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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00621322
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : February 3, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Tuberculosis
Interventions Biological: GSK Biologicals' AS01B adjuvant
Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1
Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2
Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3
Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1
Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Period Title: Overall Study
Started 10 10 40 40 40 40
Completed 9 10 38 37 39 36
Not Completed 1 0 2 3 1 4
Reason Not Completed
Lost to Follow-up             0             0             0             0             1             0
Physician Decision             0             0             1             1             0             0
Withdrawal by Subject             0             0             0             1             0             2
Migrated/moved from study area             1             0             1             1             0             2
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group Total
Hide Arm/Group Description Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 10 10 40 40 40 40 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 40 participants 40 participants 40 participants 40 participants 180 participants
32.1  (8.10) 36.0  (5.14) 30.6  (9.14) 33.5  (8.73) 30.6  (9.17) 31.5  (8.83) 31.92  (8.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 40 participants 40 participants 40 participants 40 participants 180 participants
Female
9
  90.0%
7
  70.0%
33
  82.5%
36
  90.0%
31
  77.5%
26
  65.0%
142
  78.9%
Male
1
  10.0%
3
  30.0%
7
  17.5%
4
  10.0%
9
  22.5%
14
  35.0%
38
  21.1%
1.Primary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.
Time Frame During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Measure Type: Number
Unit of Measure: Subjects
Any Pain, Dose 1 8 3 35 33 33 32
Grade 3 Pain, Dose 1 0 0 0 0 0 1
Any Redness, Dose 1 1 2 7 3 4 3
Grade 3 Redness, Dose 1 0 0 0 0 0 0
Any Swelling, Dose 1 0 0 8 6 7 6
Grade 3 Swelling, Dose 1 0 0 0 0 0 1
Any Pain, Dose 2 7 4 33 32 36 33
Grade 3 Pain, Dose 2 0 0 0 0 0 1
Any Redness, Dose 2 0 1 0 5 4 5
Grade 3 Redness, Dose 2 0 0 0 0 1 1
Any Swelling, Dose 2 1 1 5 5 7 8
Grade 3 Swelling, Dose 2 0 0 0 1 1 1
Any Pain, Across 9 5 38 37 37 36
Grade 3 Pain, Across 0 0 0 0 0 2
Any Redness, Across 1 2 7 6 6 6
Grade 3 Redness, Across 0 0 0 0 1 1
Any Swelling, Across 1 1 10 10 12 12
Grade 3 Swelling, Across 0 0 0 1 1 2
2.Primary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description Assessed solicited general symptoms included fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Measure Type: Number
Unit of Measure: Subjects
Any Fatigue, Dose 1 1 1 4 5 7 3
Grade 3 Fatigue, Dose 1 0 0 0 0 0 0
Related Fatigue, Dose 1 0 0 1 3 4 2
