Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes (NCT NCT00992511)

Last Updated: 2019-01-31

Results Overview

A seroprotected 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

300 participants

Primary outcome timeframe

At Day 21

Results posted on

2019-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	GSK2340272A New 1D Group Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Overall Study STARTED	76	73	76	75
Overall Study COMPLETED	74	73	74	70
Overall Study NOT COMPLETED	2	0	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2340272A New 1D Group Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 1D Group Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Overall Study Migrated/moved from study area	1	1	2
Overall Study Lost to Follow-up	1	0	2
Overall Study Withdrawal by Subject	0	1	1

Baseline Characteristics

Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2340272A New 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=73 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=75 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Total n=300 Participants Total of all reporting groups
Age, Continuous	39.4 Years STANDARD_DEVIATION 13.02 • n=93 Participants	40.9 Years STANDARD_DEVIATION 12.20 • n=4 Participants	40.5 Years STANDARD_DEVIATION 12.45 • n=27 Participants	38.6 Years STANDARD_DEVIATION 12.10 • n=483 Participants	39.84 Years STANDARD_DEVIATION 12.42 • n=36 Participants
Sex: Female, Male Female	42 Participants n=93 Participants	39 Participants n=4 Participants	43 Participants n=27 Participants	38 Participants n=483 Participants	162 Participants n=36 Participants
Sex: Female, Male Male	34 Participants n=93 Participants	34 Participants n=4 Participants	33 Participants n=27 Participants	37 Participants n=483 Participants	138 Participants n=36 Participants
Race/Ethnicity, Customized White - Arabic/North African heritage	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized White - Caucasian/European heritage	76 Participants n=93 Participants	73 Participants n=4 Participants	76 Participants n=27 Participants	74 Participants n=483 Participants	299 Participants n=36 Participants

PRIMARY outcome

Timeframe: At Day 21

Population: The According-to Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom one or two doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.

A seroprotected 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.

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=69 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain	74 Participants	64 Participants	69 Participants	63 Participants

PRIMARY outcome

Timeframe: At Day 21

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=69 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	323.0 Titers Interval 253.4 to 411.8	334.2 Titers Interval 267.9 to 416.9	341.5 Titers Interval 261.7 to 445.6	398.9 Titers Interval 294.8 to 539.7

SECONDARY outcome

Timeframe: At Days 0 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.

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=71 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/CAL/7/09, Day 0	28 Participants	23 Participants	30 Participants	22 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/CAL/7/09, Day 42	74 Participants	64 Participants	71 Participants	62 Participants

SECONDARY outcome

Timeframe: At Days 0 and 42

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=71 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 0	8.6 Titer Interval 7.0 to 10.6	8.0 Titer Interval 6.7 to 9.6	8.9 Titer Interval 7.2 to 11.0	8.4 Titer Interval 6.8 to 10.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 42	226.4 Titer Interval 176.8 to 289.8	470.0 Titer Interval 387.9 to 569.6	268.4 Titer Interval 206.2 to 349.3	676.8 Titer Interval 564.7 to 811.3

SECONDARY outcome

Timeframe: At Days 182 and 364

Population: The ATP cohort for antibody persistence at Day 182 and 364 included all evaluable subjects for whom one or two doses were taken and for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Day 182 and 364

A seroprotected 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.

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=72 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=68 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=69 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 182	71 Participants	68 Participants	68 Participants	65 Participants
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/California/7/2009, Day 364	64 Participants	63 Participants	60 Participants	58 Participants

SECONDARY outcome

Timeframe: At Days 182 and 364

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=72 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=68 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=69 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease Flu A/California/7/2009, Day 364	63.9 Titers Interval 48.8 to 83.7	75.7 Titers Interval 59.8 to 96.0	81.3 Titers Interval 58.6 to 112.7	123.7 Titers Interval 95.2 to 160.8
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease Flu A/California/7/2009, Day 182	102.7 Titers Interval 79.4 to 132.9	147.5 Titers Interval 120.9 to 180.0	128.3 Titers Interval 94.9 to 173.3	226.3 Titers Interval 183.5 to 279.1

