Trial Outcomes & Findings for Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents (NCT NCT00950612)

Last Updated: 2018-08-17

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

60 participants

Primary outcome timeframe

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

Results posted on

2018-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	GSK692342 Group Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Overall Study STARTED	40	20
Overall Study COMPLETED	40	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.	Total n=60 Participants Total of all reporting groups
Age, Continuous	14.8 Years STANDARD_DEVIATION 1.20 • n=113 Participants	14.9 Years STANDARD_DEVIATION 1.12 • n=163 Participants	14.83 Years STANDARD_DEVIATION 1.17 • n=160 Participants
Sex: Female, Male Female	18 Participants n=113 Participants	11 Participants n=163 Participants	29 Participants n=160 Participants
Sex: Female, Male Male	22 Participants n=113 Participants	9 Participants n=163 Participants	31 Participants n=160 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 for whom data were available.

Outcome measures

Outcome measures
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 1 [N=40;18]	37 Subjects	3 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 1 [N=40;18]	3 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 1 [N=40;18]	7 Subjects	2 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 1 [N=40;18]	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 1 [N=40;18]	14 Subjects	2 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 1 [N=40;18]	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 2 [N=40;20]	35 Subjects	5 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 2 [N=40;20]	7 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 2 [N=40;20]	10 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 2 [N=40;20]	1 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 2 [N=40;20]	13 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 2 [N=40;20]	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Across [N=40;20]	38 Subjects	7 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Across [N=40;20]	8 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Across [N=40;20]	13 Subjects	2 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Across [N=40;20]	1 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Across [N=40;20]	20 Subjects	2 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Across [N=40;20]	0 Subjects	0 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 for whom data were available.

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

Outcome measures
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Solicited General Symptoms Related Temperature, Across [N=40;20]	24 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature, Dose 1 [N=40;18]	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Malaise, Dose 2 [N=40;20]	13 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Related Malaise, Dose 2 [N=40;20]	13 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Malaise, Dose 2 [N=40;20]	3 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia, Dose 2 [N=40;20]	5 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue, Dose 2 [N=40;20]	20 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue, Dose 2 [N=40;20]	20 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature, Across [N=40;20]	24 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature, Across [N=40;20]	3 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Dose 2 [N=40;20]	3 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Gastro, Dose 2 [N=40;20]	13 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Related Gastro, Dose 2 [N=40;20]	13 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastro, Dose 2 [N=40;20]	0 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Any Headache, Dose 2 [N=40;20]	27 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Related Headache, Dose 2 [N=40;20]	27 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Dose 2 [N=40;20]	6 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue, Dose 1 [N=40;18]	11 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue, Dose 1 [N=40;18]	11 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Dose 1 [N=40;18]	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Gastro, Dose 1 [N=40;18]	9 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Related Gastro, Dose 1 [N=40;18]	9 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastro, Dose 1 [N=40;18]	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Headache, Dose 1 [N=40;18]	16 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Related Headache, Dose 1 [N=40;18]	15 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Dose 1 [N=40;18]	3 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Malaise, Dose 1 [N=40;18]	6 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Malaise, Dose 1 [N=40;18]	6 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Malaise, Dose 1 [N=40;18]	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia, Dose 1 [N=40;18]	4 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia, Dose 1 [N=40;18]	4 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Dose 1 [N=40;18]	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature, Dose 1 [N=40;18]	12 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Temperature, Dose 1 [N=40;18]	11 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia, Dose 2 [N=40;20]	5 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Dose 2 [N=40;20]	2 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature, Dose 2 [N=40;20]	24 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Related Temperature, Dose 2 [N=40;20]	24 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature, Dose 2 [N=40;20]	3 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue, Across [N=40;20]	21 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue, Across [N=40;20]	21 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Across [N=40;20]	3 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Gastro, Across [N=40;20]	18 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms Related Gastro, Across [N=40;20]	18 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastro, Across [N=40;20]	1 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Any Headache, Across [N=40;20]	28 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms Related Headache, Across [N=40;20]	28 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Across [N=40;20]	7 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Malaise, Across [N=40;20]	14 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Related Malaise, Across [N=40;20]	14 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Malaise, Across [N=40;20]	3 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia, Across [N=40;20]	7 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia, Across [N=40;20]	7 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Across [N=40;20]	2 Subjects	0 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 for 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 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

