Trial Outcomes & Findings for Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults (NCT NCT00621322)

Last Updated: 2018-08-24

Results Overview

Assessed solicited local symptoms included 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 50 millimeters (mm) of injection site. Relationship analysis was not performed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

180 participants

Primary outcome timeframe

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

Results posted on

2018-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Study STARTED	10	10	40	40	40	40
Overall Study COMPLETED	9	10	38	37	39	36
Overall Study NOT COMPLETED	1	0	2	3	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Study Lost to Follow-up	0	0	0	1	0
Overall Study Physician Decision	0	1	1	0	0
Overall Study Withdrawal by Subject	0	0	1	0	2
Overall Study Migrated/moved from study area	1	1	1	0	2

Baseline Characteristics

Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	Total n=180 Participants Total of all reporting groups
Age, Continuous	32.1 Years STANDARD_DEVIATION 8.10 • n=5 Participants	36.0 Years STANDARD_DEVIATION 5.14 • n=7 Participants	30.6 Years STANDARD_DEVIATION 9.14 • n=5 Participants	33.5 Years STANDARD_DEVIATION 8.73 • n=4 Participants	30.6 Years STANDARD_DEVIATION 9.17 • n=21 Participants	31.5 Years STANDARD_DEVIATION 8.83 • n=10 Participants	31.92 Years STANDARD_DEVIATION 8.67 • n=115 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	33 Participants n=5 Participants	36 Participants n=4 Participants	31 Participants n=21 Participants	26 Participants n=10 Participants	142 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants	14 Participants n=10 Participants	38 Participants n=115 Participants

PRIMARY 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 from whom data were available.

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Across	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Across	1 Subjects	2 Subjects	7 Subjects	6 Subjects	6 Subjects	6 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Across	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Across	1 Subjects	1 Subjects	10 Subjects	10 Subjects	12 Subjects	12 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Across	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 1	8 Subjects	3 Subjects	35 Subjects	33 Subjects	33 Subjects	32 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 1	1 Subjects	2 Subjects	7 Subjects	3 Subjects	4 Subjects	3 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 1	0 Subjects	0 Subjects	8 Subjects	6 Subjects	7 Subjects	6 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 2	7 Subjects	4 Subjects	33 Subjects	32 Subjects	36 Subjects	33 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 2	0 Subjects	1 Subjects	0 Subjects	5 Subjects	4 Subjects	5 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 2	1 Subjects	1 Subjects	5 Subjects	5 Subjects	7 Subjects	8 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Across	9 Subjects	5 Subjects	38 Subjects	37 Subjects	37 Subjects	36 Subjects

PRIMARY 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 from whom data were available.

