Trial Outcomes & Findings for Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1) (NCT NCT00979407)

NCT ID: NCT00979407

Last Updated: 2018-08-06

Results Overview

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 greater than or equal to (≥) 1:10.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 336 participants
• Primary outcome timeframe: At Day 21
• Results posted on: 2018-08-06

Participant Flow

Out of 336 subjects enrolled in the study, 2 subjects did not receive any vaccination.

Participant milestones

Measure	GSK2340272A GROUP Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	167	167
Overall Study COMPLETED	161	160
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Measure	GSK2340272A GROUP Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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 Withdrawal by Subject	3	4
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)

Baseline characteristics by cohort

Measure	GSK2340272A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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=334 Participants Total of all reporting groups
Age, Continuous	40.1 Years STANDARD_DEVIATION 11.65 • n=5 Participants	39.7 Years STANDARD_DEVIATION 11.98 • n=7 Participants	39.90 Years STANDARD_DEVIATION 11.80 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	77 Participants n=7 Participants	164 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	90 Participants n=7 Participants	170 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage / african american	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - arabic / north african heritage	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - caucasian / european heritage	165 Participants n=5 Participants	161 Participants n=7 Participants	326 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 21

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

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

Outcome measures

Measure	GSK2340272A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	383.6 Titers Interval 327.2 to 449.7	339.1 Titers Interval 285.4 to 403.0

SECONDARY outcome

Timeframe: At Days 21 and 42

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

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

Outcome measures

Measure	GSK2340272A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	151 Participants	145 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies Flu A/CAL/7/09, Day 42	154 Participants	153 Participants

SECONDARY outcome

Timeframe: At Days 182 and 364

Population: The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component 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

Measure	GSK2340272A GROUP n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=154 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	144 Participants	141 Participants
Number of SCR Subjects for HI Antibodies Flu A/CAL/7/09, Day 364	109 Participants	106 Participants

SECONDARY outcome

Timeframe: At Days 0 and 42

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

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

Outcome measures

Measure	GSK2340272A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 0	9.5 Titers Interval 8.1 to 11.2	10.7 Titers Interval 9.1 to 12.7
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 42	599.8 Titers Interval 532.3 to 675.9	678.3 Titers Interval 599.3 to 767.6

SECONDARY outcome

Timeframe: At Days 182 and 364

Population: The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component 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

Measure	GSK2340272A GROUP n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=154 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 182	202.5 Titers Interval 173.1 to 236.9	233.0 Titers Interval 196.0 to 276.9
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 364	96.7 Titers Interval 81.2 to 115.2	107.6 Titers Interval 89.2 to 129.7

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

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

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.

Outcome measures

Measure	GSK2340272A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	19 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 21	155 Participants	151 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	155 Participants	155 Participants

SECONDARY outcome

Timeframe: At Days 182 and 364

Population: The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component 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

Measure	GSK2340272A GROUP n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=154 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	151 Participants	150 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	121 Participants	121 Participants

SECONDARY outcome

Timeframe: At Days 21 and 42

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

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

Measure	GSK2340272A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	40.3 Fold increase Interval 33.2 to 49.0	31.6 Fold increase Interval 26.0 to 38.4
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	63.0 Fold increase Interval 52.2 to 76.1	63.2 Fold increase Interval 52.6 to 75.9

SECONDARY outcome

Timeframe: At Days 182 and 364

Population: The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component 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

Measure	GSK2340272A GROUP n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=154 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	22.0 Fold increase Interval 18.5 to 26.1	21.7 Fold increase Interval 18.1 to 25.9
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	11.0 Fold increase Interval 9.2 to 13.2	11.0 Fold increase Interval 9.1 to 13.3

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects, who had their symptom sheets 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

Measure	GSK2340272A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	148 Participants	144 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	6 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	25 Participants	19 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	32 Participants	29 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	139 Participants	137 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	5 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	18 Participants	17 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	17 Participants	21 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	153 Participants	151 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	8 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	35 Participants	28 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	36 Participants	36 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	2 Participants	0 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	GSK2340272A GROUP n=287 Doses with the symptom Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=281 Doses with the symptom Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Days With Solicited Local Symptoms Pain, Post-Dose 1	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms Pain, Post-Dose 2	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0
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
Number of Days With Solicited Local Symptoms Redness, Post-Dose 1	3.0 Days Interval 2.0 to 6.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms Redness, Post-Dose 2	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 2.0 to 3.0
Number of Days With Solicited Local Symptoms Redness, Overall/dose	3.0 Days Interval 2.0 to 5.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms Swelling, Post-Dose 1	3.0 Days Interval 2.0 to 5.5	2.0 Days Interval 1.0 to 5.0
Number of Days With Solicited Local Symptoms Swelling, Post-Dose 2	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 4.0
Number of Days With Solicited Local Symptoms Swelling, Overall/dose	3.0 Days Interval 2.0 to 5.0	2.0 Days Interval 1.0 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 vaccinated subjects, who had their symptom sheets 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 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