Outcome measures
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Unsolicited Adverse Events (AEs)	9 Subjects	3 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 for 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	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Serious Adverse Events (SAEs)	0 Subjects	0 Subjects

PRIMARY outcome

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

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

Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine \[CREA\], haemoglobin \[Hgb\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.

Outcome measures

Outcome measures
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 0-normal	37 Subjects	20 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 7-normal	40 Subjects	20 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 30-normal	40 Subjects	19 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 37-normal	38 Subjects	20 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels ALT, Day 60-normal	40 Subjects	20 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 0-normal	36 Subjects	17 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 7-normal	40 Subjects	20 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 30-normal	38 Subjects	20 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 37-normal	39 Subjects	20 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels AST, Day 60-normal	38 Subjects	20 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 0-normal	23 Subjects	10 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 7-normal	20 Subjects	5 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 30-normal	18 Subjects	7 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 37-normal	17 Subjects	9 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels CREA, Day 60-normal	17 Subjects	8 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels Hgb, Day 0-normal	31 Subjects	17 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels Hgb, Day 7-normal	28 Subjects	16 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels Hgb, Day 30-normal	27 Subjects	16 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels Hgb, Day 37-normal	22 Subjects	16 Subjects
Number of Subjects With Normal Biochemical and Haematological Levels Hgb, Day 60-normal	32 Subjects	16 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 for whom data were available.

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

Outcome measures

Outcome measures
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Normal Haematological Levels PLA, Day 0-normal	40 Subjects	19 Subjects
Number of Subjects With Normal Haematological Levels PLA, Day 7-normal	38 Subjects	19 Subjects
Number of Subjects With Normal Haematological Levels PLA, Day 30-normal	39 Subjects	19 Subjects
Number of Subjects With Normal Haematological Levels PLA, Day 37-normal	38 Subjects	19 Subjects
Number of Subjects With Normal Haematological Levels PLA, Day 60-normal	39 Subjects	20 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 0-normal	29 Subjects	14 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 7-normal	32 Subjects	17 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 30-normal	30 Subjects	16 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 37-normal	28 Subjects	17 Subjects
Number of Subjects With Normal Haematological Levels RBC, Day 60-normal	29 Subjects	15 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 0-normal	36 Subjects	17 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 7-normal	34 Subjects	18 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 30-normal	37 Subjects	18 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 37-normal	38 Subjects	17 Subjects
Number of Subjects With Normal Haematological Levels WBC, Day 60-normal	33 Subjects	18 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 for whom data were available.

Outcome measures

Outcome measures
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Biochemical and Haematological Above Normal Levels ALT, Day 0-above	3 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels ALT, Day 7- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels ALT, Day 30- above	0 Subjects	1 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels ALT, Day 37- above	2 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels ALT, Day 60- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels AST, Day 0- above	1 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels AST, Day 7- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels AST, Day 30- above	1 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels AST, Day 37- above	1 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels AST, Day 60- above	1 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels CREA, Day 0- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels CREA, Day 7- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels CREA, Day 30- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels CREA, Day 37- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels CREA, Day 60- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels Hgb, Day 0- above	1 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels Hgb, Day 7- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels Hgb, Day 30- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels Hgb, Day 37- above	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Above Normal Levels Hgb, Day 60- above	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 for whom data were available.