Assessed solicited general symptoms included fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Number of Subjects With Solicited General Symptoms Any Fatigue, Dose 1	1 Subjects	1 Subjects	4 Subjects	5 Subjects	7 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Dose 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue, Dose 1	0 Subjects	0 Subjects	1 Subjects	3 Subjects	4 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Any Gastro, Dose 1	2 Subjects	3 Subjects	5 Subjects	3 Subjects	5 Subjects	7 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastro, Dose 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Gastro, Dose 1	2 Subjects	0 Subjects	3 Subjects	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Any Headache, Dose 1	4 Subjects	4 Subjects	11 Subjects	16 Subjects	15 Subjects	19 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Dose 1	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Headache, Dose 1	2 Subjects	0 Subjects	7 Subjects	8 Subjects	7 Subjects	10 Subjects
Number of Subjects With Solicited General Symptoms Any Malaise, Dose 1	3 Subjects	3 Subjects	9 Subjects	13 Subjects	10 Subjects	18 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Malaise, Dose 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Malaise, Dose 1	2 Subjects	0 Subjects	7 Subjects	8 Subjects	8 Subjects	16 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia, Dose 1	1 Subjects	3 Subjects	14 Subjects	10 Subjects	13 Subjects	14 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Dose 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia, Dose 1	1 Subjects	1 Subjects	9 Subjects	6 Subjects	11 Subjects	13 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature, Dose 1	2 Subjects	1 Subjects	3 Subjects	2 Subjects	3 Subjects	9 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Related Temperature, Dose 1	1 Subjects	0 Subjects	3 Subjects	1 Subjects	2 Subjects	8 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue, Dose 2	1 Subjects	1 Subjects	5 Subjects	6 Subjects	8 Subjects	8 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Dose 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue, Dose 2	1 Subjects	1 Subjects	4 Subjects	3 Subjects	6 Subjects	7 Subjects
Number of Subjects With Solicited General Symptoms Any Gastro, Dose 2	1 Subjects	1 Subjects	5 Subjects	7 Subjects	8 Subjects	9 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastro, Dose 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Gastro, Dose 2	0 Subjects	0 Subjects	1 Subjects	1 Subjects	7 Subjects	8 Subjects
Number of Subjects With Solicited General Symptoms Any Headache, Dose 2	5 Subjects	3 Subjects	22 Subjects	20 Subjects	29 Subjects	26 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Dose 2	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Headache, Dose 2	1 Subjects	1 Subjects	13 Subjects	8 Subjects	24 Subjects	22 Subjects
Number of Subjects With Solicited General Symptoms Any Malaise, Dose 2	5 Subjects	1 Subjects	22 Subjects	21 Subjects	21 Subjects	25 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Malaise, Dose 2	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Malaise, Dose 2	4 Subjects	1 Subjects	21 Subjects	17 Subjects	21 Subjects	24 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia, Dose 2	3 Subjects	1 Subjects	18 Subjects	21 Subjects	23 Subjects	28 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Dose 2	0 Subjects	0 Subjects	1 Subjects	0 Subjects	2 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia, Dose 2	2 Subjects	1 Subjects	18 Subjects	20 Subjects	23 Subjects	28 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature, Dose 2	3 Subjects	0 Subjects	15 Subjects	8 Subjects	16 Subjects	27 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Subjects	0 Subjects	2 Subjects	0 Subjects	1 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Related Temperature, Dose 2	2 Subjects	0 Subjects	13 Subjects	7 Subjects	15 Subjects	27 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue, Across	2 Subjects	1 Subjects	7 Subjects	8 Subjects	13 Subjects	10 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Across	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue, Across	1 Subjects	1 Subjects	4 Subjects	6 Subjects	9 Subjects	8 Subjects
Number of Subjects With Solicited General Symptoms Any Gastro, Across	3 Subjects	3 Subjects	8 Subjects	9 Subjects	11 Subjects	10 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastro, Across	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Gastro, Across	2 Subjects	0 Subjects	4 Subjects	2 Subjects	8 Subjects	8 Subjects
Number of Subjects With Solicited General Symptoms Any Headache, Across	5 Subjects	6 Subjects	25 Subjects	27 Subjects	30 Subjects	26 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Across	1 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Headache, Across	3 Subjects	1 Subjects	18 Subjects	15 Subjects	24 Subjects	23 Subjects
Number of Subjects With Solicited General Symptoms Any Malaise, Across	5 Subjects	3 Subjects	23 Subjects	25 Subjects	23 Subjects	26 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Malaise, Across	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Malaise, Across	5 Subjects	1 Subjects	22 Subjects	21 Subjects	23 Subjects	26 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia, Across	3 Subjects	3 Subjects	25 Subjects	23 Subjects	24 Subjects	29 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Across	0 Subjects	0 Subjects	1 Subjects	0 Subjects	2 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia, Across	2 Subjects	2 Subjects	24 Subjects	22 Subjects	24 Subjects	29 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature, Across	5 Subjects	1 Subjects	17 Subjects	9 Subjects	17 Subjects	28 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature, Across	0 Subjects	0 Subjects	2 Subjects	0 Subjects	1 Subjects	4 Subjects
Number of Subjects With Solicited General Symptoms Related Temperature, Across	3 Subjects	0 Subjects	15 Subjects	7 Subjects	15 Subjects	28 Subjects

PRIMARY outcome

Timeframe: During the 30-day (Days 0-29) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

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	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Number of Subjects With Unsolicited Adverse Events (AEs) Any AEs	7 Subjects	9 Subjects	29 Subjects	33 Subjects	33 Subjects	27 Subjects
Number of Subjects With Unsolicited Adverse Events (AEs) Grade 3 AEs	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Unsolicited Adverse Events (AEs) Related AEs	0 Subjects	1 Subjects	7 Subjects	2 Subjects	5 Subjects	2 Subjects

PRIMARY outcome

Timeframe: During the entire study period (from Day 0 up to Day 210)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

