury, poisoning and procedural complications Wound	0.00% 0/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	1.5% 1/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.

Other adverse events

Other adverse events
Measure	GSK2340272A Group n=64 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.	GSK2340269A Group n=66 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.
Infections and infestations Nasopharyngitis	7.8% 5/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	6.1% 4/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Influenza like illness	1.6% 1/64 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	9.1% 6/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Pain	90.5% 57/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	62.1% 41/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Redness	38.1% 24/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	4.5% 3/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Swelling	33.3% 21/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	3.0% 2/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Fatigue	55.6% 35/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	34.8% 23/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Headache	47.6% 30/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	27.3% 18/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Joint pain	42.9% 27/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	15.2% 10/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Muscle aches	55.6% 35/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	21.2% 14/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Shivering	25.4% 16/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	15.2% 10/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.
General disorders Sweating	27.0% 17/63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.	21.2% 14/66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: from Day 0 to Day 84. SAEs: during the entire study period (from Day 0 up to Day 364). Solicited local and general symptoms were collected only from subjects with their symptom sheet completed.

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