Any Gastro, Dose 1 2 3 5 3 5 7
Grade 3 Gastro, Dose 1 0 0 0 0 0 0
Related Gastro, Dose 1 2 0 3 1 1 2
Any Headache, Dose 1 4 4 11 16 15 19
Grade 3 Headache, Dose 1 1 1 0 0 0 0
Related Headache, Dose 1 2 0 7 8 7 10
Any Malaise, Dose 1 3 3 9 13 10 18
Grade 3 Malaise, Dose 1 0 0 0 0 0 0
Related Malaise, Dose 1 2 0 7 8 8 16
Any Myalgia, Dose 1 1 3 14 10 13 14
Grade 3 Myalgia, Dose 1 0 0 0 0 0 0
Related Myalgia, Dose 1 1 1 9 6 11 13
Any Temperature, Dose 1 2 1 3 2 3 9
Grade 3 Temperature, Dose 1 0 0 0 0 0 2
Related Temperature, Dose 1 1 0 3 1 2 8
Any Fatigue, Dose 2 1 1 5 6 8 8
Grade 3 Fatigue, Dose 2 0 0 0 0 0 0
Related Fatigue, Dose 2 1 1 4 3 6 7
Any Gastro, Dose 2 1 1 5 7 8 9
Grade 3 Gastro, Dose 2 0 0 0 0 1 0
Related Gastro, Dose 2 0 0 1 1 7 8
Any Headache, Dose 2 5 3 22 20 29 26
Grade 3 Headache, Dose 2 0 0 1 0 1 1
Related Headache, Dose 2 1 1 13 8 24 22
Any Malaise, Dose 2 5 1 22 21 21 25
Grade 3 Malaise, Dose 2 0 0 1 0 0 1
Related Malaise, Dose 2 4 1 21 17 21 24
Any Myalgia, Dose 2 3 1 18 21 23 28
Grade 3 Myalgia, Dose 2 0 0 1 0 2 1
Related Myalgia, Dose 2 2 1 18 20 23 28
Any Temperature, Dose 2 3 0 15 8 16 27
Grade 3 Temperature, Dose 2 0 0 2 0 1 3
Related Temperature, Dose 2 2 0 13 7 15 27
Any Fatigue, Across 2 1 7 8 13 10
Grade 3 Fatigue, Across 0 0 0 0 0 0
Related Fatigue, Across 1 1 4 6 9 8
Any Gastro, Across 3 3 8 9 11 10
Grade 3 Gastro, Across 0 0 0 0 1 0
Related Gastro, Across 2 0 4 2 8 8
Any Headache, Across 5 6 25 27 30 26
Grade 3 Headache, Across 1 1 1 0 1 1
Related Headache, Across 3 1 18 15 24 23
Any Malaise, Across 5 3 23 25 23 26
Grade 3 Malaise, Across 0 0 1 0 0 1
Related Malaise, Across 5 1 22 21 23 26
Any Myalgia, Across 3 3 25 23 24 29
Grade 3 Myalgia, Across 0 0 1 0 2 1
Related Myalgia, Across 2 2 24 22 24 29
Any Temperature, Across 5 1 17 9 17 28
Grade 3 Temperature, Across 0 0 2 0 1 4
Related Temperature, Across 3 0 15 7 15 28
3.Primary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame During the 30-day (Days 0-29) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Measure Type: Number
Unit of Measure: Subjects
Any AEs 7 9 29 33 33 27
Grade 3 AEs 0 0 1 1 0 0
Related AEs 0 1 7 2 5 2
4.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame During the entire study period (from Day 0 up to Day 210)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Measure Type: Number
Unit of Measure: Subjects
0 0 2 0 2 0
5.Primary Outcome
Title Number of Subjects With Different Biochemical and Haematological Levels
Hide Description Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Measure Type: Number
Unit of Measure: Subjects
ALT, Normal 10 10 40 38 38 37
ALT, Below 0 0 0 0 0 0
ALT, Above 0 0 0 1 2 3
ALT, Missing 0 0 0 1 0 0
AST, Normal 9 9 40 38 37 38
AST, Below 0 0 0 0 0 0
AST, Above 1 1 0 1 3 2
AST, Missing 0 0 0 1 0 0
BAS, Normal 3 10 11 18 40 39
BAS, Below 0 0 0 0 0 0
BAS, Above 0 0 0 0 0 0
BAS, Missing 7 0 29 22 0 1
CREA, Normal 9 10 38 38 39 39
CREA, Below 1 0 2 1 1 1