Outcome measures

Outcome measures
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Haematological Levels Above Normal PLA, Day 0-above	0 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal PLA, Day 7- above	2 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal PLA, Day 30- above	1 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal PLA, Day 37- above	2 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal PLA, Day 60- above	1 Subjects	0 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 0- above	9 Subjects	5 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 7- above	3 Subjects	2 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 30- above	7 Subjects	4 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 37- above	7 Subjects	2 Subjects
Number of Subjects With Haematological Levels Above Normal RBC, Day 60- above	7 Subjects	4 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 0- above	2 Subjects	2 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 7- above	2 Subjects	1 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 30- above	0 Subjects	2 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 37- above	1 Subjects	2 Subjects
Number of Subjects With Haematological Levels Above Normal WBC, Day 60- above	5 Subjects	1 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 for whom data were available.

Outcome measures

Outcome measures
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Biochemical and Haematological Below Normal Levels ALT, Day 0-below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels ALT, Day 7- below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels ALT, Day 30-below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels ALT, Day 37-below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels ALT, Day 60-below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels AST, Day 0-below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels AST, Day 7-below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels AST, Day 30-below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels AST, Day 37- below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels AST, Day 60- below	0 Subjects	0 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels CREA, Day 0- below	17 Subjects	10 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels CREA, Day 7- below	20 Subjects	15 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels CREA, Day 30-below	22 Subjects	13 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels CREA, Day 37-below	23 Subjects	11 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels CREA, Day 60-below	23 Subjects	12 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels Hgb, Day 0- below	8 Subjects	3 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels Hgb, Day 7- below	12 Subjects	4 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels Hgb, Day 30- below	13 Subjects	4 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels Hgb, Day 37- below	18 Subjects	4 Subjects
Number of Subjects With Biochemical and Haematological Below Normal Levels Hgb, Day 60- below	8 Subjects	4 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 for whom data were available.

Outcome measures

Outcome measures
Measure	GSK692342 Group n=40 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Number of Subjects With Haematological Levels Below Normal RBC, Day 37-below	5 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal RBC, Day 60-below	4 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal PLA, Day 0-below	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal PLA, Day 7-below	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal PLA, Day 30-below	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal PLA, Day 37-below	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal PLA, Day 60-below	0 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal RBC, Day 0-below	2 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal RBC, Day 7-below	5 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal RBC, Day 30-below	3 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 0-below	2 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 7-below	4 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 30-below	3 Subjects	0 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 37-below	1 Subjects	1 Subjects
Number of Subjects With Haematological Levels Below Normal WBC, Day 60-below	2 Subjects	1 Subjects

SECONDARY outcome

Timeframe: At Day 0, 7, 30, 37, 60 and 210

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.

Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and 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	GSK692342 Group n=38 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
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=36;17]	75.5 T cells/million cells Interval 1.0 to 173.0	44.0 T cells/million cells Interval 1.0 to 112.0
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 7 [N=32;15]	4618.0 T cells/million cells Interval 554.5 to 17231.0	146.0 T cells/million cells Interval 1.0 to 352.0
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 0 [N=36;17]	200.5 T cells/million cells Interval 53.0 to 400.5	57.0 T cells/million cells Interval 4.0 to 402.0
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=38;18]	2102.0 T cells/million cells Interval 946.0 to 6764.0	122.0 T cells/million cells Interval 48.0 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 37 [N=37;19]	8169.0 T cells/million cells Interval 4643.0 to 13735.0	159.0 T cells/million cells Interval 1.0 to 385.0
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=38;20]	5621.0 T cells/million cells Interval 2958.0 to 8746.0	127.0 T cells/million cells Interval 32.5 to 301.5
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=36;20]	2866.0 T cells/million cells Interval 1480.0 to 3830.0	113.5 T cells/million cells Interval 1.0 to 372.5
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 7 [N=32;15]	1515.0 T cells/million cells Interval 125.0 to 5802.0	1.0 T cells/million cells Interval 1.0 to 128.0
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=38;18]	93.5 T cells/million cells Interval 1.0 to 246.0	15.5 T cells/million cells Interval 1.0 to 114.0
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 37 [N=37;19]	648.0 T cells/million cells Interval 378.0 to 1526.0	37.0 T cells/million cells Interval 1.0 to 116.0
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=38;20]	113.5 T cells/million cells Interval 48.0 to 240.0	76.5 T cells/million cells Interval 18.0 to 111.0
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=36;20]	33.5 T cells/million cells Interval 1.0 to 81.0	31.5 T cells/million cells Interval 1.0 to 80.0

SECONDARY outcome

Timeframe: At Day 0, 7, 30, 37, 60 and 210

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.

Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).

Outcome measures

Outcome measures
Measure	GSK692342 Group n=39 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D0[N=38;19]	42.0 T cells/million cells Interval 1.0 to 136.0	92.0 T cells/million cells Interval 1.0 to 314.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20]	36.0 T cells/million cells Interval 1.0 to 144.0	1.0 T cells/million cells Interval 1.0 to 63.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20]	107.0 T cells/million cells Interval 66.0 to 169.0	1.0 T cells/million cells Interval 1.0 to 24.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20]	66.5 T cells/million cells Interval 21.0 to 109.0	1.0 T cells/million cells Interval 1.0 to 11.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D7[N=36;15]	36.0 T cells/million cells Interval 1.0 to 213.0	1.0 T cells/million cells Interval 1.0 to 247.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D30[N=39;20]	172.0 T cells/million cells Interval 8.0 to 374.0	1.0 T cells/million cells Interval 1.0 to 77.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D37[N=39;20]	593.0 T cells/million cells Interval 382.0 to 944.0	13.5 T cells/million cells Interval 1.0 to 164.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D60[N=38;20]	344.0 T cells/million cells Interval 164.0 to 649.0	10.5 T cells/million cells Interval 1.0 to 124.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D210[N=37;20]	263.0 T cells/million cells Interval 112.0 to 548.0	46.5 T cells/million cells Interval 1.0 to 154.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 100.0	1.0 T cells/million cells Interval 1.0 to 21.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15]	74.5 T cells/million cells Interval 1.0 to 236.5	28.0 T cells/million cells Interval 1.0 to 101.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20]	163.0 T cells/million cells Interval 107.0 to 252.0	1.0 T cells/million cells Interval 1.0 to 24.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20]	506.0 T cells/million cells Interval 306.0 to 825.0	17.0 T cells/million cells Interval 1.0 to 105.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20]	296.0 T cells/million cells Interval 140.0 to 521.0	40.5 T cells/million cells Interval 1.0 to 72.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20]	1.0 T cells/million cells Interval 1.0 to 107.0	1.0 T cells/million cells Interval 1.0 to 93.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 38.0	1.0 T cells/million cells Interval 1.0 to 165.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15]	84.0 T cells/million cells Interval 1.0 to 396.0	20.0 T cells/million cells Interval 1.0 to 111.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20]	1.0 T cells/million cells Interval 1.0 to 173.0	9.0 T cells/million cells Interval 1.0 to 114.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20]	357.0 T cells/million cells Interval 142.0 to 648.0	1.0 T cells/million cells Interval 1.0 to 122.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20]	90.5 T cells/million cells Interval 1.0 to 218.0	1.0 T cells/million cells Interval 1.0 to 80.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20]	1.0 T cells/million cells Interval 1.0 to 57.0	1.0 T cells/million cells Interval 1.0 to 7.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19]	68.5 T cells/million cells Interval 22.0 to 116.0	18.0 T cells/million cells Interval 1.0 to 165.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15]	579.5 T cells/million cells Interval 95.0 to 1757.0	47.0 T cells/million cells Interval 1.0 to 91.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20]	103.0 T cells/million cells Interval 27.0 to 327.0	32.5 T cells/million cells Interval 1.0 to 59.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20]	871.0 T cells/million cells Interval 512.0 to 1624.0	43.0 T cells/million cells Interval 1.0 to 91.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20]	183.5 T cells/million cells Interval 97.0 to 366.0	50.0 T cells/million cells Interval 22.5 to 78.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 28.0	1.0 T cells/million cells Interval 1.0 to 24.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40(+)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15]	95.0 T cells/million cells Interval 43.5 to 210.0	1.0 T cells/million cells Interval 1.0 to 48.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20]	190.0 T cells/million cells Interval 119.0 to 350.0	1.0 T cells/million cells Interval 1.0 to 19.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20]	588.0 T cells/million cells Interval 431.0 to 1003.0	11.0 T cells/million cells Interval 1.0 to 41.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20]	375.0 T cells/million cells Interval 228.0 to 984.0	1.0 T cells/million cells Interval 1.0 to 27.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20]	402.0 T cells/million cells Interval 256.0 to 920.0	1.0 T cells/million cells Interval 1.0 to 87.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 27.0	1.0 T cells/million cells Interval 1.0 to 23.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15]	47.0 T cells/million cells Interval 1.0 to 90.5	1.0 T cells/million cells Interval 1.0 to 31.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20]	23.0 T cells/million cells Interval 1.0 to 62.0	1.0 T cells/million cells Interval 1.0 to 1.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20]	65.5 T cells/million cells Interval 24.0 to 143.0	1.0 T cells/million cells Interval 1.0 to 36.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20]	44.0 T cells/million cells Interval 13.0 to 70.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 21.0	1.0 T cells/million cells Interval 1.0 to 5.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15]	120.0 T cells/million cells Interval 21.0 to 335.0	1.0 T cells/million cells Interval 1.0 to 34.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20]	23.0 T cells/million cells Interval 1.0 to 48.0	1.0 T cells/million cells Interval 1.0 to 35.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20]	169.0 T cells/million cells Interval 92.0 to 447.0	1.0 T cells/million cells Interval 1.0 to 22.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20]	70.0 T cells/million cells Interval 15.0 to 110.0	1.0 T cells/million cells Interval 1.0 to 14.5

