Trial Outcomes & Findings for Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults. (NCT NCT00707967)

NCT ID: NCT00707967

Last Updated: 2018-08-24

Results Overview

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: During the 7-day period (Days 0-6) post vaccination following each dose
• Results posted on: 2018-08-24

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	GSK692342 Group Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Overall Study STARTED	22	8	7
Overall Study COMPLETED	22	8	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.

Baseline characteristics by cohort

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Total n=37 Participants Total of all reporting groups
Age, Continuous	39.6 Years STANDARD_DEVIATION 7.43 • n=5 Participants	40.0 Years STANDARD_DEVIATION 5.61 • n=7 Participants	41.9 Years STANDARD_DEVIATION 4.67 • n=5 Participants	40.12 Years STANDARD_DEVIATION 6.54 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	26 Participants n=4 Participants

PRIMARY outcome

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

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

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 1	20 Subjects	6 Subjects	1 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 1	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 1	9 Subjects	2 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 1	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 1	8 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 1	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 2	20 Subjects	7 Subjects	2 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 2	3 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 2	8 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 2	7 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Across	21 Subjects	8 Subjects	3 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Across	4 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Across	13 Subjects	2 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Across	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Across	10 Subjects	2 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Across	2 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

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

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

Assessed solicited general symptoms were 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 ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Solicited General Symptoms Any Headache, Dose 1	7 Subjects	4 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue, Dose 1	10 Subjects	6 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Dose 1	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Gastro, Dose 1	4 Subjects	2 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastro, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Gastro, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Headache, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Malaise, Dose 1	3 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Malaise, Dose 1	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Malaise, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia, Dose 1	3 Subjects	2 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature, Dose 1	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Temperature, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue, Dose 2	18 Subjects	3 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Dose 2	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Gastro, Dose 2	4 Subjects	2 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastro, Dose 2	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Gastro, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Headache, Dose 2	11 Subjects	3 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Dose 2	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Headache, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Malaise, Dose 2	3 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Malaise, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Malaise, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia, Dose 2	6 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Dose 2	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature, Dose 2	5 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Temperature, Dose 2	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue, Across	18 Subjects	6 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Across	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue, Across	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Gastro, Across	7 Subjects	3 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastro, Across	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Gastro, Across	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Headache, Across	13 Subjects	4 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Across	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Headache, Across	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Malaise, Across	6 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Malaise, Across	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Malaise, Across	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia, Across	7 Subjects	2 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Across	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia, Across	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature, Across	5 Subjects	2 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature, Across	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Temperature, Across	0 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

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

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

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

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Unsolicited Adverse Events (AEs) Any AEs	21 Subjects	6 Subjects	5 Subjects
Number of Subjects With Unsolicited Adverse Events (AEs) Grade 3 AEs	11 Subjects	2 Subjects	0 Subjects
Number of Subjects With Unsolicited Adverse Events (AEs) Related AEs	4 Subjects	0 Subjects	0 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.

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

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Serious Adverse Events (SAEs)	2 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 0, 7, 30, 37 and 60

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

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 7-normal	11 Subjects	6 Subjects	4 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 30-normal	11 Subjects	4 Subjects	5 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 37-normal	12 Subjects	5 Subjects	5 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 60-normal	13 Subjects	6 Subjects	6 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels BAS, Day 0-normal	19 Subjects	8 Subjects	5 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 0-normal	17 Subjects	5 Subjects	7 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 7-normal	16 Subjects	4 Subjects	7 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 30-normal	16 Subjects	5 Subjects	7 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 37-normal	16 Subjects	6 Subjects	6 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels BAS, Day 7-normal	20 Subjects	8 Subjects	6 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 60-normal	15 Subjects	7 Subjects	7 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 0-normal	13 Subjects	6 Subjects	7 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels BAS, Day 30-normal	18 Subjects	8 Subjects	5 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels BAS, Day 37-normal	12 Subjects	8 Subjects	7 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels BAS, Day 60-normal	18 Subjects	7 Subjects	5 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 0-normal	21 Subjects	7 Subjects	6 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 7-normal	20 Subjects	8 Subjects	7 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 30-normal	20 Subjects	7 Subjects	6 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 37-normal	19 Subjects	7 Subjects	6 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 60-normal	21 Subjects	7 Subjects	6 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels EOS, Day 0-normal	16 Subjects	7 Subjects	6 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels EOS, Day 7-normal	18 Subjects	7 Subjects	7 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels EOS, Day 30-normal	20 Subjects	7 Subjects	4 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels EOS, Day 37-normal	17 Subjects	7 Subjects	5 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels EOS, Day 60-normal	16 Subjects	6 Subjects	7 Subjects