CREA, Above 0 0 0 0 0 0
CREA, Missing 0 0 0 1 0 0
EOS, Normal 9 8 38 38 33 34
EOS, Below 0 0 1 1 0 0
EOS, Above 1 2 0 1 7 5
EOS, Missing 0 0 1 0 0 1
Hct, Normal 10 9 38 39 37 35
Hct, Below 0 1 1 1 3 4
Hct, Above 0 0 0 0 0 0
Hct, Missing 0 0 1 0 0 1
Hgb, Normal 10 8 39 39 38 36
Hgb, Below 0 2 0 1 2 3
Hgb, Above 0 0 0 0 0 0
Hgb, Missing 0 0 1 0 0 1
LYM, Normal 9 10 38 37 39 37
LYM, Below 1 0 1 3 1 2
LYM, Above 0 0 0 0 0 0
LYM, Missing 0 0 1 0 0 1
MON, Normal 10 9 39 40 38 38
MON, Below 0 1 0 0 2 1
MON, Above 0 0 0 0 0 0
MON, Missing 0 0 1 0 0 1
NEU, Normal 9 10 35 36 37 36
NEU, Below 0 0 0 0 0 0
NEU, Above 1 0 4 4 3 3
NEU, Missing 0 0 1 0 0 1
PLA, Normal 10 10 39 40 40 39
PLA, Below 0 0 0 0 0 0
PLA, Above 0 0 0 0 0 0
PLA, Missing 0 0 1 0 0 1
RBC, Normal 9 7 36 35 36 35
RBC, Below 1 1 2 1 2 4
RBC, Above 0 2 1 4 2 0
RBC, Missing 0 0 1 0 0 1
WBC, Normal 10 9 37 31 30 36
WBC, Below 0 0 0 0 1 0
WBC, Above 0 1 2 9 9 3
WBC, Missing 0 0 1 0 0 1
6.Primary Outcome
Title Number of Subjects With Different Biochemical and Haematological Levels
Hide Description Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time Frame At Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Measure Type: Number
Unit of Measure: Subjects
ALT, Normal 10 10 36 32 38 34
ALT, Below 0 0 1 0 0 1
ALT, Above 0 0 2 7 2 4
ALT, Missing 0 0 0 1 0 0
AST, Normal 10 10 39 36 40 37
AST, Below 0 0 0 0 0 0
AST, Above 0 0 0 3 0 2
AST, Missing 0 0 1 1 1 1
BAS, Normal 2 10 1 7 40 39
BAS, Below 0 0 0 0 0 0
BAS, Above 0 0 0 0 0 0
BAS, Missing 8 0 39 33 0 1
CREA, Normal 10 10 38 36 39 39
CREA, Below 0 0 0 0 1 0
CREA, Above 0 0 1 3 0 0
CREA, Missing 0 0 1 1 0 1
EOS, Normal 10 6 38 38 32 31
EOS, Below 0 0 0 0 0 0
EOS, Above 0 4 1 2 8 8
EOS, Missing 0 0 1 0 0 1
Hct, Normal 10 8 37 37 34 33
Hct, Below 0 2 2 3 6 6
Hct, Above 0 0 0 0 0 0
Hct, Missing 0 0 1 0 0 1
Hgb, Normal 10 7 39 38 33 36
Hgb, Below 0 3 0 2 7 3
Hgb, Above 0 0 0 0 0 0
Hgb, Missing 0 0 1 0 0 1
LYM, Normal 10 10 38 40 40 38
LYM, Below 0 0 1 0 0 1
LYM, Above 0 0 0 0 0 0
LYM, Missing 0 0 1 0 0 1
MON, Normal 10 9 39 40 38 39
MON, Below 0 1 0 0 2 0
MON, Above 0 0 0 0 0 0
MON, Missing 0 0 1 0 0 1
NEU, Normal 9 10 38 40 40 38
NEU, Below 0 0 0 0 0 0
NEU, Above 1 0 1 0 0 1
NEU, Missing 0 0 1 0 0 1
PLA, Normal 10 9 39 40 39 39
PLA, Below 0 0 0 0 0 0
PLA, Above 0 1 0 0 1 0
PLA, Missing 0 0 1 0 0 1
RBC, Normal 8 8 33 33 34 33
RBC, Below 2 1 5 5 5 6
RBC, Above 0 1 1 2 1 0
RBC, Missing 0 0 1 0 0 1
WBC, Normal 9 9 33 37 31 35
WBC, Below 0 0 0 0 2 0
WBC, Above 1 1 6 3 7 4
WBC, Missing 0 0 1 0 0 1
7.Primary Outcome
Title Number of Subjects With Different Biochemical and Haematological Levels
Hide Description Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time Frame At Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Measure Type: Number
Unit of Measure: Subjects
ALT, Normal 9 9 38 36 36 38
ALT, Below 0 0 0 0 1 0
ALT, Above 1 1 1 2 3 1
ALT, Missing 0 0 1 2 0 1
AST, Normal 10 10 38 35 37 37