SECONDARY outcome

Timeframe: At Day 0, 7, 30, 37, 60 and 210

Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).

Outcome measures

Outcome measures
Measure	GSK692342 Group n=39 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20]	270.0 T cells/million cells Interval 117.0 to 614.0	1.0 T cells/million cells Interval 1.0 to 26.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20]	347.0 T cells/million cells Interval 157.0 to 640.0	21.0 T cells/million cells Interval 1.0 to 96.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20]	197.0 T cells/million cells Interval 121.0 to 340.0	15.5 T cells/million cells Interval 1.0 to 53.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15]	64.5 T cells/million cells Interval 1.0 to 438.5	1.0 T cells/million cells Interval 1.0 to 21.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20]	22.0 T cells/million cells Interval 1.0 to 155.0	1.0 T cells/million cells Interval 1.0 to 23.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20]	97.0 T cells/million cells Interval 31.0 to 836.0	1.0 T cells/million cells Interval 1.0 to 56.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 31.0	1.0 T cells/million cells Interval 1.0 to 13.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15]	59.0 T cells/million cells Interval 1.0 to 220.5	1.0 T cells/million cells Interval 1.0 to 26.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20]	101.0 T cells/million cells Interval 18.0 to 206.0	1.0 T cells/million cells Interval 1.0 to 21.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20]	248.0 T cells/million cells Interval 158.0 to 455.0	1.0 T cells/million cells Interval 1.0 to 24.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D60[N=38;20]	174.0 T cells/million cells Interval 91.0 to 377.0	1.0 T cells/million cells Interval 1.0 to 23.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(-)D210[N=37;20]	1.0 T cells/million cells Interval 1.0 to 15.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19]	24.5 T cells/million cells Interval 1.0 to 61.0	25.0 T cells/million cells Interval 1.0 to 72.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15]	309.5 T cells/million cells Interval 64.5 to 972.0	29.0 T cells/million cells Interval 1.0 to 46.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20]	66.0 T cells/million cells Interval 41.0 to 198.0	25.0 T cells/million cells Interval 1.0 to 44.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20]	470.0 T cells/million cells Interval 238.0 to 874.0	23.5 T cells/million cells Interval 1.0 to 81.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20]	109.0 T cells/million cells Interval 67.0 to 229.0	20.0 T cells/million cells Interval 1.0 to 60.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(+)D210[N=37;20]	1.0 T cells/million cells Interval 1.0 to 16.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 28.0	1.0 T cells/million cells Interval 1.0 to 22.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D7[N=36;15]	232.5 T cells/million cells Interval 29.0 to 1233.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D30[N=39;20]	43.0 T cells/million cells Interval 1.0 to 183.0	1.0 T cells/million cells Interval 1.0 to 10.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20]	314.0 T cells/million cells Interval 154.0 to 890.0	11.5 T cells/million cells Interval 1.0 to 45.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20]	98.5 T cells/million cells Interval 27.0 to 258.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20]	29.0 T cells/million cells Interval 1.0 to 113.0	1.0 T cells/million cells Interval 1.0 to 7.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D0[N=38;19]	21.0 T cells/million cells Interval 1.0 to 33.0	24.0 T cells/million cells Interval 1.0 to 36.