SECONDARY outcome

Timeframe: At Days 21 and 42

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=71 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted (SCR) Subjects for HI Antibodies Flu A/CAL/7/09, Day 21	71 Participants	62 Participants	65 Participants	61 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies Flu A/CAL/7/09, Day 42	68 Participants	62 Participants	65 Participants	62 Participants

SECONDARY outcome

Timeframe: At Days 182 and 364

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=72 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=68 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=69 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of SCR Subjects for HI Antibodies Flu A/CAL/7/09, Day 182	60 Participants	63 Participants	55 Participants	64 Participants
Number of SCR Subjects for HI Antibodies Flu A/CAL/7/09, Day 364	43 Participants	49 Participants	41 Participants	50 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.

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=71 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/CAL/7/09, Day 0	6 Participants	4 Participants	6 Participants	2 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/CAL/7/09, Day 21	73 Participants	64 Participants	67 Participants	62 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/CAL/7/09, Day 42	71 Participants	64 Participants	68 Participants	62 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.

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=72 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=68 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=69 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/CAL/7/09, Day 182	63 Participants	66 Participants	60 Participants	65 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Flu A/CAL/7/09, Day 364	47 Participants	54 Participants	48 Participants	53 Participants

SECONDARY outcome

Timeframe: At Days 21 and 42

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=64 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=71 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=63 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 21	37.4 Fold increase Interval 28.8 to 48.6	41.8 Fold increase Interval 31.5 to 55.3	38.0 Fold increase Interval 28.3 to 51.0	47.7 Fold increase Interval 35.7 to 63.7
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 42	26.2 Fold increase Interval 20.2 to 33.9	58.7 Fold increase Interval 44.6 to 77.3	30.1 Fold increase Interval 22.6 to 40.0	82.5 Fold increase Interval 66.4 to 102.5

SECONDARY outcome

Timeframe: At Days 182 and 364

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=72 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=68 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=69 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=65 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 182	12.1 Fold increase Interval 9.6 to 15.3	18.9 Fold increase Interval 15.3 to 23.5	14.3 Fold increase Interval 10.6 to 19.2	25.6 Fold increase Interval 20.9 to 31.5
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	7.6 Fold increase Interval 6.0 to 9.8	9.5 Fold increase Interval 7.6 to 11.9	8.9 Fold increase Interval 6.4 to 12.5	13.5 Fold increase Interval 10.7 to 17.0

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=73 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=75 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	71 Participants	62 Participants	69 Participants	66 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	2 Participants	2 Participants	1 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	1 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	4 Participants	4 Participants	3 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	0 Participants	61 Participants	0 Participants	59 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	0 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	0 Participants	3 Participants	0 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	0 Participants	5 Participants	0 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	71 Participants	67 Participants	69 Participants	68 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	2 Participants	2 Participants	1 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	1 Participants	3 Participants	4 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	4 Participants	7 Participants	3 Participants	11 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=71 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=67 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=69 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=68 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Days With Solicited Local Symptoms Redness, Dose 1	5.0 Days Interval 5.0 to 5.0	2.0 Days Interval 2.0 to 2.0	1.5 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 2.0
Number of Days With Solicited Local Symptoms Pain, Dose 1	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 3.0 to 4.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms Pain, Dose 2	—	3.0 Days Interval 2.0 to 3.0	—	3.0 Days Interval 2.0 to 3.0
Number of Days With Solicited Local Symptoms Pain, Overall/dose	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 3.0 to 4.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms Redness, Dose 2	—	2.0 Days Interval 1.0 to 5.0	—	4.0 Days Interval 2.0 to 5.0
Number of Days With Solicited Local Symptoms Redness, Overall/dose	5.0 Days Interval 5.0 to 5.0	2.0 Days Interval 1.5 to 3.5	1.5 Days Interval 1.0 to 3.0	3.0 Days Interval 2.0 to 4.5
Number of Days With Solicited Local Symptoms Swelling, Dose 1	4.0 Days Interval 3.0 to 5.0	3.0 Days Interval 2.0 to 3.5	1.0 Days Interval 1.0 to 5.0	3.0 Days Interval 2.0 to 5.0
Number of Days With Solicited Local Symptoms Swelling, Dose 2	—	3.0 Days Interval 2.0 to 3.0	—	2.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms Swelling, Overall/dose	4.0 Days Interval 3.0 to 5.0	3.0 Days Interval 2.0 to 3.0	1.0 Days Interval 1.0 to 5.0	2.5 Days Interval 2.0 to 4.0

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.

Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature \> 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=73 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=75 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	19 Participants	30 Participants	19 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	1 Participants	2 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	17 Participants	22 Participants	17 Participants	29 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	25 Participants	22 Participants	21 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	8 Participants	16 Participants	10 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	0 Participants	2 Participants	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	18 Participants	17 Participants	15 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 1	13 Participants	14 Participants	9 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 1	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 1	13 Participants	12 Participants	6 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	26 Participants	22 Participants	25 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	24 Participants	20 Participants	17 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	9 Participants	19 Participants	12 Participants	29 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	0 Participants	29 Participants	0 Participants	33 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	7 Participants	9 Participants	6 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 1	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	5 Participants	4 Participants	5 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	2 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	2 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	0 Participants	2 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	0 Participants	27 Participants	0 Participants	26 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	0 Participants	24 Participants	0 Participants	32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	0 Participants	2 Participants	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	0 Participants	17 Participants	0 Participants	26 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 2	0 Participants	15 Participants	0 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 2	0 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 2	0 Participants	15 Participants	0 Participants	19 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	0 Participants	21 Participants	0 Participants	26 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	0 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	0 Participants	21 Participants	0 Participants	26 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	0 Participants	21 Participants	0 Participants	21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	0 Participants	2 Participants	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	0 Participants	21 Participants	0 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	0 Participants	10 Participants	0 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	0 Participants	9 Participants	0 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	0 Participants	4 Participants	0 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	0 Participants	4 Participants	0 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	19 Participants	43 Participants	19 Participants	43 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	1 Participants	4 Participants	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	17 Participants	36 Participants	17 Participants	38 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	25 Participants	36 Participants	21 Participants	43 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	0 Participants	4 Participants	0 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	18 Participants	26 Participants	15 Participants	36 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Across doses	13 Participants	23 Participants	9 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Across doses	1 Participants	2 Participants	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Across doses	13 Participants	22 Participants	6 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	26 Participants	35 Participants	25 Participants	37 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	1 Participants	2 Participants	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	24 Participants	33 Participants	17 Participants	37 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	9 Participants	33 Participants	12 Participants	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	0 Participants	2 Participants	1 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	8 Participants	30 Participants	10 Participants	35 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	7 Participants	17 Participants	6 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	0 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	5 Participants	13 Participants	5 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	2 Participants	5 Participants	2 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	2 Participants	5 Participants	2 Participants	6 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=73 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=74 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=75 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Days With Solicited General Symptoms Temperature, Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0
Number of Days With Solicited General Symptoms Fatigue, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Fatigue, 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 Fatigue, Overall/dose	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Headache, Dose 1	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Headache, Dose 2	—	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 Headache, Overall/dose	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Joint pain, Dose 1	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 2.0 to 4.0	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, 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 Joint pain, Overall/dose	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 2.0 to 3.0	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 Muscle aches, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 3.0
Number of Days With Solicited General Symptoms Muscle aches, Dose 2	—	2.0 Days Interval 1.0 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	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 Sweating, Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	4.0 Days Interval 2.0 to 5.0	2.0 Days Interval 1.0 to 2.5
Number of Days With Solicited General Symptoms Sweating, 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 Sweating, Overall/dose	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0	4.0 Days Interval 2.0 to 5.0	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 2.0	1.5 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 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 Shivering, Overall/dose	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Temperature, Dose 2	—	1.5 Days Interval 1.0 to 2.5	—	1.0 Days Interval 1.0 to 1.0
Number of Days With Solicited General Symptoms Temperature, Overall/dose	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0

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 subjects with at least one vaccine administration documented.

