Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults
Official Title
Dose Range Study Evaluating Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccines (692342) When Administered to Healthy Adults Aged 18 to 45 Years.
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jul 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 3, 2008Actual
Primary Completion Date
Apr 3, 2009Actual
Completion Date
Apr 3, 2009Actual
First Submitted Date
Feb 12, 2008
First Submission Date that Met QC Criteria
Feb 21, 2008
First Posted Date
Feb 22, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 8, 2016
Results First Submitted that Met QC Criteria
Dec 8, 2016
Results First Posted Date
Feb 3, 2017Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 3, 2009
Certification/Extension First Submitted that Passed QC Review
Sep 3, 2009
Certification/Extension First Posted Date
Sep 4, 2009Estimated
Last Update Submitted Date
Jul 26, 2018
Last Update Posted Date
Aug 24, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
Not provided
Conditions Module
Conditions
Tuberculosis
Keywords
Tuberculosis vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
180Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Control Group
Placebo Comparator
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.
Biological: GSK Biologicals' AS01B adjuvant
GSK692342_F1 Group
Active Comparator
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK Biologicals' AS01B adjuvant
Biological
Intramuscular injection, 2 doses
Control Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Solicited Local Symptoms
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.
During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Number of Subjects With Solicited General Symptoms
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.
During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Number of Subjects With Unsolicited Adverse Events (AEs)
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.
During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
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.
Secondary Outcomes
Measure
Description
Time Frame
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Free of obvious health problems as established by medical history and clinical examination before enrolment into the study.
If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
No evidence of pulmonary pathology as confirmed by chest X-ray.
No history of extrapulmonary TB.
Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and urinalysis.
Seronegative for human immunodeficiency virus-1 and -2 (HIV-1 and -2) antibodies.
Subjects must have a PPD positive skin reactivity 48 to 72 hours after PPD skin test administration.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies and SSRIs.
History of previous administration of experimental Mycobacterium tuberculosis vaccines.
History of previous exposure to experimental products containing MPL or QS21.
Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
A family history (first generation) of congenital or hereditary immunodeficiency.
History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
History of any neurological disorders or seizures.
History of allergic reactions or anaphylaxis to previous immunisations.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of chronic alcohol consumption and/or drug abuse.
Major congenital defects.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
45 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Manila
1000
Philippines
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
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.
During the entire study period (from Day 0 up to Day 210)
Number of Subjects With Different Biochemical and Haematological Levels
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.
At Day 0
Number of Subjects With Different Biochemical and Haematological Levels
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.
At Day 7
Number of Subjects With Different Biochemical and Haematological Levels
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.
At Day 30
Number of Subjects With Different Biochemical and Haematological Levels
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.
At Day 37
Number of Subjects With Different Biochemical and Haematological Levels
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.
At Day 60
At Day 0, 30, 60 and 210
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
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.
At Day 0, 30, 60 and 210
Anti-M72 Specific Antibody Concentrations
Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).
At Day 0, 30, 60 and 210
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
FG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
FG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
FG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
FG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
FG00010 subjects
FG00110 subjects
FG00240 subjects
FG00340 subjects
FG00440 subjects
FG00540 subjects
COMPLETED
FG0009 subjects
FG00110 subjects
FG00238 subjects
FG00337 subjects
FG00439 subjects
FG00536 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG0041 subjects
FG0054 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Migrated/moved from study area
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
BG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
BG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
BG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
BG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
BG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG00110
BG00240
BG00340
BG00440
BG00540
BG006180
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00032.1± 8.10
BG00136.0± 5.14
BG00230.6± 9.14
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0017
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Subjects With Solicited Local Symptoms
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Posted
Number
Subjects
During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG003
Title
Denominators
Categories
Any Pain, Dose 1
Title
Measurements
OG0008
OG0013
OG00235
OG003
Primary
Number of Subjects With Solicited General Symptoms
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Posted
Number
Subjects
During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Primary
Number of Subjects With Unsolicited Adverse Events (AEs)
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Posted
Number
Subjects
During the 30-day (Days 0-29) post-vaccination period
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Primary
Number of Subjects With Serious Adverse Events (SAEs)
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Posted
Number
Subjects
During the entire study period (from Day 0 up to Day 210)
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Primary
Number of Subjects With Different Biochemical and Haematological Levels
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Posted
Number
Subjects
At Day 0
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG002
Primary
Number of Subjects With Different Biochemical and Haematological Levels
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Posted
Number
Subjects
At Day 7
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG002
Primary
Number of Subjects With Different Biochemical and Haematological Levels
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Posted
Number
Subjects
At Day 30
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG002
Primary
Number of Subjects With Different Biochemical and Haematological Levels
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Posted
Number
Subjects
At Day 37
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG002
Primary
Number of Subjects With Different Biochemical and Haematological Levels
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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
Posted
Number
Subjects
At Day 60
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG002
Secondary
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
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).