PRIMARY outcome

Timeframe: At Day 0, 7, 30, 37 and 60

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

Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Normal Haematological Levels Hgb, Day 37-normal	18 Subjects	7 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels Hgb, Day 60-normal	17 Subjects	8 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels LYM, Day 0-normal	12 Subjects	6 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels LYM, Day 7-normal	16 Subjects	6 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels LYM, Day 30-normal	12 Subjects	6 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels LYM, Day 37-normal	18 Subjects	6 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels LYM, Day 60-normal	16 Subjects	6 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels MON, Day 0-normal	21 Subjects	8 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels MON, Day 7-normal	21 Subjects	8 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels MON, Day 30-normal	21 Subjects	8 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels MON, Day 37-normal	21 Subjects	8 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels MON, Day 60-normal	22 Subjects	7 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels NEU, Day 0-normal	14 Subjects	7 Subjects	5 Subjects
Number of Subjects With Normal Haematological Levels NEU, Day 7-normal	21 Subjects	7 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels NEU, Day 30-normal	17 Subjects	7 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels NEU, Day 37-normal	16 Subjects	7 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels NEU, Day 60-normal	16 Subjects	7 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels Hct, Day 0-normal	18 Subjects	6 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels Hct, Day 7-normal	18 Subjects	6 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels Hct, Day 30-normal	20 Subjects	8 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels Hct, Day 37-normal	16 Subjects	6 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels Hct, Day 60-normal	18 Subjects	8 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels Hgb, Day 0-normal	19 Subjects	8 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels Hgb, Day 7-normal	15 Subjects	7 Subjects	7 Subjects
Number of Subjects With Normal Haematological Levels Hgb, Day 30-normal	18 Subjects	8 Subjects	7 Subjects

PRIMARY outcome

Timeframe: At Day 0, 7, 30, 37 and 60

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

Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Normal Haematological Levels PLA, Day 0-normal	21 Subjects	7 Subjects	5 Subjects
Number of Subjects With Normal Haematological Levels PLA, Day 7-normal	21 Subjects	8 Subjects	5 Subjects
Number of Subjects With Normal Haematological Levels PLA, Day 30-normal	21 Subjects	6 Subjects	4 Subjects
Number of Subjects With Normal Haematological Levels PLA, Day 37-normal	21 Subjects	7 Subjects	5 Subjects
Number of Subjects With Normal Haematological Levels PLA, Day 60-normal	20 Subjects	7 Subjects	4 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 0-normal	13 Subjects	5 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 7-normal	13 Subjects	5 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 30-normal	13 Subjects	6 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 37-normal	12 Subjects	6 Subjects	5 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 60-normal	13 Subjects	7 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 0-normal	16 Subjects	7 Subjects	5 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 7-normal	18 Subjects	7 Subjects	5 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 30-normal	16 Subjects	6 Subjects	6 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 37-normal	17 Subjects	6 Subjects	5 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 60-normal	16 Subjects	6 Subjects	5 Subjects