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D7[N=36;15]	64.5 T cells/million cells Interval 20.0 to 305.5	1.0 T cells/million cells Interval 1.0 to 34.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D30[N=39;20]	131.0 T cells/million cells Interval 58.0 to 338.0	22.0 T cells/million cells Interval 1.0 to 49.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(-)D37[N=39;20]	342.0 T cells/million cells Interval 179.0 to 549.0	1.0 T cells/million cells Interval 1.0 to 24.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 24.0	1.0 T cells/million cells Interval 1.0 to 27.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D7[N=36;15]	206.5 T cells/million cells Interval 36.0 to 692.5	1.0 T cells/million cells Interval 1.0 to 25.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D30[N=39;20]	62.0 T cells/million cells Interval 21.0 to 135.0	22.0 T cells/million cells Interval 1.0 to 35.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D37[N=39;20]	461.0 T cells/million cells Interval 133.0 to 738.0	1.0 T cells/million cells Interval 1.0 to 31.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(+)D60[N=38;20]	118.5 T cells/million cells Interval 68.0 to 308.0	21.5 T cells/million cells Interval 1.0 to 42.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 22.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D37[N=39;20]	112.0 T cells/million cells Interval 30.0 to 325.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D60[N=38;20]	59.0 T cells/million cells Interval 1.0 to 172.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(+)D210[N=37;20]	45.0 T cells/million cells Interval 15.0 to 217.0	1.0 T cells/million cells Interval 1.0 to 17.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19]	21.5 T cells/million cells Interval 1.0 to 86.0	1.0 T cells/million cells Interval 1.0 to 35.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15]	448.5 T cells/million cells Interval 42.5 to 2742.5	1.0 T cells/million cells Interval 1.0 to 59.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20]	606.0 T cells/million cells Interval 181.0 to 1878.0	22.0 T cells/million cells Interval 1.0 to 32.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20]	314.0 T cells/million cells Interval 111.0 to 580.0	22.5 T cells/million cells Interval 1.0 to 71.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(-)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20]	15.0 T cells/million cells Interval 1.0 to 30.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D0[N=38;19]	11.0 T cells/million cells Interval 1.0 to 46.0	1.0 T cells/million cells Interval 1.0 to 68.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D7[N=36;15]	443.0 T cells/million cells Interval 30.0 to 2485.5	21.0 T cells/million cells Interval 1.0 to 34.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D30[N=39;20]	121.0 T cells/million cells Interval 44.0 to 1202.0	1.0 T cells/million cells Interval 1.0 to 56.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D37[N=39;20]	505.0 T cells/million cells Interval 239.0 to 1790.0	43.0 T cells/million cells Interval 10.0 to 73.5
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D60[N=38;20]	346.5 T cells/million cells Interval 90.0 to 1102.0	23.5 T cells/million cells Interval 1.0 to 93.0
Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines CD4.CD40L(+)+IL-2(+)+TNFα(+)+IFNγ(+)D210[N=37;20]	560.0 T cells/million cells Interval 212.0 to 1230.0	49.0 T cells/million cells Interval 1.0 to 174.0

SECONDARY outcome

Timeframe: At Day 0, 7, 30, 37, 60 and 210

Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).