AST, Below 0 0 0 0 0 0
AST, Above 0 0 1 3 3 2
AST, Missing 0 0 1 2 0 1
BAS, Normal 4 10 5 13 39 39
BAS, Below 0 0 0 0 0 0
BAS, Above 0 0 0 0 0 0
BAS, Missing 6 0 35 27 1 1
CREA, Normal 10 9 39 37 36 37
CREA, Below 0 0 0 0 3 0
CREA, Above 0 1 0 1 1 2
CREA, Missing 0 0 1 2 0 1
EOS, Normal 8 8 37 35 28 30
EOS, Below 0 0 1 0 0 0
EOS, Above 1 2 1 5 11 9
EOS, Missing 1 0 1 0 1 1
Hct, Normal 8 7 36 34 34 35
Hct, Below 1 3 3 5 5 4
Hct, Above 0 0 0 1 0 0
Hct, Missing 1 0 1 0 1 1
Hgb, Normal 8 7 38 35 33 36
Hgb, Below 1 3 1 4 6 3
Hgb, Above 0 0 0 1 0 0
Hgb, Missing 1 0 1 0 1 1
LYM, Normal 9 9 38 40 39 36
LYM, Below 0 1 1 0 0 3
LYM, Above 0 0 0 0 0 0
LYM, Missing 1 0 1 0 1 1
MON, Normal 9 10 39 40 39 39
MON, Below 0 0 0 0 0 0
MON, Above 0 0 0 0 0 0
MON, Missing 1 0 1 0 1 1
NEU, Normal 9 10 38 39 38 39
NEU, Below 0 0 0 0 0 0
NEU, Above 0 0 1 1 1 0
NEU, Missing 1 0 1 0 1 1
PLA, Normal 9 10 39 40 38 39
PLA, Below 0 0 0 0 1 0
PLA, Above 0 0 0 0 0 0
PLA, Missing 1 0 1 0 1 1
RBC, Normal 9 8 36 36 36 36
RBC, Below 0 1 2 2 2 3
RBC, Above 0 1 1 2 1 0
RBC, Missing 1 0 1 0 1 1
WBC, Normal 9 8 35 37 33 36
WBC, Below 0 0 0 0 3 0
WBC, Above 0 2 4 3 3 3
WBC, Missing 1 0 1 0 1 1
8.Primary Outcome
Title Number of Subjects With Different Biochemical and Haematological Levels
Hide Description Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time Frame At Day 37
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Measure Type: Number
Unit of Measure: Subjects
ALT, Normal 9 10 37 36 34 35
ALT, Below 0 0 0 0 0 0
ALT, Above 1 0 2 3 6 4
ALT, Missing 0 0 1 1 0 1
AST, Normal 10 10 37 38 37 36
AST, Below 0 0 0 0 0 0
AST, Above 0 0 2 1 3 3
AST, Missing 0 0 1 1 1 1
BAS, Normal 4 10 10 15 40 39
BAS, Below 0 0 0 0 0 0
BAS, Above 0 0 0 0 0 0
BAS, Missing 6 0 0 25 0 1
CREA, Normal 10 9 38 39 38 39
CREA, Above 0 0 0 0 2 0
CREA, Below 0 1 1 0 0 0
CREA, Missing 0 0 1 1 0 1
EOS, Normal 6 7 35 36 33 33
EOS, Below 0 0 1 0 0 0
EOS, Above 4 3 3 3 7 6
EOS, Missing 0 0 1 1 0 1
Hct, Normal 8 7 34 32 35 35
Hct, Below 2 3 5 6 5 4
Hct, Above 0 0 0 1 0 0
Hct, Missing 0 0 1 1 0 1
Hgb, Normal 9 6 36 34 36 36
Hgb, Below 1 4 3 4 4 3
Hgb, Above 0 0 0 1 0 0
Hgb, Missing 0 0 1 1 0 1
LYM, Normal 10 10 38 38 39 39
LYM, Below 0 0 1 0 1 0
LYM, Above 0 0 0 1 0 0
LYM, Missing 0 0 1 1 0 1
MON, Normal 10 10 39 38 39 39
MON, Below 0 0 0 0 1 0
MON, Above 0 0 0 1 0 0
MON, Missing 0 0 1 1 0 1
NEU, Normal 10 10 38 38 39 37
NEU, Below 0 0 0 1 0 1
NEU, Above 0 0 1 0 1 1
NEU, Missing 0 0 1 1 0 1
PLA, Normal 10 9 37 39 40 39
PLA, Below 0 0 0 0 0 0
PLA, Above 0 1 2 0 0 0
PLA, Missing 0 0 1 1 0 1
RBC, Normal 9 8 34 35 36 33
RBC, Below 1 1 5 2 3 6
RBC, Above 0 1 0 2 1 0
RBC, Missing 0 0 1 1 0 1
WBC, Normal 9 7 32 35 33 34
WBC, Below 0 0 0 1 0 0
WBC, Above 1 3 7 3 7 5
WBC, Missing 0 0 1 1 0 1
9.Primary Outcome
Title Number of Subjects With Different Biochemical and Haematological Levels
Hide Description Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.