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.
Posted
Median
Inter-Quartile Range
T cells/million cells
At Day 0, 30, 60 and 210
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Secondary
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
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.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
Posted
Median
Inter-Quartile Range
T cells/million cells
At Day 0, 30, 60 and 210
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Secondary
Anti-M72 Specific Antibody Concentrations
Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL
At Day 0, 30, 60 and 210
ID
Title
Description
OG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
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
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Control Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
0
10
10
10
EG001
GSK692342_F1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
0
10
9
10
EG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
2
40
40
40
EG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
0
40
39
40
EG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
2
40
39
40
EG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
0
40
38
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected40 at risk
EG0030 affected40 at risk
EG0040 affected40 at risk
EG0050 affected40 at risk
Dengue fever
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected40 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected40 at risk
EG003
Typhoid fever
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected40 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected40 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected40 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain
General disorders
MedDRA
Systematic Assessment
EG0009 affected10 at risk
EG0015 affected10 at risk
EG00238 affected40 at risk
EG00337 affected40 at risk
EG00437 affected40 at risk
EG00536 affected40 at risk
Redness
General disorders
MedDRA
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected10 at risk
EG0027 affected40 at risk
EG003
Swelling
General disorders
MedDRA
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG00210 affected40 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected10 at risk
EG0027 affected40 at risk
EG003
Gastro-intestinal symptoms
General disorders
MedDRA
Systematic Assessment
EG0003 affected10 at risk
EG0013 affected10 at risk
EG0028 affected40 at risk
EG003
Headache
General disorders
MedDRA
Systematic Assessment
EG0005 affected10 at risk
EG0016 affected10 at risk
EG00225 affected40 at risk
EG003
Malaise
General disorders
MedDRA
Systematic Assessment
EG0005 affected10 at risk
EG0013 affected10 at risk
EG00223 affected40 at risk
EG003
Myalgia
General disorders
MedDRA
Systematic Assessment
EG0003 affected10 at risk
EG0013 affected10 at risk
EG00225 affected40 at risk
EG003
Temperature (Axillary)
General disorders
MedDRA
Systematic Assessment
EG0005 affected10 at risk
EG0011 affected10 at risk
EG00217 affected40 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0004 affected10 at risk
EG0015 affected10 at risk
EG00215 affected40 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0014 affected10 at risk
EG0023 affected40 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0002 affected10 at risk
EG0013 affected10 at risk
EG0025 affected40 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0001 affected10 at risk
EG0013 affected10 at risk
EG0024 affected40 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected10 at risk
EG0021 affected40 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected40 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0023 affected40 at risk
EG003
Feeling hot
General disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected40 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected10 at risk
EG0012 affected10 at risk
EG0021 affected40 at risk
EG003
Chills
General disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0023 affected40 at risk
EG003
Malaise
General disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0013 affected10 at risk