Outcome measures

SECONDARY outcome

Timeframe: At Day 0, 7, 30, 37, 60 and 210

Among cytokines expressed were interleukin-2 \[IL-2\], interferon-gamma \[IFN-γ\], tumour necrosis factor-alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40-L\], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).

Outcome measures

SECONDARY outcome

Timeframe: At Day 0, 30, 60 and 210

Antibody concentrations given in Enzyme-Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) were expressed as Geometric Mean Concentrations (GMCs).

Outcome measures

Outcome measures
Measure	GSK692342 Group n=39 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Anti-M72 Specific Antibody Concentrations Anti-M72, D30	22.2 EL.U/mL Interval 15.3 to 32.4	1.6 EL.U/mL Interval 1.2 to 2.2
Anti-M72 Specific Antibody Concentrations Anti-M72, D0	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	1077.8 EL.U/mL Interval 828.3 to 1402.5	1.8 EL.U/mL Interval 1.3 to 2.4
Anti-M72 Specific Antibody Concentrations Anti-M72, D210	121.9 EL.U/mL Interval 93.5 to 159.1	1.5 EL.U/mL Interval 1.3 to 1.7

Adverse Events

GSK692342 Group

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Measure	GSK692342 Group n=39 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 Participants Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D0[N=38;19]	20.5 T cells/million cells Interval 1.0 to 105.0	19.0 T cells/million cells Interval 1.0 to 182.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D7[N=36;15]	98.5 T cells/million cells Interval 1.0 to 186.0	1.0 T cells/million cells Interval 1.0 to 61.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D30[N=39;20]	2.0 T cells/million cells Interval 1.0 to 160.0	1.0 T cells/million cells Interval 1.0 to 6.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D37[N=39;20]	39.0 T cells/million cells Interval 1.0 to 168.0	42.0 T cells/million cells Interval 1.0 to 143.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D60[N=38;20]	5.0 T cells/million cells Interval 1.0 to 91.0	1.0 T cells/million cells Interval 1.0 to 141.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(-)D210[N=37;20]	28.0 T cells/million cells Interval 1.0 to 92.0	7.0 T cells/million cells Interval 1.0 to 108.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D0[N=38;19]	3.5 T cells/million cells Interval 1.0 to 93.0	1.0 T cells/million cells Interval 1.0 to 118.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15]	7.0 T cells/million cells Interval 1.0 to 73.5	1.0 T cells/million cells Interval 1.0 to 108.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20]	26.0 T cells/million cells Interval 1.0 to 106.0	5.5 T cells/million cells Interval 1.0 to 60.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20]	13.0 T cells/million cells Interval 1.0 to 94.0	35.5 T cells/million cells Interval 1.0 to 118.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20]	40.0 T cells/million cells Interval 1.0 to 131.0	109.5 T cells/million cells Interval 1.0 to 142.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20]	4.0 T cells/million cells Interval 1.0 to 107.0	34.5 T cells/million cells Interval 1.0 to 101.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19]	16.5 T cells/million cells Interval 1.0 to 71.0	1.0 T cells/million cells Interval 1.0 to 66.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15]	1.0 T cells/million cells Interval 1.0 to 94.0	8.0 T cells/million cells Interval 1.0 to 130.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20]	1.0 T cells/million cells Interval 1.0 to 62.0	1.0 T cells/million cells Interval 1.0 to 47.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20]	1.0 T cells/million cells Interval 1.0 to 46.0	1.0 T cells/million cells Interval 1.0 to 50.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20]	1.0 T cells/million cells Interval 1.0 to 74.0	8.0 T cells/million cells Interval 1.0 to 40.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20]	1.0 T cells/million cells Interval 1.0 to 36.0	1.0 T cells/million cells Interval 1.0 to 43.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19]	66.0 T cells/million cells Interval 1.0 to 182.0	87.0 T cells/million cells Interval 1.0 to 196.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15]	303.0 T cells/million cells Interval 84.0 to 541.0	109.0 T cells/million cells Interval 1.0 to 186.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20]	93.0 T cells/million cells Interval 1.0 to 143.0	76.5 T cells/million cells Interval 26.0 to 256.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20]	190.0 T cells/million cells Interval 33.0 to 301.0	95.0 T cells/million cells Interval 7.0 to 321.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20]	70.5 T cells/million cells Interval 21.0 to 261.0	104.5 T cells/million cells Interval 32.5 to 296.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(-)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20]	61.0 T cells/million cells Interval 1.0 to 135.0	37.5 T cells/million cells Interval 1.0 to 104.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D7[N=36;15]	1.0 T cells/million cells Interval 1.0 to 33.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D30[N=39;20]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D37[N=39;20]	1.0 T cells/million cells Interval 1.0 to 46.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D60[N=38;20]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(+)+TNFα(-)+IFNγ(-)D210[N=37;20]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D7[N=36;15]	1.0 T cells/million cells Interval 1.0 to 10.5	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D30[N=39;20]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D37[N=39;20]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D60[N=38;20]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(+)+IFNγ(-)D210[N=37;20]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D0[N=38;19]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 27.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D7[N=36;15]	94.0 T cells/million cells Interval 1.0 to 257.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D30[N=39;20]	1.0 T cells/million cells Interval 1.0 to 1.0	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D37[N=39;20]	33.0 T cells/million cells Interval 1.0 to 187.0	1.0 T cells/million cells Interval 1.0 to 10.5
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D60[N=38;20]	1.0 T cells/million cells Interval 1.0 to 28.0	1.0 T cells/million cells Interval 1.0 to 39.0
Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines CD8.CD40L(+)+IL-2(-)+TNFα(-)+IFNγ(+)D210[N=37;20]	24.0 T cells/million cells Interval 1.0 to 51.0	18.5 T cells/million cells Interval 1.0 to 74.5