Any pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Related pIMD was defined as an event assessed by the investigator as possibly related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=73 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=75 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Potential Immune-mediated Diseases (pIMDs) Any	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Potential Immune-mediated Diseases (pIMDs) Related	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=73 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=75 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s), Days 0-20	17 Participants	20 Participants	28 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s), Days 0-20	2 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s), Days 0-20	5 Participants	13 Participants	5 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s), up to Day 84	0 Participants	30 Participants	0 Participants	35 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s), up to Day 84	0 Participants	7 Participants	0 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s), up to Day 84	0 Participants	15 Participants	0 Participants	7 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

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

Outcome measures

Outcome measures
Measure	GSK2340272A New 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=73 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=76 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=75 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Serious Adverse Events (SAEs)	7 Participants	2 Participants	3 Participants	5 Participants

Adverse Events

GSK2340272A New 1D Group

Serious events: 7 serious events

Other events: 72 other events

Deaths: 0 deaths

GSK2340272A New 2D Group

Serious events: 2 serious events

Other events: 70 other events

Deaths: 0 deaths

GSK2340272A INI 1D Group

Serious events: 3 serious events

Other events: 71 other events

Deaths: 0 deaths

GSK2340272A INI 2D Group

Serious events: 5 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK2340272A New 1D Group n=76 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A New 2D Group n=73 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340272A INI 1D Group n=76 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.	GSK2340272A INI 2D Group n=75 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Musculoskeletal and connective tissue disorders Arthralgia	17.1% 13/76 • Number of events 13 • 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).	31.5% 23/73 • Number of events 31 • 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).	11.8% 9/76 • 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).	37.3% 28/75 • 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 Chills	11.8% 9/76 • 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).	45.2% 33/73 • Number of events 40 • 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).	15.8% 12/76 • Number of events 12 • 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).	53.3% 40/75 • Number of events 50 • 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	1.3% 1/76 • Number of events 1 • 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).	4.1% 3/73 • Number of events 4 • 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).	5.3% 4/76 • Number of events 4 • 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).	5.3% 4/75 • Number of events 4 • 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	25.0% 19/76 • Number of events 19 • 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).	58.9% 43/73 • Number of events 61 • 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).	25.0% 19/76 • Number of events 19 • 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).	57.3% 43/75 • Number of events 65 • 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	32.9% 25/76 • Number of events 26 • 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).	52.1% 38/73 • Number of events 56 • 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).	30.3% 23/76 • Number of events 27 • 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).	60.0% 45/75 • 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).
Skin and subcutaneous tissue disorders Hyperhidrosis	9.2% 7/76 • Number of events 7 • 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).	23.3% 17/73 • Number of events 19 • 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).	7.9% 6/76 • Number of events 6 • 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).	26.7% 20/75 • Number of events 22 • 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	34.2% 26/76 • Number of events 26 • 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).	47.9% 35/73 • Number of events 43 • 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).	32.9% 25/76 • Number of events 25 • 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).	50.7% 38/75 • Number of events 55 • 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	25.0% 19/76 • Number of events 19 • 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).	9.6% 7/73 • Number of events 7 • 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).	10.5% 8/76 • 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).	14.7% 11/75 • 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).
Gastrointestinal disorders Nausea	0.00% 0/76 • 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).	5.5% 4/73 • Number of events 4 • 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).	1.3% 1/76 • Number of events 1 • 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% 0/75 • 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).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.3% 4/76 • Number of events 4 • 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% 0/73 • 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% 0/76 • 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).	2.7% 2/75 • Number of events 2 • 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	93.4% 71/76 • Number of events 71 • 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).	91.8% 67/73 • Number of events 123 • 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).	90.8% 69/76 • Number of events 69 • 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).	90.7% 68/75 • Number of events 125 • 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 Pyrexia	3.9% 3/76 • Number of events 3 • 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).	12.3% 9/73 • Number of events 10 • 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).	3.9% 3/76 • Number of events 3 • 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).	20.0% 15/75 • Number of events 17 • 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	5.3% 4/76 • Number of events 4 • 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).	9.6% 7/73 • 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).	3.9% 3/76 • Number of events 3 • 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).	13.3% 10/75 • Number of events 13 • 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	1.3% 1/76 • Number of events 1 • 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).	4.1% 3/73 • Number of events 3 • 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).	1.3% 1/76 • Number of events 1 • 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).	8.0% 6/75 • Number of events 7 • 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