EG0020 affected40 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected10 at risk
EG0021 affected40 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected40 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected40 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected40 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D014376
Tuberculosis
Ancestor Terms
ID
Term
D009164
Mycobacterium Infections
D000193
Actinomycetales Infections
D016908
Gram-Positive Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0052 subjects
0 subjects
FG0052 subjects
33.5
± 8.73
BG00430.6± 9.17
BG00531.5± 8.83
BG00631.92± 8.67
33
BG00336
BG00431
BG00526
BG006142
Male
BG0001
BG0013
BG0027
BG0034
BG0049
BG00514
BG00638
40
OG00440
OG00540
33
OG00433
OG00532
Grade 3 Pain, Dose 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Any Redness, Dose 1
Title
Measurements
OG0001
OG0012
OG0027
OG0033
OG0044
OG0053
Grade 3 Redness, Dose 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Any Swelling, Dose 1
Title
Measurements
OG0000
OG0010
OG0028
OG0036
OG0047
OG0056
Grade 3 Swelling, Dose 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Any Pain, Dose 2
Title
Measurements
OG0007
OG0014
OG00233
OG00332
OG00436
OG00533
Grade 3 Pain, Dose 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Any Redness, Dose 2
Title
Measurements
OG0000
OG0011
OG0020
OG0035
OG0044
OG0055
Grade 3 Redness, Dose 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
Any Swelling, Dose 2
Title
Measurements
OG0001
OG0011
OG0025
OG0035
OG0047
OG0058
Grade 3 Swelling, Dose 2
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0051
Any Pain, Across
Title
Measurements
OG0009
OG0015
OG00238
OG00337
OG00437
OG00536
Grade 3 Pain, Across
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
Any Redness, Across
Title
Measurements
OG0001
OG0012
OG0027
OG0036
OG0046
OG0056
Grade 3 Redness, Across
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
Any Swelling, Across
Title
Measurements
OG0001
OG0011
OG00210
OG00310
OG00412
OG00512
Grade 3 Swelling, Across
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0052
OG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
Any Fatigue, Dose 1
Title
Measurements
OG0001
OG0011
OG0024
OG0035
OG0047
OG0053
Grade 3 Fatigue, Dose 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Fatigue, Dose 1
Title
Measurements
OG0000
OG0010
OG0021
OG003
Any Gastro, Dose 1
Title
Measurements
OG0002
OG0013
OG0025
OG003
Grade 3 Gastro, Dose 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Gastro, Dose 1
Title
Measurements
OG0002
OG0010
OG0023
OG003
Any Headache, Dose 1
Title
Measurements
OG0004
OG0014
OG00211
OG003
Grade 3 Headache, Dose 1
Title
Measurements
OG0001
OG0011
OG0020
OG003
Related Headache, Dose 1
Title
Measurements
OG0002
OG0010
OG0027
OG003
Any Malaise, Dose 1
Title
Measurements
OG0003
OG0013
OG0029
OG003
Grade 3 Malaise, Dose 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Malaise, Dose 1
Title
Measurements
OG0002
OG0010
OG0027
OG003
Any Myalgia, Dose 1
Title
Measurements
OG0001
OG0013
OG00214
OG003
Grade 3 Myalgia, Dose 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Myalgia, Dose 1
Title
Measurements
OG0001
OG0011
OG0029
OG003
Any Temperature, Dose 1
Title
Measurements
OG0002
OG0011
OG0023
OG003
Grade 3 Temperature, Dose 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Temperature, Dose 1
Title
Measurements
OG0001
OG0010
OG0023
OG003
Any Fatigue, Dose 2
Title
Measurements
OG0001
OG0011
OG0025
OG003
Grade 3 Fatigue, Dose 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Fatigue, Dose 2
Title
Measurements
OG0001
OG0011
OG0024
OG003
Any Gastro, Dose 2
Title
Measurements
OG0001
OG0011
OG0025
OG003
Grade 3 Gastro, Dose 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Gastro, Dose 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
Any Headache, Dose 2
Title
Measurements
OG0005
OG0013
OG00222
OG003
Grade 3 Headache, Dose 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
Related Headache, Dose 2
Title
Measurements
OG0001
OG0011
OG00213
OG003
Any Malaise, Dose 2
Title
Measurements
OG0005
OG0011
OG00222
OG003
Grade 3 Malaise, Dose 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
Related Malaise, Dose 2
Title