Measure	GSK2340272A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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 Grade 3 Temperature, Dose 1	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	60 Participants	55 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	54 Participants	54 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	55 Participants	48 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	46 Participants	44 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 1	37 Participants	38 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 1	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 1	33 Participants	37 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	57 Participants	81 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	55 Participants	79 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	34 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	32 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	13 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 1	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	12 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	2 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	2 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	61 Participants	60 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	59 Participants	59 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	57 Participants	51 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	53 Participants	46 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 2	34 Participants	47 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 2	5 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 2	33 Participants	45 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	64 Participants	71 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	63 Participants	70 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	37 Participants	35 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	5 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	37 Participants	32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	24 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	23 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	11 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	11 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	92 Participants	79 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	6 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	87 Participants	78 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	83 Participants	73 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	6 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	74 Participants	69 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Across doses	53 Participants	66 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Across doses	5 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Across doses	49 Participants	64 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	85 Participants	104 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	6 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	83 Participants	102 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	57 Participants	47 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	5 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	56 Participants	45 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	28 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	5 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	27 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	12 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	3 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	12 Participants	11 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	GSK2340272A GROUP n=121 Doses with the symptom Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=152 Doses with the symptom Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Days With Solicited General Symptoms Fatigue, Post-Dose 1	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 4.0
Number of Days With Solicited General Symptoms Fatigue, Post-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 Fatigue, Overall/dose	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, 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 Headache, Post-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	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, Post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Joint pain, Post-Dose 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 1.0 to 3.0
Number of Days With Solicited General Symptoms Muscle aches, Post-Dose 1	2.0 Days Interval 2.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Muscle aches, 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 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 1.0	1.0 Days Interval 1.0 to 1.0
Number of Days With Solicited General Symptoms Sweating, Post-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 Sweating, 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 Shivering, Post-Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Shivering, Post-Dose 2	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Shivering, Overall/dose	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 Temperature, Post-Dose 1	3.0 Days Interval 1.0 to 5.0	1.0 Days Interval 1.0 to 1.0
Number of Days With Solicited General Symptoms Temperature, Post-Dose 2	1.0 Days Interval 1.0 to 1.0	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Temperature, Overall/dose	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: From Day 0 up to Day 42

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

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

Outcome measures

Measure	GSK2340272A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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)	0 Participants	0 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.

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

Outcome measures

Measure	GSK2340272A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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 pIMDs	1 Participants	0 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

Measure	GSK2340272A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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 Adverse Event of Special Interest (AESIs)	0 Participants	0 Participants

SECONDARY outcome

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

Measure	GSK2340272A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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) Grade 3 AE(s), up to Day 84	16 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s), up to Day 84	20 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s), Days 0-20	37 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s), Days 0-20	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s), Days 0-20	17 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s), up to Day 84	68 Participants	71 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

Measure	GSK2340272A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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)	9 Participants	11 Participants

Adverse Events

GSK2340272A GROUP

Serious events: 9 serious events

Other events: 157 other events

Deaths: 0 deaths

GSK2340274A GROUP

Serious events: 11 serious events

Other events: 159 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK2340272A GROUP n=167 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Cardiac disorders Acute coronary syndrome	0.60% 1/167 • 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% 0/167 • 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).
Endocrine disorders Thyroid mass	0.60% 1/167 • 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% 0/167 • 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 Anal fissure	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Gastrointestinal disorders Gastritis	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Gastrointestinal disorders Inguinal hernia	0.60% 1/167 • 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% 0/167 • 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 Appendicitis	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Infections and infestations Perirectal abscess	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Infections and infestations Pyelonephritis	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Injury, poisoning and procedural complications Intervertebral disc injury	0.60% 1/167 • 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% 0/167 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Injury, poisoning and procedural complications Testicular injury	0.60% 1/167 • 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% 0/167 • 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).
Metabolism and nutrition disorders Hypercholesterolaemia	0.60% 1/167 • 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% 0/167 • 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 Back pain	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Nervous system disorders Amnesia	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	0.60% 1/167 • 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% 0/167 • 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).
Psychiatric disorders Adjustment disorder	0.60% 1/167 • 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% 0/167 • 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).
Psychiatric disorders Suicide attempt	0.60% 1/167 • 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% 0/167 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Renal and urinary disorders Nephrolithiasis	0.60% 1/167 • 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).	0.60% 1/167 • 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).
Reproductive system and breast disorders Ovarian cyst	0.60% 1/167 • 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% 0/167 • 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 Pneumonia aspiration	0.60% 1/167 • 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% 0/167 • 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 Pulmonary embolism	0.00% 0/167 • 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).	0.60% 1/167 • 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).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.60% 1/167 • 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% 0/167 • 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).

Other adverse events

Measure	GSK2340272A GROUP n=167 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2340274A GROUP n=167 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A 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	31.7% 53/167 • 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).	39.5% 66/167 • Number of events 85 • 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	34.1% 57/167 • 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).	28.1% 47/167 • Number of events 59 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Skin and subcutaneous tissue disorders Erythema	21.0% 35/167 • 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).	16.8% 28/167 • Number of events 36 • 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	55.1% 92/167 • Number of events 121 • 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).	47.3% 79/167 • Number of events 116 • 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	49.7% 83/167 • Number of events 120 • 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% 80/167 • Number of events 116 • 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	16.8% 28/167 • Number of events 37 • 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).	16.8% 28/167 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Musculoskeletal and connective tissue disorders Myalgia	50.9% 85/167 • Number of events 121 • 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).	62.3% 104/167 • Number of events 152 • 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	7.8% 13/167 • Number of events 15 • 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).	5.4% 9/167 • 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).
General disorders Pain	91.6% 153/167 • Number of events 287 • 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).	90.4% 151/167 • Number of events 281 • 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	7.2% 12/167 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	6.0% 10/167 • 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).
Infections and infestations Rhinitis	5.4% 9/167 • 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).	2.4% 4/167 • 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 Swelling	21.6% 36/167 • Number of events 49 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).	21.6% 36/167 • 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).

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