Serious adverse events (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	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	0 Subjects	0 Subjects	2 Subjects	0 Subjects	2 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Number of Subjects With Different Biochemical and Haematological Levels RBC, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Normal	10 Subjects	9 Subjects	37 Subjects	31 Subjects	30 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Above	0 Subjects	1 Subjects	2 Subjects	9 Subjects	9 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Normal	10 Subjects	10 Subjects	40 Subjects	38 Subjects	38 Subjects	37 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Above	0 Subjects	0 Subjects	0 Subjects	1 Subjects	2 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Missing	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Normal	9 Subjects	9 Subjects	40 Subjects	38 Subjects	37 Subjects	38 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Above	1 Subjects	1 Subjects	0 Subjects	1 Subjects	3 Subjects	2 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Missing	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Normal	3 Subjects	10 Subjects	11 Subjects	18 Subjects	40 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Missing	7 Subjects	0 Subjects	29 Subjects	22 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Normal	9 Subjects	10 Subjects	38 Subjects	38 Subjects	39 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Below	1 Subjects	0 Subjects	2 Subjects	1 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Missing	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Normal	9 Subjects	8 Subjects	38 Subjects	38 Subjects	33 Subjects	34 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Below	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Above	1 Subjects	2 Subjects	0 Subjects	1 Subjects	7 Subjects	5 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Normal	10 Subjects	9 Subjects	38 Subjects	39 Subjects	37 Subjects	35 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Below	0 Subjects	1 Subjects	1 Subjects	1 Subjects	3 Subjects	4 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Normal	10 Subjects	8 Subjects	39 Subjects	39 Subjects	38 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Below	0 Subjects	2 Subjects	0 Subjects	1 Subjects	2 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Normal	9 Subjects	10 Subjects	38 Subjects	37 Subjects	39 Subjects	37 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Below	1 Subjects	0 Subjects	1 Subjects	3 Subjects	1 Subjects	2 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Normal	10 Subjects	9 Subjects	39 Subjects	40 Subjects	38 Subjects	38 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Below	0 Subjects	1 Subjects	0 Subjects	0 Subjects	2 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Normal	9 Subjects	10 Subjects	35 Subjects	36 Subjects	37 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Above	1 Subjects	0 Subjects	4 Subjects	4 Subjects	3 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Normal	10 Subjects	10 Subjects	39 Subjects	40 Subjects	40 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Normal	9 Subjects	7 Subjects	36 Subjects	35 Subjects	36 Subjects	35 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Below	1 Subjects	1 Subjects	2 Subjects	1 Subjects	2 Subjects	4 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Above	0 Subjects	2 Subjects	1 Subjects	4 Subjects	2 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 7

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Number of Subjects With Different Biochemical and Haematological Levels NEU, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Normal	10 Subjects	10 Subjects	36 Subjects	32 Subjects	38 Subjects	34 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Below	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Above	0 Subjects	0 Subjects	2 Subjects	7 Subjects	2 Subjects	4 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Missing	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Normal	10 Subjects	10 Subjects	39 Subjects	36 Subjects	40 Subjects	37 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Above	0 Subjects	0 Subjects	0 Subjects	3 Subjects	0 Subjects	2 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Normal	2 Subjects	10 Subjects	1 Subjects	7 Subjects	40 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Missing	8 Subjects	0 Subjects	39 Subjects	33 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Normal	10 Subjects	10 Subjects	38 Subjects	36 Subjects	39 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Above	0 Subjects	0 Subjects	1 Subjects	3 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Normal	10 Subjects	6 Subjects	38 Subjects	38 Subjects	32 Subjects	31 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Above	0 Subjects	4 Subjects	1 Subjects	2 Subjects	8 Subjects	8 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Normal	10 Subjects	8 Subjects	37 Subjects	37 Subjects	34 Subjects	33 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Below	0 Subjects	2 Subjects	2 Subjects	3 Subjects	6 Subjects	6 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Normal	10 Subjects	7 Subjects	39 Subjects	38 Subjects	33 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Below	0 Subjects	3 Subjects	0 Subjects	2 Subjects	7 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Normal	10 Subjects	10 Subjects	38 Subjects	40 Subjects	40 Subjects	38 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Below	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Normal	10 Subjects	9 Subjects	39 Subjects	40 Subjects	38 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Below	0 Subjects	1 Subjects	0 Subjects	0 Subjects	2 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Normal	9 Subjects	10 Subjects	38 Subjects	40 Subjects	40 Subjects	38 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Above	1 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Normal	10 Subjects	9 Subjects	39 Subjects	40 Subjects	39 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Above	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Normal	8 Subjects	8 Subjects	33 Subjects	33 Subjects	34 Subjects	33 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Below	2 Subjects	1 Subjects	5 Subjects	5 Subjects	5 Subjects	6 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Above	0 Subjects	1 Subjects	1 Subjects	2 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Normal	9 Subjects	9 Subjects	33 Subjects	37 Subjects	31 Subjects	35 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Above	1 Subjects	1 Subjects	6 Subjects	3 Subjects	7 Subjects	4 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Missing	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects

PRIMARY outcome

Timeframe: At Day 30

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Number of Subjects With Different Biochemical and Haematological Levels NEU, Normal	9 Subjects	10 Subjects	38 Subjects	39 Subjects	38 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Normal	9 Subjects	9 Subjects	38 Subjects	36 Subjects	36 Subjects	38 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Above	1 Subjects	1 Subjects	1 Subjects	2 Subjects	3 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Missing	0 Subjects	0 Subjects	1 Subjects	2 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Normal	10 Subjects	10 Subjects	38 Subjects	35 Subjects	37 Subjects	37 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Above	0 Subjects	0 Subjects	1 Subjects	3 Subjects	3 Subjects	2 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Missing	0 Subjects	0 Subjects	1 Subjects	2 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Normal	4 Subjects	10 Subjects	5 Subjects	13 Subjects	39 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Missing	6 Subjects	0 Subjects	35 Subjects	27 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Normal	10 Subjects	9 Subjects	39 Subjects	37 Subjects	36 Subjects	37 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	3 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Above	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Missing	0 Subjects	0 Subjects	1 Subjects	2 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Normal	8 Subjects	8 Subjects	37 Subjects	35 Subjects	28 Subjects	30 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Below	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Above	1 Subjects	2 Subjects	1 Subjects	5 Subjects	11 Subjects	9 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Missing	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Normal	8 Subjects	7 Subjects	36 Subjects	34 Subjects	34 Subjects	35 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Below	1 Subjects	3 Subjects	3 Subjects	5 Subjects	5 Subjects	4 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Above	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Missing	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Normal	8 Subjects	7 Subjects	38 Subjects	35 Subjects	33 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Below	1 Subjects	3 Subjects	1 Subjects	4 Subjects	6 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Above	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Missing	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Normal	9 Subjects	9 Subjects	38 Subjects	40 Subjects	39 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Below	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Missing	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Normal	9 Subjects	10 Subjects	39 Subjects	40 Subjects	39 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Missing	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Above	0 Subjects	0 Subjects	1 Subjects	1 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Missing	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Normal	9 Subjects	10 Subjects	39 Subjects	40 Subjects	38 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Missing	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Normal	9 Subjects	8 Subjects	36 Subjects	36 Subjects	36 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Below	0 Subjects	1 Subjects	2 Subjects	2 Subjects	2 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Above	0 Subjects	1 Subjects	1 Subjects	2 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Missing	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Normal	9 Subjects	8 Subjects	35 Subjects	37 Subjects	33 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	3 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Above	0 Subjects	2 Subjects	4 Subjects	3 Subjects	3 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Missing	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects

PRIMARY outcome

Timeframe: At Day 37

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Number of Subjects With Different Biochemical and Haematological Levels ALT, Normal	9 Subjects	10 Subjects	37 Subjects	36 Subjects	34 Subjects	35 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Above	1 Subjects	0 Subjects	2 Subjects	3 Subjects	6 Subjects	4 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Normal	10 Subjects	10 Subjects	37 Subjects	38 Subjects	37 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Above	0 Subjects	0 Subjects	2 Subjects	1 Subjects	3 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Normal	4 Subjects	10 Subjects	10 Subjects	15 Subjects	40 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Missing	6 Subjects	0 Subjects	0 Subjects	25 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Normal	10 Subjects	9 Subjects	38 Subjects	39 Subjects	38 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Below	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Normal	6 Subjects	7 Subjects	35 Subjects	36 Subjects	33 Subjects	33 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Below	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Above	4 Subjects	3 Subjects	3 Subjects	3 Subjects	7 Subjects	6 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Normal	8 Subjects	7 Subjects	34 Subjects	32 Subjects	35 Subjects	35 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Below	2 Subjects	3 Subjects	5 Subjects	6 Subjects	5 Subjects	4 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Above	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Normal	9 Subjects	6 Subjects	36 Subjects	34 Subjects	36 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Below	1 Subjects	4 Subjects	3 Subjects	4 Subjects	4 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Below	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Above	1 Subjects	3 Subjects	7 Subjects	3 Subjects	7 Subjects	5 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Above	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Normal	10 Subjects	10 Subjects	38 Subjects	38 Subjects	39 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Below	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Above	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Normal	10 Subjects	10 Subjects	39 Subjects	38 Subjects	39 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Above	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Normal	10 Subjects	10 Subjects	38 Subjects	38 Subjects	39 Subjects	37 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Below	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Above	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Normal	10 Subjects	9 Subjects	37 Subjects	39 Subjects	40 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Above	0 Subjects	1 Subjects	2 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Normal	9 Subjects	8 Subjects	34 Subjects	35 Subjects	36 Subjects	33 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Below	1 Subjects	1 Subjects	5 Subjects	2 Subjects	3 Subjects	6 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Above	0 Subjects	1 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Normal	9 Subjects	7 Subjects	32 Subjects	35 Subjects	33 Subjects	34 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects

PRIMARY outcome

Timeframe: At Day 60

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Number of Subjects With Different Biochemical and Haematological Levels ALT, Normal	9 Subjects	9 Subjects	38 Subjects	37 Subjects	38 Subjects	34 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Above	1 Subjects	1 Subjects	1 Subjects	2 Subjects	2 Subjects	5 Subjects
Number of Subjects With Different Biochemical and Haematological Levels ALT, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Normal	9 Subjects	9 Subjects	38 Subjects	37 Subjects	38 Subjects	37 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Above	1 Subjects	1 Subjects	1 Subjects	2 Subjects	2 Subjects	2 Subjects
Number of Subjects With Different Biochemical and Haematological Levels AST, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Normal	10 Subjects	10 Subjects	38 Subjects	39 Subjects	40 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels BAS, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Normal	10 Subjects	9 Subjects	38 Subjects	37 Subjects	39 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Below	0 Subjects	1 Subjects	1 Subjects	2 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels CREA, Missing	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Normal	7 Subjects	7 Subjects	34 Subjects	36 Subjects	32 Subjects	31 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Above	3 Subjects	3 Subjects	4 Subjects	3 Subjects	8 Subjects	8 Subjects
Number of Subjects With Different Biochemical and Haematological Levels EOS, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Normal	9 Subjects	8 Subjects	33 Subjects	36 Subjects	36 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Below	1 Subjects	2 Subjects	5 Subjects	2 Subjects	4 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Above	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hct, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Normal	9 Subjects	8 Subjects	35 Subjects	36 Subjects	37 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Below	1 Subjects	2 Subjects	3 Subjects	2 Subjects	3 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Above	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels Hgb, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Normal	10 Subjects	8 Subjects	38 Subjects	39 Subjects	38 Subjects	37 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Below	0 Subjects	2 Subjects	0 Subjects	0 Subjects	2 Subjects	2 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels LYM, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Normal	10 Subjects	9 Subjects	37 Subjects	39 Subjects	40 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Below	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Above	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels MON, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Normal	9 Subjects	8 Subjects	38 Subjects	39 Subjects	37 Subjects	37 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Above	1 Subjects	2 Subjects	0 Subjects	0 Subjects	3 Subjects	2 Subjects
Number of Subjects With Different Biochemical and Haematological Levels NEU, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Normal	10 Subjects	9 Subjects	38 Subjects	38 Subjects	40 Subjects	39 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Above	0 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels PLA, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Normal	9 Subjects	8 Subjects	36 Subjects	35 Subjects	37 Subjects	36 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Below	1 Subjects	1 Subjects	2 Subjects	3 Subjects	2 Subjects	3 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Above	0 Subjects	1 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects
Number of Subjects With Different Biochemical and Haematological Levels RBC, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Normal	8 Subjects	7 Subjects	34 Subjects	37 Subjects	36 Subjects	31 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Below	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Above	2 Subjects	3 Subjects	4 Subjects	2 Subjects	3 Subjects	7 Subjects
Number of Subjects With Different Biochemical and Haematological Levels WBC, Missing	0 Subjects	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects

SECONDARY outcome

Timeframe: At Day 0, 30, 60 and 210

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines CD4-All Doubles, D0 [N=9;9;38;34;40;39]	173.0 T cells/million cells Interval 94.0 to 466.0	293.0 T cells/million cells Interval 213.0 to 853.0	200.0 T cells/million cells Interval 87.0 to 537.0	241.0 T cells/million cells Interval 147.0 to 547.0	263.5 T cells/million cells Interval 80.5 to 528.5	312.0 T cells/million cells Interval 133.0 to 488.0
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines CD4-All Doubles, D30 [N=10;10;38;36;39;37]	245.5 T cells/million cells Interval 80.0 to 387.0	1013.5 T cells/million cells Interval 491.0 to 3227.0	2833.0 T cells/million cells Interval 1440.0 to 5120.0	1653.5 T cells/million cells Interval 886.5 to 3587.0	2653.0 T cells/million cells Interval 1480.0 to 4826.0	3280.0 T cells/million cells Interval 2267.0 to 6928.0
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines CD4-All Doubles, D60 [N=10;9;38;36;38;37]	139.5 T cells/million cells Interval 27.0 to 187.0	2133.0 T cells/million cells Interval 640.0 to 3240.0	6307.0 T cells/million cells Interval 3560.0 to 9307.0	3855.5 T cells/million cells Interval 2353.5 to 5220.0	4880.0 T cells/million cells Interval 3147.0 to 6853.0	5133.0 T cells/million cells Interval 3227.0 to 7733.0
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines CD4-All Doubles, D210 [N=9;7;37;32;35;34]	106.0 T cells/million cells Interval 91.0 to 414.0	1426.0 T cells/million cells Interval 949.0 to 2814.0	3826.0 T cells/million cells Interval 2467.0 to 5907.0	2486.5 T cells/million cells Interval 1660.0 to 4075.0	3240.0 T cells/million cells Interval 2520.0 to 5360.0	3633.5 T cells/million cells Interval 2733.0 to 5253.0
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines CD8-All Doubles, D0 [N=9;9;38;34;40;39]	1.0 T cells/million cells Interval 1.0 to 65.0	5.0 T cells/million cells Interval 1.0 to 35.0	17.0 T cells/million cells Interval 1.0 to 104.0	33.0 T cells/million cells Interval 1.0 to 85.0	9.0 T cells/million cells Interval 1.0 to 91.0	18.0 T cells/million cells Interval 1.0 to 79.0
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines CD8-All Doubles, D30 [N=10;10;38;36;39;37]	31.0 T cells/million cells Interval 1.0 to 46.0	20.5 T cells/million cells Interval 1.0 to 146.0	39.5 T cells/million cells Interval 1.0 to 102.0	14.0 T cells/million cells Interval 1.0 to 77.5	26.0 T cells/million cells Interval 1.0 to 287.0	34.0 T cells/million cells Interval 1.0 to 90.0
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines CD8-All Doubles, D60 [N=10;9;38;36;38;37]	9.5 T cells/million cells Interval 1.0 to 175.0	16.0 T cells/million cells Interval 1.0 to 33.0	1.0 T cells/million cells Interval 1.0 to 71.0	10.0 T cells/million cells Interval 1.0 to 86.5	59.0 T cells/million cells Interval 1.0 to 167.0	16.0 T cells/million cells Interval 1.0 to 107.0
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines CD8-All Doubles, D210 [N=9;7;37;32;35;34]	1.0 T cells/million cells Interval 1.0 to 179.0	1.0 T cells/million cells Interval 1.0 to 28.0	1.0 T cells/million cells Interval 1.0 to 35.0	1.0 T cells/million cells Interval 1.0 to 84.0	54.0 T cells/million cells Interval 2.0 to 124.0	24.5 T cells/million cells Interval 1.0 to 46.0