Measurements
OG0004
OG0011
OG00221
OG003
Any Myalgia, Dose 2
Title
Measurements
OG0003
OG0011
OG00218
OG003
Grade 3 Myalgia, Dose 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
Related Myalgia, Dose 2
Title
Measurements
OG0002
OG0011
OG00218
OG003
Any Temperature, Dose 2
Title
Measurements
OG0003
OG0010
OG00215
OG003
Grade 3 Temperature, Dose 2
Title
Measurements
OG0000
OG0010
OG0022
OG003
Related Temperature, Dose 2
Title
Measurements
OG0002
OG0010
OG00213
OG003
Any Fatigue, Across
Title
Measurements
OG0002
OG0011
OG0027
OG003
Grade 3 Fatigue, Across
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Fatigue, Across
Title
Measurements
OG0001
OG0011
OG0024
OG003
Any Gastro, Across
Title
Measurements
OG0003
OG0013
OG0028
OG003
Grade 3 Gastro, Across
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Gastro, Across
Title
Measurements
OG0002
OG0010
OG0024
OG003
Any Headache, Across
Title
Measurements
OG0005
OG0016
OG00225
OG003
Grade 3 Headache, Across
Title
Measurements
OG0001
OG0011
OG0021
OG003
Related Headache, Across
Title
Measurements
OG0003
OG0011
OG00218
OG003
Any Malaise, Across
Title
Measurements
OG0005
OG0013
OG00223
OG003
Grade 3 Malaise, Across
Title
Measurements
OG0000
OG0010
OG0021
OG003
Related Malaise, Across
Title
Measurements
OG0005
OG0011
OG00222
OG003
Any Myalgia, Across
Title
Measurements
OG0003
OG0013
OG00225
OG003
Grade 3 Myalgia, Across
Title
Measurements
OG0000
OG0010
OG0021
OG003
Related Myalgia, Across
Title
Measurements
OG0002
OG0012
OG00224
OG003
Any Temperature, Across
Title
Measurements
OG0005
OG0011
OG00217
OG003
Grade 3 Temperature, Across
Title
Measurements
OG0000
OG0010
OG0022
OG003
Related Temperature, Across
Title
Measurements
OG0003
OG0010
OG00215
OG003
OG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
Any AEs
Title
Measurements
OG0007
OG0019
OG00229
OG00333
OG00433
OG00527
Grade 3 AEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
Related AEs
Title
Measurements
OG0000
OG0011
OG0027
OG003
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0042
OG0050
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
ALT, Normal
Title
Measurements
OG00010
OG00110
OG00240
OG00338
OG00438
OG00537
ALT, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Missing
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Normal
Title
Measurements
OG0009
OG0019
OG00240
OG003
AST, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Above
Title
Measurements
OG0001
OG0011
OG0020
OG003
AST, Missing
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Normal
Title
Measurements
OG0003
OG00110
OG00211
OG003
BAS, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Missing
Title
Measurements
OG0007
OG0010
OG00229
OG003
CREA, Normal
Title
Measurements
OG0009
OG00110
OG00238
OG003
CREA, Below
Title
Measurements
OG0001
OG0010
OG0022
OG003
CREA, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
CREA, Missing
Title
Measurements
OG0000
OG0010
OG0020
OG003
EOS, Normal
Title
Measurements
OG0009
OG0018
OG00238
OG003
EOS, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
EOS, Above
Title
Measurements
OG0001
OG0012
OG0020
OG003
EOS, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hct, Normal
Title
Measurements
OG00010
OG0019
OG00238
OG003
Hct, Below
Title
Measurements
OG0000
OG0011
OG0021
OG003
Hct, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hct, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hgb, Normal
Title
Measurements
OG00010
OG0018
OG00239
OG003
Hgb, Below
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hgb, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hgb, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
LYM, Normal
Title
Measurements
OG0009
OG00110
OG00238
OG003
LYM, Below
Title
Measurements
OG0001
OG0010
OG0021
OG003
LYM, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
LYM, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
MON, Normal
Title
Measurements
OG00010
OG0019
OG00239
OG003
MON, Below
Title
Measurements
OG0000
OG0011
OG0020
OG003
MON, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
MON, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
NEU, Normal
Title
Measurements
OG0009
OG00110
OG00235
OG003