Time Frame At Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Measure Type: Number
Unit of Measure: Subjects
ALT, Normal 9 9 38 37 38 34
ALT, Below 0 0 0 0 0 0
ALT, Above 1 1 1 2 2 5
ALT, Missing 0 0 1 1 0 1
AST, Normal 9 9 38 37 38 37
AST, Below 0 0 0 0 0 0
AST, Above 1 1 1 2 2 2
AST, Missing 0 0 1 1 0 1
BAS, Normal 10 10 38 39 40 39
BAS, Below 0 0 0 0 0 0
BAS, Above 0 0 0 0 0 0
BAS, Missing 0 0 2 1 0 1
CREA, Normal 10 9 38 37 39 39
CREA, Below 0 1 1 2 1 0
CREA, Above 0 0 0 0 0 0
CREA, Missing 0 0 1 1 0 1
EOS, Normal 7 7 34 36 32 31
EOS, Below 0 0 0 0 0 0
EOS, Above 3 3 4 3 8 8
EOS, Missing 0 0 2 1 0 1
Hct, Normal 9 8 33 36 36 36
Hct, Below 1 2 5 2 4 3
Hct, Above 0 0 0 1 0 0
Hct, Missing 0 0 2 1 0 1
Hgb, Normal 9 8 35 36 37 36
Hgb, Below 1 2 3 2 3 3
Hgb, Above 0 0 0 1 0 0
Hgb, Missing 0 0 2 1 0 1
LYM, Normal 10 8 38 39 38 37
LYM, Below 0 2 0 0 2 2
LYM, Above 0 0 0 0 0 0
LYM, Missing 0 0 2 1 0 1
MON, Normal 10 9 37 39 40 39
MON, Below 0 1 1 0 0 0
MON, Above 0 0 0 0 0 0
MON, Missing 0 0 2 1 0 1
NEU, Normal 9 8 38 39 37 37
NEU, Below 0 0 0 0 0 0
NEU, Above 1 2 0 0 3 2
NEU, Missing 0 0 2 1 0 1
PLA, Normal 10 9 38 38 40 39
PLA, Below 0 0 0 0 0 0
PLA, Above 0 1 0 1 0 0
PLA, Missing 0 0 2 1 0 1
RBC, Normal 9 8 36 35 37 36
RBC, Below 1 1 2 3 2 3
RBC, Above 0 1 0 1 1 0
RBC, Missing 0 0 2 1 0 1
WBC, Normal 8 7 34 37 36 31
WBC, Below 0 0 0 0 1 1
WBC, Above 2 3 4 2 3 7
WBC, Missing 0 0 2 1 0 1
10.Secondary Outcome
Title Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
Hide Description 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).
Time Frame At Day 0, 30, 60 and 210
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
CD4-All Doubles, D0 [N=9;9;38;34;40;39]
173.0
(94.0 to 466.0)
293.0
(213.0 to 853.0)
200.0
(87.0 to 537.0)
241.0
(147.0 to 547.0)
263.5
(80.5 to 528.5)
312.0
(133.0 to 488.0)
CD4-All Doubles, D30 [N=10;10;38;36;39;37]
245.5
(80.0 to 387.0)
1013.5
(491.0 to 3227.0)
2833.0
(1440.0 to 5120.0)
1653.5
(886.5 to 3587.0)
2653.0
(1480.0 to 4826.0)
3280.0
(2267.0 to 6928.0)
CD4-All Doubles, D60 [N=10;9;38;36;38;37]
139.5
(27.0 to 187.0)
2133.0
(640.0 to 3240.0)
6307.0
(3560.0 to 9307.0)
3855.5
(2353.5 to 5220.0)
4880.0
(3147.0 to 6853.0)
5133.0
(3227.0 to 7733.0)
CD4-All Doubles, D210 [N=9;7;37;32;35;34]
106.0
(91.0 to 414.0)
1426.0
(949.0 to 2814.0)
3826.0
(2467.0 to 5907.0)
2486.5
(1660.0 to 4075.0)
3240.0
(2520.0 to 5360.0)
3633.5
(2733.0 to 5253.0)
CD8-All Doubles, D0 [N=9;9;38;34;40;39]
1.0
(1.0 to 65.0)
5.0
(1.0 to 35.0)
17.0
(1.0 to 104.0)
33.0
(1.0 to 85.0)
9.0
(1.0 to 91.0)
18.0
(1.0 to 79.0)
CD8-All Doubles, D30 [N=10;10;38;36;39;37]
31.0
(1.0 to 46.0)
20.5
(1.0 to 146.0)
39.5
(1.0 to 102.0)
14.0
(1.0 to 77.5)
26.0
(1.0 to 287.0)
34.0
(1.0 to 90.0)
CD8-All Doubles, D60 [N=10;9;38;36;38;37]
9.5
(1.0 to 175.0)
16.0
(1.0 to 33.0)
1.0
(1.0 to 71.0)
10.0
(1.0 to 86.5)
59.0
(1.0 to 167.0)
16.0
(1.0 to 107.0)
CD8-All Doubles, D210 [N=9;7;37;32;35;34]
1.0
(1.0 to 179.0)
1.0
(1.0 to 28.0)
1.0
(1.0 to 35.0)
1.0
(1.0 to 84.0)
54.0
(2.0 to 124.0)
24.5
(1.0 to 46.0)
11.Secondary Outcome
Title Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
Hide Description

Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.