Measure	GSK692342 Group n=40 participants at risk Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm's deltoid region.	Placebo Group n=20 participants at risk Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm's deltoid region.
General disorders Pain	95.0% 38/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	35.0% 7/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
General disorders Redness (millimeters)	32.5% 13/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	10.0% 2/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
General disorders Swelling (millimeters)	50.0% 20/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	10.0% 2/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
General disorders Fatigue	52.5% 21/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	25.0% 5/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
General disorders Gastrointestinal	45.0% 18/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	25.0% 5/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
General disorders Headache	70.0% 28/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	25.0% 5/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
General disorders Malaise	35.0% 14/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	15.0% 3/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
General disorders Myalgia	17.5% 7/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	10.0% 2/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
General disorders Temperature/(Orally) (°C)	60.0% 24/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	10.0% 2/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
Gastrointestinal disorders Diarrhoea	0.00% 0/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	5.0% 1/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
Infections and infestations Nasopharyngitis	7.5% 3/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	0.00% 0/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
Injury, poisoning and procedural complications Joint injury	0.00% 0/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	5.0% 1/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
Injury, poisoning and procedural complications Joint sprain	0.00% 0/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	5.0% 1/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
Investigations Alanine aminotransferase increased	5.0% 2/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	0.00% 0/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
Investigations Haemoglobin decreased	5.0% 2/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	0.00% 0/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
Investigations White blood cell count decreased	5.0% 2/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	0.00% 0/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
Nervous system disorders Dizziness	0.00% 0/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	5.0% 1/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210
Reproductive system and breast disorders Dysmenorrhoea	5.0% 2/40 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210	15.0% 3/20 • Solicited local/general symptoms during the 7-day post vaccination period (Days 0-6); AEs during the 30-day post vaccination period (Days 0-29), SAEs up to Day 210