SECONDARY outcome

Timeframe: At Day 0, 30, 60 and 210

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ. For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-CD40-L, D60 [N=10;9;38;36;38;37]	87.0 T cells/million cells Interval 1.0 to 227.0	1986.0 T cells/million cells Interval 560.0 to 3173.0	5413.5 T cells/million cells Interval 2535.0 to 7235.0	2813.5 T cells/million cells Interval 1740.0 to 4293.5	4384.5 T cells/million cells Interval 2826.0 to 5813.0	4680.0 T cells/million cells Interval 3120.0 to 6547.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-CD40-L, D0 [N=9;9;38;34;40;39]	104.0 T cells/million cells Interval 66.0 to 306.0	227.0 T cells/million cells Interval 186.0 to 840.0	147.0 T cells/million cells Interval 41.0 to 254.0	151.0 T cells/million cells Interval 107.0 to 320.0	210.5 T cells/million cells Interval 73.0 to 388.0	261.0 T cells/million cells Interval 94.0 to 418.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-CD40-L, D30 [N=10;10;38;36;39;37]	188.0 T cells/million cells Interval 40.0 to 307.0	853.0 T cells/million cells Interval 427.0 to 3133.0	1934.0 T cells/million cells Interval 1333.0 to 3600.0	1280.0 T cells/million cells Interval 833.5 to 2219.5	2334.0 T cells/million cells Interval 1387.0 to 3700.0	3213.0 T cells/million cells Interval 1853.0 to 6801.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-CD40-L, D210 [N=9;7;37;32;35;34]	120.0 T cells/million cells Interval 80.0 to 380.0	1374.0 T cells/million cells Interval 920.0 to 2693.0	3727.0 T cells/million cells Interval 2431.0 to 5733.0	2424.5 T cells/million cells Interval 1586.5 to 3744.0	3173.0 T cells/million cells Interval 2333.0 to 5307.0	3540.0 T cells/million cells Interval 2486.0 to 5025.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD40-IL-2, D0 [N=9;9;38;34;40;39]	146.0 T cells/million cells Interval 93.0 to 467.0	333.0 T cells/million cells Interval 207.0 to 787.0	173.0 T cells/million cells Interval 66.0 to 373.0	224.0 T cells/million cells Interval 80.0 to 477.0	202.5 T cells/million cells Interval 73.5 to 413.0	226.0 T cells/million cells Interval 67.0 to 360.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IL-2, D30 [N=10;10;38;36;39;37]	218.5 T cells/million cells Interval 40.0 to 320.0	1046.5 T cells/million cells Interval 453.0 to 2356.0	2560.0 T cells/million cells Interval 1426.0 to 4680.0	1460.0 T cells/million cells Interval 827.0 to 3093.5	2520.0 T cells/million cells Interval 1147.0 to 4186.0	3120.0 T cells/million cells Interval 1806.0 to 6546.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD40-TNF-α, D0 [N=9;9;38;34;40;39]	78.0 T cells/million cells Interval 53.0 to 334.0	220.0 T cells/million cells Interval 146.0 to 640.0	143.5 T cells/million cells Interval 67.0 to 493.0	180.5 T cells/million cells Interval 79.0 to 449.0	177.5 T cells/million cells Interval 56.0 to 398.0	160.0 T cells/million cells Interval 29.0 to 293.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IL-2, D60 [N=10;9;38;36;38;37]	107.0 T cells/million cells Interval 34.0 to 200.0	1773.0 T cells/million cells Interval 533.0 to 2840.0	5704.0 T cells/million cells Interval 3284.0 to 7947.0	3068.5 T cells/million cells Interval 2055.5 to 4473.0	4460.0 T cells/million cells Interval 2762.0 to 5591.0	4414.0 T cells/million cells Interval 2894.0 to 7027.