PRIMARY outcome

Timeframe: At Day 0, 7, 30, 37 and 60

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

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Biochemical and Haematological Levels Below Normal ALT, Day 30-below	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal ALT, Day 37-below	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal ALT, Day 60-below	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal AST, Day 0-below	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal AST, Day 7-below	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal AST, Day 30-below	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal AST, Day 37-below	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal AST, Day 60-below	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal BAS, Day 0-below	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal BAS, Day 7-below	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal BAS, Day 30-below	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal BAS, Day 37-below	5 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal BAS, Day 60-below	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal CREA, Day 0-below	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal ALT, Day 0-below	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal ALT, Day 7-below	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal CREA, Day 7-below	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal CREA, Day 30-below	1 Subjects	1 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal CREA, Day 37-below	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal CREA, Day 60-below	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal EOS, Day 0-below	4 Subjects	1 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal EOS, Day 7-below	3 Subjects	1 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal EOS, Day 30-below	0 Subjects	1 Subjects	3 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal EOS, Day 37-below	4 Subjects	1 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Below Normal EOS, Day 60-below	4 Subjects	1 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 0, 7, 30, 37 and 60

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

Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Haematological Levels Below Normal Hct, Day 0-below	4 Subjects	2 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal Hct, Day 7-below	4 Subjects	2 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal Hct, Day 30-below	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal Hct, Day 37-below	6 Subjects	2 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal Hct, Day 60-below	4 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal Hgb, Day 0-below	3 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal Hgb, Day 7-below	7 Subjects	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal Hgb, Day 30-below	4 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal Hgb, Day 37-below	4 Subjects	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal Hgb, Day 60-below	5 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal LYM, Day 0-below	10 Subjects	2 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal LYM, Day 7-below	6 Subjects	2 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal LYM, Day 30-below	10 Subjects	2 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal LYM, Day 37-below	4 Subjects	2 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal LYM, Day 60-below	6 Subjects	2 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal MON, Day 0-below	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal MON, Day 7-below	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal MON, Day 30-below	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal MON, Day 37-below	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal MON, Day 60-below	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal NEU, Day 0-below	7 Subjects	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal NEU, Day 7-below	1 Subjects	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal NEU, Day 30-below	5 Subjects	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal NEU, Day 37-below	5 Subjects	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal NEU, Day 60-below	5 Subjects	1 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 0, 7, 30, 37 and 60

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

Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Haematological Levels Below Normal PLA, Day 0-below	1 Subjects	1 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal PLA, Day 7-below	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal PLA, Day 30-below	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Haematological Levels Below Normal PLA, Day 37-below	1 Subjects	1 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal PLA, Day 60-below	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Haematological Levels Below Normal RBC, Day 0-below	9 Subjects	3 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal RBC, Day 7-below	9 Subjects	3 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal RBC, Day 30-below	9 Subjects	2 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal RBC, Day 37-below	10 Subjects	2 Subjects	2 Subjects
Number of Subjects With Haematological Levels Below Normal RBC, Day 60-below	9 Subjects	1 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 0-below	5 Subjects	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 7-below	4 Subjects	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 30-below	6 Subjects	2 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 37-below	4 Subjects	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 60-below	5 Subjects	2 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 0, 7, 30, 37 and 60

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

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Biochemical and Haematological Levels Above Normal ALT, Day 0-above	4 Subjects	3 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal ALT, Day 7-above	6 Subjects	4 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal ALT, Day 30-above	5 Subjects	3 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal ALT, Day 37-above	5 Subjects	2 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal ALT, Day 60-above	6 Subjects	1 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal AST, Day 0-above	9 Subjects	2 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal AST, Day 7-above	11 Subjects	2 Subjects	3 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal AST, Day 30-above	11 Subjects	4 Subjects	2 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal AST, Day 37-above	10 Subjects	3 Subjects	2 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal AST, Day 60-above	9 Subjects	2 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal BAS, Day 0-above	2 Subjects	0 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal BAS, Day 7-above	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal BAS, Day 30-above	2 Subjects	0 Subjects	2 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal BAS, Day 37-above	5 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal BAS, Day 60-above	3 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal CREA, Day 0-above	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal CREA, Day 7-above	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal CREA, Day 30-above	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal CREA, Day 37-above	3 Subjects	0 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal CREA, Day 60-above	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal EOS, Day 0-above	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal EOS, Day 7-above	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal EOS, Day 30-above	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal EOS, Day 37-above	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Levels Above Normal EOS, Day 60-above	2 Subjects	1 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 0, 7, 30, 37 and 60