NEU, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
NEU, Above
Title
Measurements
OG0001
OG0010
OG0024
OG003
NEU, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
PLA, Normal
Title
Measurements
OG00010
OG00110
OG00239
OG003
PLA, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
PLA, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
PLA, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
RBC, Normal
Title
Measurements
OG0009
OG0017
OG00236
OG003
RBC, Below
Title
Measurements
OG0001
OG0011
OG0022
OG003
RBC, Above
Title
Measurements
OG0000
OG0012
OG0021
OG003
RBC, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
WBC, Normal
Title
Measurements
OG00010
OG0019
OG00237
OG003
WBC, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC, Above
Title
Measurements
OG0000
OG0011
OG0022
OG003
WBC, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
ALT, Normal
Title
Measurements
OG00010
OG00110
OG00236
OG00332
OG00438
OG00534
ALT, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
ALT, Above
Title
Measurements
OG0000
OG0010
OG0022
OG003
ALT, Missing
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Normal
Title
Measurements
OG00010
OG00110
OG00239
OG003
AST, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
BAS, Normal
Title
Measurements
OG0002
OG00110
OG0021
OG003
BAS, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Missing
Title
Measurements
OG0008
OG0010
OG00239
OG003
CREA, Normal
Title
Measurements
OG00010
OG00110
OG00238
OG003
CREA, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
CREA, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
CREA, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
EOS, Normal
Title
Measurements
OG00010
OG0016
OG00238
OG003
EOS, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
EOS, Above
Title
Measurements
OG0000
OG0014
OG0021
OG003
EOS, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hct, Normal
Title
Measurements
OG00010
OG0018
OG00237
OG003
Hct, Below
Title
Measurements
OG0000
OG0012
OG0022
OG003
Hct, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hct, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hgb, Normal
Title
Measurements
OG00010
OG0017
OG00239
OG003
Hgb, Below
Title
Measurements
OG0000
OG0013
OG0020
OG003
Hgb, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hgb, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
LYM, Normal
Title
Measurements
OG00010
OG00110
OG00238
OG003
LYM, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
LYM, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
LYM, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
MON, Normal
Title
Measurements
OG00010
OG0019
OG00239
OG003
MON, Below
Title
Measurements
OG0000
OG0011
OG0020
OG003
MON, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
MON, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
NEU, Normal
Title
Measurements
OG0009
OG00110
OG00238
OG003
NEU, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
NEU, Above
Title
Measurements
OG0001
OG0010
OG0021
OG003
NEU, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
PLA, Normal
Title
Measurements
OG00010
OG0019
OG00239
OG003
PLA, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
PLA, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
PLA, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
RBC, Normal
Title
Measurements
OG0008
OG0018
OG00233
OG003
RBC, Below
Title
Measurements
OG0002
OG0011
OG0025
OG003
RBC, Above
Title
Measurements
OG0000
OG0011
OG0021
OG003
RBC, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
WBC, Normal
Title
Measurements
OG0009
OG0019
OG00233
OG003
WBC, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC, Above
Title
Measurements
OG0001
OG0011
OG0026
OG003
WBC, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
ALT, Normal
Title
Measurements
OG0009
OG0019
OG00238
OG00336
OG00436
OG00538
ALT, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Above
Title
Measurements
OG0001
OG0011
OG0021
OG003
ALT, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
AST, Normal
Title
Measurements
OG00010
OG00110
OG00238
OG003
AST, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
AST, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
BAS, Normal
Title
Measurements