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IL-2, D210 [N=9;7;37;32;35;34]	114.0 T cells/million cells Interval 66.0 to 312.0	1427.0 T cells/million cells Interval 840.0 to 2227.0	3240.0 T cells/million cells Interval 2360.0 to 5813.0	2180.0 T cells/million cells Interval 1526.5 to 3569.5	3080.0 T cells/million cells Interval 2293.0 to 5226.0	3533.5 T cells/million cells Interval 2400.0 to 5037.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-TNF-α, D30 [N=10;10;38;36;39;37]	185.5 T cells/million cells Interval 93.0 to 346.0	733.5 T cells/million cells Interval 345.0 to 2360.0	2028.0 T cells/million cells Interval 1013.0 to 4080.0	1140.0 T cells/million cells Interval 473.5 to 3026.5	1534.0 T cells/million cells Interval 867.0 to 3813.0	2133.0 T cells/million cells Interval 867.0 to 4480.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-TNF-α, D60 [N=10;9;38;36;38;37]	73.0 T cells/million cells Interval 1.0 to 226.0	907.0 T cells/million cells Interval 427.0 to 1373.0	3993.5 T cells/million cells Interval 1788.0 to 7223.0	2086.5 T cells/million cells Interval 1306.5 to 3754.0	3019.5 T cells/million cells Interval 1790.0 to 3776.0	2867.0 T cells/million cells Interval 1510.0 to 4200.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-TNF-α, D210 [N=9;7;37;32;35;34]	72.0 T cells/million cells Interval 1.0 to 379.0	1106.0 T cells/million cells Interval 718.0 to 2307.0	2960.0 T cells/million cells Interval 1613.0 to 4987.0	1831.0 T cells/million cells Interval 1086.0 to 3096.0	2305.0 T cells/million cells Interval 1694.0 to 4133.0	2580.0 T cells/million cells Interval 1840.0 to 4240.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD40-IFN-γ, D0 [N=9;9;38;34;40;39]	134.0 T cells/million cells Interval 13.0 to 480.0	258.0 T cells/million cells Interval 214.0 to 840.0	180.5 T cells/million cells Interval 67.0 to 471.0	193.5 T cells/million cells Interval 69.0 to 435.0	233.5 T cells/million cells Interval 67.0 to 493.5	306.0 T cells/million cells Interval 146.0 to 483.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IFN-γ, D30 [N=10;10;38;36;39;37]	206.5 T cells/million cells Interval 54.0 to 279.0	626.5 T cells/million cells Interval 333.0 to 2306.0	1477.0 T cells/million cells Interval 496.0 to 3675.0	938.5 T cells/million cells Interval 347.5 to 2500.0	1097.0 T cells/million cells Interval 654.0 to 3440.0	1733.0 T cells/million cells Interval 698.0 to 4688.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IFN-γ, D60 [N=10;9;38;36;38;37]	111.0 T cells/million cells Interval 40.0 to 266.0	1014.0 T cells/million cells Interval 320.0 to 1480.0	3070.5 T cells/million cells Interval 1134.0 to 4794.0	1233.0 T cells/million cells Interval 667.0 to 2946.5	2016.0 T cells/million cells Interval 1253.0 to 3010.0	2453.0 T cells/million cells Interval 1320.0 to 3853.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IFN-γ, D210 [N=9;7;37;32;35;34]	146.0 T cells/million cells Interval 107.0 to 360.0	933.0 T cells/million cells Interval 336.0 to 1826.0	1907.0 T cells/million cells Interval 827.0 to 3413.0	927.0 T cells/million cells Interval 483.5 to 1823.5	1413.0 T cells/million cells Interval 915.0 to 2054.0	1711.0 T cells/million cells Interval 892.0 to 2310.0