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

Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Haematological Levels Above Normal Hct, Day 0-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal Hct, Day 7-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal Hct, Day 30-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal Hct, Day 37-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal Hct, Day 60-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal Hgb, Day 0-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal Hgb, Day 7-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal Hgb, Day 30-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal Hgb, Day 37-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal Hgb, Day 60-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal LYM, Day 0-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal LYM, Day 7-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal LYM, Day 30-above	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal LYM, Day 37-above	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal LYM, Day 60-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal MON, Day 0-above	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal MON, Day 7-above	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal MON, Day 30-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal MON, Day 37-above	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal MON, Day 60-above	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal NEU, Day 0-above	1 Subjects	0 Subjects	2 Subjects
Number of Subjects With Haematological Levels Above Normal NEU, Day 7-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal NEU, Day 30-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal NEU, Day 37-above	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal NEU, Day 60-above	1 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 0, 7, 30, 37 and 60

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

Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Haematological Levels Above Normal PLA, Day 0-above	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal PLA, Day 7-above	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal PLA, Day 30-above	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal PLA, Day 37-above	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal PLA, Day 60-above	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 0-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 7-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 30-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 37-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 60-above	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 0-above	1 Subjects	0 Subjects	2 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 7-above	0 Subjects	0 Subjects	2 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 30-above	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 37-above	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 60-above	1 Subjects	0 Subjects	2 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

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
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, Day 0 [N=22;8;7]	95.0 T cells/million cells Interval 1.0 to 218.0	154.5 T cells/million cells Interval 40.5 to 160.5	96.0 T cells/million cells Interval 1.0 to 267.0
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, Day 30 [N=22;8;7]	1713.5 T cells/million cells Interval 507.0 to 2786.0	129.0 T cells/million cells Interval 103.5 to 204.5	94.0 T cells/million cells Interval 1.0 to 226.0
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, Day 60 [N=22;8;7]	7003.5 T cells/million cells Interval 3691.0 to 10701.0	112.0 T cells/million cells Interval 51.0 to 258.0	26.0 T cells/million cells Interval 13.0 to 227.0
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, Day 210 [N=21;8;7]	4245.0 T cells/million cells Interval 2427.0 to 6121.0	83.5 T cells/million cells Interval 16.0 to 140.0	67.0 T cells/million cells Interval 4.0 to 133.0
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, Day 0 [N=22;8;7]	167.0 T cells/million cells Interval 1.0 to 358.0	71.5 T cells/million cells Interval 11.0 to 442.0	364.0 T cells/million cells Interval 80.0 to 1001.0
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, Day 30 [N=22;8;7]	97.0 T cells/million cells Interval 27.0 to 507.0	38.5 T cells/million cells Interval 8.0 to 293.0	216.0 T cells/million cells Interval 1.0 to 986.0
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, Day 60 [N=22;8;7]	236.0 T cells/million cells Interval 19.0 to 542.0	74.5 T cells/million cells Interval 1.0 to 570.0	415.0 T cells/million cells Interval 25.0 to 889.0
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, Day 210 [N=21;8;7]	195.0 T cells/million cells Interval 20.0 to 340.0	55.5 T cells/million cells Interval 1.0 to 248.5	241.0 T cells/million cells Interval 39.0 to 858.0

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 interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [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