For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.

Time Frame At Day 0, 30, 60 and 210
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
CD4-CD40-L, D0 [N=9;9;38;34;40;39]
104.0
(66.0 to 306.0)
227.0
(186.0 to 840.0)
147.0
(41.0 to 254.0)
151.0
(107.0 to 320.0)
210.5
(73.0 to 388.0)
261.0
(94.0 to 418.0)
CD4-CD40-L, D30 [N=10;10;38;36;39;37]
188.0
(40.0 to 307.0)
853.0
(427.0 to 3133.0)
1934.0
(1333.0 to 3600.0)
1280.0
(833.5 to 2219.5)
2334.0
(1387.0 to 3700.0)
3213.0
(1853.0 to 6801.0)
CD4-CD40-L, D60 [N=10;9;38;36;38;37]
87.0
(1.0 to 227.0)
1986.0
(560.0 to 3173.0)
5413.5
(2535.0 to 7235.0)
2813.5
(1740.0 to 4293.5)
4384.5
(2826.0 to 5813.0)
4680.0
(3120.0 to 6547.0)
CD4-CD40-L, D210 [N=9;7;37;32;35;34]
120.0
(80.0 to 380.0)
1374.0
(920.0 to 2693.0)
3727.0
(2431.0 to 5733.0)
2424.5
(1586.5 to 3744.0)
3173.0
(2333.0 to 5307.0)
3540.0
(2486.0 to 5025.0)
CD40-IL-2, D0 [N=9;9;38;34;40;39]
146.0
(93.0 to 467.0)
333.0
(207.0 to 787.0)
173.0
(66.0 to 373.0)
224.0
(80.0 to 477.0)
202.5
(73.5 to 413.0)
226.0
(67.0 to 360.0)
CD4-IL-2, D30 [N=10;10;38;36;39;37]
218.5
(40.0 to 320.0)
1046.5
(453.0 to 2356.0)
2560.0
(1426.0 to 4680.0)
1460.0
(827.0 to 3093.5)
2520.0
(1147.0 to 4186.0)
3120.0
(1806.0 to 6546.0)
CD4-IL-2, D60 [N=10;9;38;36;38;37]
107.0
(34.0 to 200.0)
1773.0
(533.0 to 2840.0)
5704.0
(3284.0 to 7947.0)
3068.5
(2055.5 to 4473.0)
4460.0
(2762.0 to 5591.0)
4414.0
(2894.0 to 7027.0)
CD4-IL-2, D210 [N=9;7;37;32;35;34]
114.0
(66.0 to 312.0)
1427.0
(840.0 to 2227.0)
3240.0
(2360.0 to 5813.0)
2180.0
(1526.5 to 3569.5)
3080.0
(2293.0 to 5226.0)
3533.5
(2400.0 to 5037.0)
CD40-TNF-α, D0 [N=9;9;38;34;40;39]
78.0
(53.0 to 334.0)
220.0
(146.0 to 640.0)
143.5
(67.0 to 493.0)
180.5
(79.0 to 449.0)
177.5
(56.0 to 398.0)
160.0
(29.0 to 293.0)
CD4-TNF-α, D30 [N=10;10;38;36;39;37]
185.5
(93.0 to 346.0)
733.5
(345.0 to 2360.0)
2028.0
(1013.0 to 4080.0)
1140.0
(473.5 to 3026.5)
1534.0
(867.0 to 3813.0)
2133.0
(867.0 to 4480.0)
CD4-TNF-α, D60 [N=10;9;38;36;38;37]
73.0
(1.0 to 226.0)
907.0
(427.0 to 1373.0)
3993.5
(1788.0 to 7223.0)
2086.5
(1306.5 to 3754.0)
3019.5
(1790.0 to 3776.0)
2867.0
(1510.0 to 4200.0)
CD4-TNF-α, D210 [N=9;7;37;32;35;34]
72.0
(1.0 to 379.0)
1106.0
(718.0 to 2307.0)
2960.0
(1613.0 to 4987.0)
1831.0
(1086.0 to 3096.0)
2305.0
(1694.0 to 4133.0)
2580.0
(1840.0 to 4240.0)
CD40-IFN-γ, D0 [N=9;9;38;34;40;39]
134.0
(13.0 to 480.0)
258.0
(214.0 to 840.0)
180.5
(67.0 to 471.0)
193.5
(69.0 to 435.0)
233.5
(67.0 to 493.5)
306.0
(146.0 to 483.0)
CD4-IFN-γ, D30 [N=10;10;38;36;39;37]
206.5
(54.0 to 279.0)
626.5
(333.0 to 2306.0)
1477.0
(496.0 to 3675.0)
938.5
(347.5 to 2500.0)
1097.0
(654.0 to 3440.0)
1733.0
(698.0 to 4688.0)
CD4-IFN-γ, D60 [N=10;9;38;36;38;37]
111.0
(40.0 to 266.0)
1014.0
(320.0 to 1480.0)
3070.5
(1134.0 to 4794.0)
1233.0