SECONDARY outcome

Timeframe: At Day 0, 30, 60 and 210

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 Participants Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Anti-M72 Specific Antibody Concentrations Anti-M72, D30 [N=10;10;39;38;40;39]	1.4 EL.U/mL Interval 1.4 to 1.4	2.9 EL.U/mL Interval 1.4 to 6.0	4.9 EL.U/mL Interval 3.5 to 6.9	5.5 EL.U/mL Interval 4.1 to 7.4	8.7 EL.U/mL Interval 6.5 to 11.7	15.0 EL.U/mL Interval 11.2 to 20.0
Anti-M72 Specific Antibody Concentrations Anti-M72, D0 [N=10;10;39;38;40;39]	1.4 EL.U/mL Interval 1.4 to 1.4	1.4 EL.U/mL Interval 1.4 to 1.4	1.4 EL.U/mL Interval 1.4 to 1.4	1.4 EL.U/mL Interval 1.4 to 1.4	1.4 EL.U/mL Interval 1.4 to 1.4	1.4 EL.U/mL Interval 1.4 to 1.4
Anti-M72 Specific Antibody Concentrations Anti-M72, D60 [N=10;10;39;38;40;39]	1.4 EL.U/mL Interval 1.4 to 1.4	31.0 EL.U/mL Interval 7.3 to 132.0	458.4 EL.U/mL Interval 365.2 to 575.4	468.5 EL.U/mL Interval 367.0 to 598.0	598.6 EL.U/mL Interval 504.0 to 710.9	833.0 EL.U/mL Interval 696.2 to 996.7
Anti-M72 Specific Antibody Concentrations Anti-M72, D210 [N=9;10;38;36;39;36]	1.4 EL.U/mL Interval 1.4 to 1.4	6.1 EL.U/mL Interval 2.1 to 17.8	51.1 EL.U/mL Interval 37.5 to 69.8	46.3 EL.U/mL Interval 37.2 to 57.6	70.7 EL.U/mL Interval 57.5 to 87.0	85.2 EL.U/mL Interval 71.3 to 101.9

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

GSK692342_F1 Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

GSK692342_F2 Group

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

GSK692342_F3 Group

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

GSK692342_F4D1 Group

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

GSK692342_F4D2 Group

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control Group n=10 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Infections and infestations Dengue fever	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Infections and infestations Pyelonephritis acute	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Infections and infestations Typhoid fever	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Gastrointestinal disorders Food poisoning	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210

Other adverse events

Other adverse events
Measure	Control Group n=10 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F1 Group n=10 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F2 Group n=40 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F3 Group n=40 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D1 Group n=40 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.	GSK692342_F4D2 Group n=40 participants at risk Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	10.0% 4/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	7.5% 3/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	7.5% 3/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	5.0% 2/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	5.0% 2/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	7.5% 3/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Feeling hot	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	10.0% 4/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Musculoskeletal and connective tissue disorders Myalgia	20.0% 2/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	20.0% 2/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Chills	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	7.5% 3/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Malaise	50.0% 5/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	30.0% 3/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	57.5% 23/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	62.5% 25/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	57.5% 23/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	65.0% 26/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	20.0% 2/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	5.0% 2/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	7.5% 3/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Gastrointestinal disorders Toothache	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	7.5% 3/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Injury, poisoning and procedural complications Wound	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	0.00% 0/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Pain	90.0% 9/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	50.0% 5/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	95.0% 38/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	92.5% 37/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	92.5% 37/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	90.0% 36/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Redness	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	20.0% 2/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	17.5% 7/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	15.0% 6/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	15.0% 6/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	15.0% 6/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Swelling	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	25.0% 10/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	25.0% 10/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	30.0% 12/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	30.0% 12/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Fatigue	20.0% 2/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	17.5% 7/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	20.0% 8/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	32.5% 13/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	25.0% 10/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Gastro-intestinal symptoms	30.0% 3/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	30.0% 3/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	20.0% 8/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	22.5% 9/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	27.5% 11/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	25.0% 10/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Headache	50.0% 5/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	60.0% 6/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	62.5% 25/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	67.5% 27/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	75.0% 30/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	65.0% 26/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Myalgia	30.0% 3/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	30.0% 3/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	62.5% 25/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	57.5% 23/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	60.0% 24/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	72.5% 29/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Temperature (Axillary)	50.0% 5/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	42.5% 17/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	22.5% 9/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	42.5% 17/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	70.0% 28/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Infections and infestations Nasopharyngitis	40.0% 4/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	50.0% 5/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	37.5% 15/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	25.0% 10/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	45.0% 18/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	40.0% 16/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	40.0% 4/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	7.5% 3/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	15.0% 6/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	32.5% 13/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	27.5% 11/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Nervous system disorders Headache	20.0% 2/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	30.0% 3/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	12.5% 5/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	17.5% 7/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	27.5% 11/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	17.5% 7/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
General disorders Pyrexia	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	30.0% 3/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	10.0% 4/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	10.0% 4/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	12.5% 5/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	7.5% 3/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Nervous system disorders Dizziness	20.0% 2/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	10.0% 1/10 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	2.5% 1/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	12.5% 5/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	10.0% 4/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210	5.0% 2/40 • Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210

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