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IFN-γ, Day 210 [N=21;8;7]	667.0 T cells/million cells Interval 227.0 to 2026.0	51.5 T cells/million cells Interval 1.0 to 87.0	40.0 T cells/million cells Interval 1.0 to 119.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-CD40-L, Day 0 [N=22;8;7]	88.5 T cells/million cells Interval 26.0 to 185.0	135.0 T cells/million cells Interval 54.0 to 152.0	110.0 T cells/million cells Interval 1.0 to 240.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-CD40-L, Day 30 [N=22;8;7]	1389.5 T cells/million cells Interval 506.0 to 2359.0	129.0 T cells/million cells Interval 71.5 to 196.5	94.0 T cells/million cells Interval 1.0 to 226.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-CD40-L, Day 60 [N=22;8;7]	6771.5 T cells/million cells Interval 3334.0 to 10235.0	112.0 T cells/million cells Interval 54.5 to 211.5	40.0 T cells/million cells Interval 26.0 to 213.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-CD40-L, Day 210 [N=21;8;7]	3953.0 T cells/million cells Interval 1477.0 to 4853.0	71.0 T cells/million cells Interval 1.0 to 145.0	53.0 T cells/million cells Interval 1.0 to 120.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IL-2, Day 0 [N=22;8;7]	104.0 T cells/million cells Interval 40.0 to 160.0	87.0 T cells/million cells Interval 52.5 to 118.0	120.0 T cells/million cells Interval 13.0 to 267.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IL-2, Day 30 [N=22;8;7]	1140.0 T cells/million cells Interval 427.0 to 2141.0	136.5 T cells/million cells Interval 58.0 to 200.0	93.0 T cells/million cells Interval 12.0 to 173.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IL-2, Day 60 [N=22;9;7]	6640.5 T cells/million cells Interval 3213.0 to 9520.0	80.0 T cells/million cells Interval 22.0 to 253.5	27.0 T cells/million cells Interval 1.0 to 174.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IL-2, Day 210 [N=21;8;7]	4166.0 T cells/million cells Interval 1477.0 to 5347.0	74.0 T cells/million cells Interval 1.0 to 127.0	67.0 T cells/million cells Interval 1.0 to 120.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD40-TNF-α, Day 0 [N=22;8;7]	40.0 T cells/million cells Interval 1.0 to 120.0	106.5 T cells/million cells Interval 63.5 to 154.5	63.0 T cells/million cells Interval 1.0 to 240.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-TNF-α, Day 30 [N=22;8;7]	793.5 T cells/million cells Interval 226.0 to 2093.0	27.5 T cells/million cells Interval 20.0 to 65.0	107.0 T cells/million cells Interval 13.0 to 147.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-TNF-α, Day 60 [N=22;8;7]	4286.5 T cells/million cells Interval 2294.0 to 6880.0	38.5 T cells/million cells Interval 11.5 to 78.5	80.0 T cells/million cells Interval 13.0 to 226.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-TNF-α, Day 210 [N=21;8;7]	2632.0 T cells/million cells Interval 1560.0 to 4186.0	54.0 T cells/million cells Interval 17.5 to 81.0	54.0 T cells/million cells Interval 13.0 to 107.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD40-IFN-γ, Day 0 [N=22;8;7]	64.0 T cells/million cells Interval 26.0 to 212.0	29.5 T cells/million cells Interval 19.0 to 113.5	67.0 T cells/million cells Interval 26.0 to 147.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IFN-γ, Day 30 [N=22;8;7]	413.5 T cells/million cells Interval 119.0 to 1373.0	99.0 T cells/million cells Interval 82.5 to 147.5	106.0 T cells/million cells Interval 26.0 to 199.0
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule CD4-IFN-γ, Day 60 [N=22;8;7]	1733.5 T cells/million cells Interval 440.0 to 3455.0	102.5 T cells/million cells Interval 53.0 to 221.0	26.0 T cells/million cells Interval 13.0 to 79.0