OG0004
OG00110
OG0025
OG003
BAS, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Missing
Title
Measurements
OG0006
OG0010
OG00235
OG003
CREA, Normal
Title
Measurements
OG00010
OG0019
OG00239
OG003
CREA, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
CREA, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
CREA, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
EOS, Normal
Title
Measurements
OG0008
OG0018
OG00237
OG003
EOS, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
EOS, Above
Title
Measurements
OG0001
OG0012
OG0021
OG003
EOS, Missing
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hct, Normal
Title
Measurements
OG0008
OG0017
OG00236
OG003
Hct, Below
Title
Measurements
OG0001
OG0013
OG0023
OG003
Hct, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hct, Missing
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hgb, Normal
Title
Measurements
OG0008
OG0017
OG00238
OG003
Hgb, Below
Title
Measurements
OG0001
OG0013
OG0021
OG003
Hgb, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hgb, Missing
Title
Measurements
OG0001
OG0010
OG0021
OG003
LYM, Normal
Title
Measurements
OG0009
OG0019
OG00238
OG003
LYM, Below
Title
Measurements
OG0000
OG0011
OG0021
OG003
LYM, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
LYM, Missing
Title
Measurements
OG0001
OG0010
OG0021
OG003
MON, Normal
Title
Measurements
OG0009
OG00110
OG00239
OG003
MON, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
MON, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
MON, Missing
Title
Measurements
OG0001
OG0010
OG0021
OG003
NEU, Normal
Title
Measurements
OG0009
OG00110
OG00238
OG003
NEU, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
NEU, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
NEU, Missing
Title
Measurements
OG0001
OG0010
OG0021
OG003
PLA, Normal
Title
Measurements
OG0009
OG00110
OG00239
OG003
PLA, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
PLA, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
PLA, Missing
Title
Measurements
OG0001
OG0010
OG0021
OG003
RBC, Normal
Title
Measurements
OG0009
OG0018
OG00236
OG003
RBC, Below
Title
Measurements
OG0000
OG0011
OG0022
OG003
RBC, Above
Title
Measurements
OG0000
OG0011
OG0021
OG003
RBC, Missing
Title
Measurements
OG0001
OG0010
OG0021
OG003
WBC, Normal
Title
Measurements
OG0009
OG0018
OG00235
OG003
WBC, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC, Above
Title
Measurements
OG0000
OG0012
OG0024
OG003
WBC, Missing
Title
Measurements
OG0001
OG0010
OG0021
OG003
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
ALT, Normal
Title
Measurements
OG0009
OG00110
OG00237
OG00336
OG00434
OG00535
ALT, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Above
Title
Measurements
OG0001
OG0010
OG0022
OG003
ALT, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
AST, Normal
Title
Measurements
OG00010
OG00110
OG00237
OG003
AST, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Above
Title
Measurements
OG0000
OG0010
OG0022
OG003
AST, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
BAS, Normal
Title
Measurements
OG0004
OG00110
OG00210
OG003
BAS, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Missing
Title
Measurements
OG0006
OG0010
OG0020
OG003
CREA, Normal
Title
Measurements
OG00010
OG0019
OG00238
OG003
CREA, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
CREA, Below
Title
Measurements
OG0000
OG0011
OG0021
OG003
CREA, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
EOS, Normal
Title
Measurements
OG0006
OG0017
OG00235
OG003
EOS, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
EOS, Above
Title
Measurements
OG0004
OG0013
OG0023
OG003
EOS, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hct, Normal
Title
Measurements
OG0008
OG0017
OG00234
OG003
Hct, Below
Title
Measurements
OG0002
OG0013
OG0025
OG003
Hct, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hct, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hgb, Normal
Title
Measurements
OG0009
OG0016
OG00236
OG003
Hgb, Below
Title
Measurements
OG0001
OG0014
OG0023
OG003
Hgb, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hgb, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
LYM, Normal
Title
Measurements
OG00010
OG00110
OG00238
OG003