(667.0 to 2946.5)
2016.0
(1253.0 to 3010.0)
2453.0
(1320.0 to 3853.0)
CD4-IFN-γ, D210 [N=9;7;37;32;35;34]
146.0
(107.0 to 360.0)
933.0
(336.0 to 1826.0)
1907.0
(827.0 to 3413.0)
927.0
(483.5 to 1823.5)
1413.0
(915.0 to 2054.0)
1711.0
(892.0 to 2310.0)
12.Secondary Outcome
Title Anti-M72 Specific Antibody Concentrations
Hide Description Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).
Time Frame At Day 0, 30, 60 and 210
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description:
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Overall Number of Participants Analyzed 10 10 40 40 40 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-M72, D0 [N=10;10;39;38;40;39]
1.4
(1.4 to 1.4)
1.4
(1.4 to 1.4)
1.4
(1.4 to 1.4)
1.4
(1.4 to 1.4)
1.4
(1.4 to 1.4)
1.4
(1.4 to 1.4)
Anti-M72, D30 [N=10;10;39;38;40;39]
1.4
(1.4 to 1.4)
2.9
(1.4 to 6.0)
4.9
(3.5 to 6.9)
5.5
(4.1 to 7.4)
8.7
(6.5 to 11.7)
15.0
(11.2 to 20.0)
Anti-M72, D60 [N=10;10;39;38;40;39]
1.4
(1.4 to 1.4)
31.0
(7.3 to 132.0)
458.4
(365.2 to 575.4)
468.5
(367.0 to 598.0)
598.6
(504.0 to 710.9)
833.0
(696.2 to 996.7)
Anti-M72, D210 [N=9;10;38;36;39;36]
1.4
(1.4 to 1.4)
6.1
(2.1 to 17.8)
51.1
(37.5 to 69.8)
46.3
(37.2 to 57.6)
70.7
(57.5 to 87.0)
85.2
(71.3 to 101.9)
Time Frame Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Hide Arm/Group Description Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm. Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
All-Cause Mortality
Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   2/40 (5.00%)   0/40 (0.00%)   2/40 (5.00%)   0/40 (0.00%) 
Gastrointestinal disorders             
Food poisoning  1  0/10 (0.00%)  0/10 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Infections and infestations             
Dengue fever  1  0/10 (0.00%)  0/10 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%) 
Pyelonephritis acute  1  0/10 (0.00%)  0/10 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%) 
Typhoid fever  1  0/10 (0.00%)  0/10 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%) 
Metabolism and nutrition disorders             
Type 2 diabetes mellitus  1  0/10 (0.00%)  0/10 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Asthma  1  0/10 (0.00%)  0/10 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Group GSK692342_F1 Group GSK692342_F2 Group GSK692342_F3 Group GSK692342_F4D1 Group GSK692342_F4D2 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   9/10 (90.00%)   40/40 (100.00%)   39/40 (97.50%)   39/40 (97.50%)   38/40 (95.00%) 
Gastrointestinal disorders             
Diarrhoea  1  1/10 (10.00%)  0/10 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  3/40 (7.50%)  1/40 (2.50%) 
Toothache  1  1/10 (10.00%)  0/10 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  3/40 (7.50%)  1/40 (2.50%) 