SECONDARY outcome

Timeframe: At Day 0, 30, 60 and 210

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

CD4+ T cell counts are defined by values greater than (>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Cell Count of CD4+ T Cells CD4+ T Cells, Day 0	585 T cells/cubic millimeter Interval 416.0 to 651.0	437 T cells/cubic millimeter Interval 318.5 to 561.0	811 T cells/cubic millimeter Interval 704.0 to 1050.0
Cell Count of CD4+ T Cells CD4+ T Cells, Day 30	566 T cells/cubic millimeter Interval 465.0 to 713.0	410.5 T cells/cubic millimeter Interval 283.5 to 527.5	799 T cells/cubic millimeter Interval 750.0 to 978.0
Cell Count of CD4+ T Cells CD4+ T Cells, Day 60	567 T cells/cubic millimeter Interval 457.0 to 679.0	368 T cells/cubic millimeter Interval 339.0 to 572.5	877 T cells/cubic millimeter Interval 745.0 to 1062.0
Cell Count of CD4+ T Cells CD 4+ T Cells, Day 210	548.5 T cells/cubic millimeter Interval 426.0 to 680.0	433 T cells/cubic millimeter Interval 377.0 to 534.0	822 T cells/cubic millimeter Interval 741.0 to 1138.0

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 in Geometric Mean Concentrations (GMCs).

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Anti-M72 Specific Antibody Concentrations Anti-M72, Day 30 [N=22;8;7]	2.1 EL.U/mL Interval 1.5 to 2.9	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, Day 60 [N=22;8;7]	282.4 EL.U/mL Interval 177.2 to 450.0	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, Day 210 [N=21;8;7]	38.3 EL.U/mL Interval 22.8 to 64.2	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, Day 0 [N=22;8;7]	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

SECONDARY outcome

Timeframe: From Day 60 to Day 210

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

Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.

Outcome measures

Measure	GSK692342 Group n=22 Participants Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 Participants Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 Participants Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes	0 Subjects	1 Subjects	0 Subjects

Adverse Events

GSK692342 Group

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK692342 Group n=22 participants at risk Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 participants at risk Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 participants at risk Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Infections and infestations Appendicitis	4.5% 1/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Infections and infestations Cellulitis	4.5% 1/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.

Other adverse events

Measure	GSK692342 Group n=22 participants at risk Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Control Group n=8 participants at risk Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.	Placebo Group n=7 participants at risk Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
Infections and infestations Nasopharyngitis	18.2% 4/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	25.0% 2/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	28.6% 2/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Nervous system disorders Headache	22.7% 5/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	25.0% 2/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Investigations Cd4 lymphocytes decreased	22.7% 5/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Musculoskeletal and connective tissue disorders Myalgia	18.2% 4/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Nervous system disorders Migraine	13.6% 3/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Musculoskeletal and connective tissue disorders Back pain	9.1% 2/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	12.5% 1/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 1/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	28.6% 2/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Fatigue	81.8% 18/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	75.0% 6/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	42.9% 3/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Feeling hot	9.1% 2/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Injection site pruritus	9.1% 2/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.1% 2/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 2/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Pyrexia	9.1% 2/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Eye disorders Pterygium	0.00% 0/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Gastrointestinal disorders Abdominal pain upper	4.5% 1/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Gastrointestinal disorders Diarrhoea	4.5% 1/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	12.5% 1/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Gastrointestinal disorders Flatulence	0.00% 0/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	12.5% 1/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Gastrointestinal disorders Vomiting	4.5% 1/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	12.5% 1/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Infections and infestations Genital herpes	0.00% 0/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	12.5% 1/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Infections and infestations Oral herpes	4.5% 1/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Infections and infestations Subcutaneous abscess	0.00% 0/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Psychiatric disorders Insomnia	4.5% 1/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Reproductive system and breast disorders Dysmenorrhoea	4.5% 1/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	12.5% 1/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	12.5% 1/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Pain	95.5% 21/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	100.0% 8/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	42.9% 3/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Redness	59.1% 13/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	25.0% 2/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Swelling	45.5% 10/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	25.0% 2/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	0.00% 0/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Gastrointestinal	31.8% 7/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	37.5% 3/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Headache	59.1% 13/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	50.0% 4/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	42.9% 3/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Malaise	27.3% 6/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	12.5% 1/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Myalgia	31.8% 7/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	25.0% 2/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
General disorders Temperature (Axillary)	22.7% 5/22 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	25.0% 2/8 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.	14.3% 1/7 • Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 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