LYM, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
LYM, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
LYM, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
MON, Normal
Title
Measurements
OG00010
OG00110
OG00239
OG003
MON, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
MON, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
MON, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
NEU, Normal
Title
Measurements
OG00010
OG00110
OG00238
OG003
NEU, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
NEU, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
NEU, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
PLA, Normal
Title
Measurements
OG00010
OG0019
OG00237
OG003
PLA, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
PLA, Above
Title
Measurements
OG0000
OG0011
OG0022
OG003
PLA, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
RBC, Normal
Title
Measurements
OG0009
OG0018
OG00234
OG003
RBC, Below
Title
Measurements
OG0001
OG0011
OG0025
OG003
RBC, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
RBC, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
WBC, Normal
Title
Measurements
OG0009
OG0017
OG00232
OG003
WBC, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC, Above
Title
Measurements
OG0001
OG0013
OG0027
OG003
WBC, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
ALT, Normal
Title
Measurements
OG0009
OG0019
OG00238
OG00337
OG00438
OG00534
ALT, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Above
Title
Measurements
OG0001
OG0011
OG0021
OG003
ALT, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
AST, Normal
Title
Measurements
OG0009
OG0019
OG00238
OG003
AST, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Above
Title
Measurements
OG0001
OG0011
OG0021
OG003
AST, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
BAS, Normal
Title
Measurements
OG00010
OG00110
OG00238
OG003
BAS, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
BAS, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
CREA, Normal
Title
Measurements
OG00010
OG0019
OG00238
OG003
CREA, Below
Title
Measurements
OG0000
OG0011
OG0021
OG003
CREA, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
CREA, Missing
Title
Measurements
OG0000
OG0010
OG0021
OG003
EOS, Normal
Title
Measurements
OG0007
OG0017
OG00234
OG003
EOS, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
EOS, Above
Title
Measurements
OG0003
OG0013
OG0024
OG003
EOS, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
Hct, Normal
Title
Measurements
OG0009
OG0018
OG00233
OG003
Hct, Below
Title
Measurements
OG0001
OG0012
OG0025
OG003
Hct, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hct, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
Hgb, Normal
Title
Measurements
OG0009
OG0018
OG00235
OG003
Hgb, Below
Title
Measurements
OG0001
OG0012
OG0023
OG003
Hgb, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hgb, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
LYM, Normal
Title
Measurements
OG00010
OG0018
OG00238
OG003
LYM, Below
Title
Measurements
OG0000
OG0012
OG0020
OG003
LYM, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
LYM, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
MON, Normal
Title
Measurements
OG00010
OG0019
OG00237
OG003
MON, Below
Title
Measurements
OG0000
OG0011
OG0021
OG003
MON, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
MON, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
NEU, Normal
Title
Measurements
OG0009
OG0018
OG00238
OG003
NEU, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
NEU, Above
Title
Measurements
OG0001
OG0012
OG0020
OG003
NEU, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
PLA, Normal
Title
Measurements
OG00010
OG0019
OG00238
OG003
PLA, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
PLA, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
PLA, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
RBC, Normal
Title
Measurements
OG0009
OG0018
OG00236
OG003
RBC, Below
Title
Measurements
OG0001
OG0011
OG0022
OG003
RBC, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
RBC, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
WBC, Normal
Title
Measurements
OG0008
OG0017
OG00234
OG003
WBC, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC, Above