General disorders             
Pain  1  9/10 (90.00%)  5/10 (50.00%)  38/40 (95.00%)  37/40 (92.50%)  37/40 (92.50%)  36/40 (90.00%) 
Redness  1  1/10 (10.00%)  2/10 (20.00%)  7/40 (17.50%)  6/40 (15.00%)  6/40 (15.00%)  6/40 (15.00%) 
Swelling  1  1/10 (10.00%)  1/10 (10.00%)  10/40 (25.00%)  10/40 (25.00%)  12/40 (30.00%)  12/40 (30.00%) 
Fatigue  1  2/10 (20.00%)  1/10 (10.00%)  7/40 (17.50%)  8/40 (20.00%)  13/40 (32.50%)  10/40 (25.00%) 
Gastro-intestinal symptoms  1  3/10 (30.00%)  3/10 (30.00%)  8/40 (20.00%)  9/40 (22.50%)  11/40 (27.50%)  10/40 (25.00%) 
Headache  1  5/10 (50.00%)  6/10 (60.00%)  25/40 (62.50%)  27/40 (67.50%)  30/40 (75.00%)  26/40 (65.00%) 
Malaise  1  5/10 (50.00%)  3/10 (30.00%)  23/40 (57.50%)  25/40 (62.50%)  23/40 (57.50%)  26/40 (65.00%) 
Myalgia  1  3/10 (30.00%)  3/10 (30.00%)  25/40 (62.50%)  23/40 (57.50%)  24/40 (60.00%)  29/40 (72.50%) 
Temperature (Axillary)  1  5/10 (50.00%)  1/10 (10.00%)  17/40 (42.50%)  9/40 (22.50%)  17/40 (42.50%)  28/40 (70.00%) 
Pyrexia  1  1/10 (10.00%)  3/10 (30.00%)  4/40 (10.00%)  4/40 (10.00%)  5/40 (12.50%)  3/40 (7.50%) 
Feeling hot  1  0/10 (0.00%)  0/10 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  4/40 (10.00%)  1/40 (2.50%) 
Chills  1  0/10 (0.00%)  0/10 (0.00%)  3/40 (7.50%)  1/40 (2.50%)  1/40 (2.50%)  1/40 (2.50%) 
Malaise  1  0/10 (0.00%)  3/10 (30.00%)  0/40 (0.00%)  0/40 (0.00%)  2/40 (5.00%)  2/40 (5.00%) 
Infections and infestations             
Nasopharyngitis  1  4/10 (40.00%)  5/10 (50.00%)  15/40 (37.50%)  10/40 (25.00%)  18/40 (45.00%)  16/40 (40.00%) 
Injury, poisoning and procedural complications             
Wound  1  1/10 (10.00%)  0/10 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders             
Myalgia  1  2/10 (20.00%)  2/10 (20.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%) 
Nervous system disorders             
Headache  1  2/10 (20.00%)  3/10 (30.00%)  5/40 (12.50%)  7/40 (17.50%)  11/40 (27.50%)  7/40 (17.50%) 
Dizziness  1  2/10 (20.00%)  1/10 (10.00%)  1/40 (2.50%)  5/40 (12.50%)  4/40 (10.00%)  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  0/10 (0.00%)  4/10 (40.00%)  3/40 (7.50%)  6/40 (15.00%)  13/40 (32.50%)  11/40 (27.50%) 
Oropharyngeal pain  1  0/10 (0.00%)  0/10 (0.00%)  1/40 (2.50%)  4/40 (10.00%)  1/40 (2.50%)  3/40 (7.50%) 
Productive cough  1  0/10 (0.00%)  0/10 (0.00%)  3/40 (7.50%)  2/40 (5.00%)  2/40 (5.00%)  3/40 (7.50%) 
Dyspnoea  1  0/10 (0.00%)  2/10 (20.00%)  1/40 (2.50%)  0/40 (0.00%)  1/40 (2.50%)  2/40 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00621322     History of Changes
Other Study ID Numbers: 110345
First Submitted: February 12, 2008
First Posted: February 22, 2008
Results First Submitted: December 8, 2016
Results First Posted: February 3, 2017
Last Update Posted: August 24, 2018