Title
Measurements
OG0002
OG0013
OG0024
OG003
WBC, Missing
Title
Measurements
OG0000
OG0010
OG0022
OG003
OG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
CD4-All Doubles, D0 [N=9;9;38;34;40;39]
Title
Measurements
OG000173.0(94.0 to 466.0)
OG001293.0(213.0 to 853.0)
OG002200.0(87.0 to 537.0)
OG003241.0(147.0 to 547.0)
OG004263.5(80.5 to 528.5)
OG005312.0(133.0 to 488.0)
CD4-All Doubles, D30 [N=10;10;38;36;39;37]
Title
Measurements
OG000245.5(80.0 to 387.0)
OG0011013.5(491.0 to 3227.0)
OG0022833.0(1440.0 to 5120.0)
OG003
CD4-All Doubles, D60 [N=10;9;38;36;38;37]
Title
Measurements
OG000139.5(27.0 to 187.0)
OG0012133.0(640.0 to 3240.0)
OG0026307.0(3560.0 to 9307.0)
OG003
CD4-All Doubles, D210 [N=9;7;37;32;35;34]
Title
Measurements
OG000106.0(91.0 to 414.0)
OG0011426.0(949.0 to 2814.0)
OG0023826.0(2467.0 to 5907.0)
OG003
CD8-All Doubles, D0 [N=9;9;38;34;40;39]
Title
Measurements
OG0001.0(1.0 to 65.0)
OG0015.0(1.0 to 35.0)
OG00217.0(1.0 to 104.0)
OG003
CD8-All Doubles, D30 [N=10;10;38;36;39;37]
Title
Measurements
OG00031.0(1.0 to 46.0)
OG00120.5(1.0 to 146.0)
OG00239.5(1.0 to 102.0)
OG003
CD8-All Doubles, D60 [N=10;9;38;36;38;37]
Title
Measurements
OG0009.5(1.0 to 175.0)
OG00116.0(1.0 to 33.0)
OG0021.0(1.0 to 71.0)
OG003
CD8-All Doubles, D210 [N=9;7;37;32;35;34]
Title
Measurements
OG0001.0(1.0 to 179.0)
OG0011.0(1.0 to 28.0)
OG0021.0(1.0 to 35.0)
OG003
OG002
GSK692342_F2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
Units
Counts
Participants
OG00010
OG00110
OG00240
OG00340
OG00440
OG00540
Title
Denominators
Categories
CD4-CD40-L, D0 [N=9;9;38;34;40;39]
Title
Measurements
OG000104.0(66.0 to 306.0)
OG001227.0(186.0 to 840.0)
OG002147.0(41.0 to 254.0)
OG003151.0(107.0 to 320.0)
OG004210.5(73.0 to 388.0)
OG005261.0(94.0 to 418.0)
CD4-CD40-L, D30 [N=10;10;38;36;39;37]
Title
Measurements
OG000188.0(40.0 to 307.0)
OG001853.0(427.0 to 3133.0)
OG0021934.0(1333.0 to 3600.0)
OG003
CD4-CD40-L, D60 [N=10;9;38;36;38;37]
Title
Measurements
OG00087.0(1.0 to 227.0)
OG0011986.0(560.0 to 3173.0)
OG0025413.5(2535.0 to 7235.0)
OG003
CD4-CD40-L, D210 [N=9;7;37;32;35;34]
Title
Measurements
OG000120.0(80.0 to 380.0)
OG0011374.0(920.0 to 2693.0)
OG0023727.0(2431.0 to 5733.0)
OG003
CD40-IL-2, D0 [N=9;9;38;34;40;39]
Title
Measurements
OG000146.0(93.0 to 467.0)
OG001333.0(207.0 to 787.0)
OG002173.0(66.0 to 373.0)
OG003
CD4-IL-2, D30 [N=10;10;38;36;39;37]
Title
Measurements
OG000218.5(40.0 to 320.0)
OG0011046.5(453.0 to 2356.0)
OG0022560.0(1426.0 to 4680.0)
OG003
CD4-IL-2, D60 [N=10;9;38;36;38;37]
Title
Measurements
OG000107.0(34.0 to 200.0)
OG0011773.0(533.0 to 2840.0)
OG0025704.0(3284.0 to 7947.0)
OG003
CD4-IL-2, D210 [N=9;7;37;32;35;34]
Title
Measurements
OG000114.0(66.0 to 312.0)
OG0011427.0(840.0 to 2227.0)
OG0023240.0(2360.0 to 5813.0)
OG003
CD40-TNF-α, D0 [N=9;9;38;34;40;39]
Title
Measurements
OG00078.0(53.0 to 334.0)
OG001220.0(146.0 to 640.0)
OG002143.5(67.0 to 493.0)
OG003
CD4-TNF-α, D30 [N=10;10;38;36;39;37]
Title
Measurements
OG000185.5(93.0 to 346.0)
OG001733.5(345.0 to 2360.0)
OG0022028.0(1013.0 to 4080.0)
OG003
CD4-TNF-α, D60 [N=10;9;38;36;38;37]
Title
Measurements
OG00073.0(1.0 to 226.0)
OG001907.0(427.0 to 1373.0)
OG0023993.5(1788.0 to 7223.0)
OG003
CD4-TNF-α, D210 [N=9;7;37;32;35;34]
Title
Measurements
OG00072.0(1.0 to 379.0)
OG0011106.0(718.0 to 2307.0)
OG0022960.0(1613.0 to 4987.0)
OG003
CD40-IFN-γ, D0 [N=9;9;38;34;40;39]
Title
Measurements
OG000134.0(13.0 to 480.0)
OG001258.0(214.0 to 840.0)
OG002180.5(67.0 to 471.0)
OG003
CD4-IFN-γ, D30 [N=10;10;38;36;39;37]
Title
Measurements
OG000206.5(54.0 to 279.0)
OG001626.5(333.0 to 2306.0)
OG0021477.0(496.0 to 3675.0)
OG003
CD4-IFN-γ, D60 [N=10;9;38;36;38;37]
Title
Measurements
OG000111.0(40.0 to 266.0)
OG0011014.0(320.0 to 1480.0)
OG0023070.5(1134.0 to 4794.0)
OG003
CD4-IFN-γ, D210 [N=9;7;37;32;35;34]
Title
Measurements
OG000146.0(107.0 to 360.0)
OG001933.0(336.0 to 1826.0)
OG0021907.0(827.0 to 3413.0)
OG003
OG003
GSK692342_F3 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG004
GSK692342_F4D1 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
OG005
GSK692342_F4D2 Group
Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.