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Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342

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ClinicalTrials.gov Identifier: NCT01669096
Recruitment Status : Completed
First Posted : August 20, 2012
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Aeras
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Tuberculosis
Intervention Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
33.7  (11.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
13
  65.0%
Male
7
  35.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
African/African American heritage
10
  50.0%
White-Caucasian/European heritage
9
  45.0%
Asian-East Asian heritage
1
   5.0%
1.Primary Outcome
Title Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples
Hide Description Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
Time Frame At Day 0 prior to Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: fg/mL
6279.7
(4624.2 to 8527.7)
2.Primary Outcome
Title Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples
Hide Description Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
Time Frame At Day 30 post-Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: fg/mL
7035.1
(5089.0 to 9725.5)
3.Primary Outcome
Title Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples
Hide Description Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
Time Frame At Day 31 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: fg/mL
64288.5
(33671.9 to 122743.5)
4.Primary Outcome
Title Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples
Hide Description Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
Time Frame At Day 37 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: fg/mL
32710.5
(23747.1 to 45057.0)
5.Primary Outcome
Title Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples
Hide Description Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
Time Frame At Day 40 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: fg/mL
8851.2
(5250.8 to 14920.4)
6.Primary Outcome
Title Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples
Hide Description Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
Time Frame At Day 44 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: fg/mL
6755.1
(4939.5 to 9238.0)
7.Primary Outcome
Title Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples
Hide Description Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
Time Frame At Day 47 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: fg/mL
7245.0
(5389.6 to 9739.3)
8.Primary Outcome
Title Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers
Hide Description Among immune markers expressed were interleukin-2 (IL-2) and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ) and/or cluster of differentiation 40-ligand (CD40-L) and/or IL-13 and/or IL-17. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).
Time Frame At Day 0 prior to Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
CD4+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13
97.0
(1.0 to 224.0)
CD8+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13
95.0
(2.0 to 230.0)
9.Primary Outcome
Title Frequency of M72 Fusion Protein Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers
Hide Description Among immune markers expressed were interleukin-2 (IL-2) and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ) and/or cluster of differentiation 40-ligand [CD40-L] and/or IL-13 and/or IL-17. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).
Time Frame At Day 60 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
CD4+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13
5200.0
(485.0 to 15302.0)
CD8+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13
134.0
(54.0 to 635.5)
10.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14)
Hide Description Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M2=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M3=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M4=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M5=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M6=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M7=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M8=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M9=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M10=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M11=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M12=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M13=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M14=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-).
Time Frame At Day 0 prior -Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M1
1.0
(1.0 to 1.0)
M2
1.0
(1.0 to 26.0)
M3
1.0
(1.0 to 1.0)
M4
96.0
(43.0 to 115.0)
M5
1.0
(1.0 to 1.0)
M6
1.0
(1.0 to 14.0)
M7
1.0
(1.0 to 1.0)
M8
1.0
(1.0 to 14.0)
M9
1.0
(1.0 to 1.0)
M10
1.0
(1.0 to 1.0)
M11
1.0
(1.0 to 1.0)
M12
1.0
(1.0 to 13.0)
M13
1.0
(1.0 to 1.0)
M14
14.0
(1.0 to 17.0)
11.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28)
Hide Description Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M16=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M17=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M18=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M19=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M20=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M21=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M22=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M23=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M24=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M25=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M26=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M27=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M28=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-).
Time Frame At Day 0 prior-Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M15
1.0
(1.0 to 1.0)
M16
15.0
(1.0 to 42.0)
M17
1.0
(1.0 to 1.0)
M18
1.0
(1.0 to 1.0)
M19
1.0
(1.0 to 1.0)
M20
13.0
(1.0 to 14.0)
M21
1.0
(1.0 to 1.0)
M22
1.0
(1.0 to 14.0)
M23
1.0
(1.0 to 1.0)
M24
1.0
(1.0 to 43.0)
M25
1.0
(1.0 to 1.0)
M26
1.0
(1.0 to 1.0)
M27
1.0
(1.0 to 1.0)
M28
1.0
(1.0 to 14.0)
12.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42)
Hide Description Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M30=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M31=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M32=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M33=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M34=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M35=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M36=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M37=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M38=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M39=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M40=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M41=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M42=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).
Time Frame At Day 0 prior - Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M29
1.0
(1.0 to 1.0)
M30
1.0
(1.0 to 1.0)
M31
1.0
(1.0 to 1.0)
M32
1.0
(1.0 to 227.0)
M33
1.0
(1.0 to 1.0)
M34
1.0
(1.0 to 1.0)
M35
1.0
(1.0 to 1.0)
M36
1.0
(1.0 to 17.0)
M37
1.0
(1.0 to 1.0)
M38
1.0
(1.0 to 14.0)
M39
1.0
(1.0 to 1.0)
M40
1.0
(1.0 to 14.0)
M41
1.0
(1.0 to 1.0)
M42
1.0
(1.0 to 1.0)
13.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56)
Hide Description Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M44=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M45=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M46=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M47=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M48=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M49=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M50=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M51=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M52=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M53=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M54=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M55=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M56=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-).
Time Frame At Day 0 (prior- Dose 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M43
1.0
(1.0 to 14.0)
M44
1.0
(1.0 to 1.0)
M45
1.0
(1.0 to 14.0)
M46
1.0
(1.0 to 1.0)
M47
1.0
(1.0 to 1.0)
M48
1.0
(1.0 to 1.0)
M49
1.0
(1.0 to 1.0)
M50
1.0
(1.0 to 13.0)
M51
1.0
(1.0 to 1.0)
M52
1.0
(1.0 to 28.0)
M53
1.0
(1.0 to 1.0)
M54
1.0
(1.0 to 13.0)
M55
1.0
(1.0 to 1.0)
M56
48.0
(1.0 to 90.0)
14.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63)
Hide Description Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M58=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M59=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M60=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M61=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M62=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M63=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+).
Time Frame At Day 0 (prior to Dose 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M57
1.0
(1.0 to 1.0)
M58
1.0
(1.0 to 1.0)
M59
1.0
(1.0 to 1.0)
M60
28.0
(6.0 to 56.0)
M61
1.0
(1.0 to 1.0)
M62
13.0
(1.0 to 16.0)
M63
1.0
(1.0 to 25.0)
15.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14)
Hide Description Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M2=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M3=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M4=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M5=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M6=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M7=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M8=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M9=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M10=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M11=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M12=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M13=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M14=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-).
Time Frame At Day 60 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M1
1.0
(1.0 to 1.0)
M2
14.0
(1.0 to 28.5)
M3
21.5
(7.5 to 28.5)
M4
990.0
(517.5 to 1344.5)
M5
1.0
(1.0 to 1.0)
M6
7.5
(1.0 to 24.0)
M7
28.5
(13.5 to 152.0)
M8
1830.5
(1084.5 to 3845.5)
M9
1.0
(1.0 to 1.0)
M10
1.0
(1.0 to 1.0)
M11
1.0
(1.0 to 7.5)
M12
142.5
(86.0 to 228.0)
M13
1.0
(1.0 to 1.5)
M14
1.0
(1.0 to 13.5)
16.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28)
Hide Description Expressed immune markers combinations for CD4+/CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M16=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M17=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M18=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M19=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M20=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M21=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M22=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M23=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M24=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M25=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M26=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M27=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M28=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-).
Time Frame At Day 60 post - Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M15
7.0
(1.0 to 55.5)
M16
1202.5
(561.5 to 1827.5)
M17
1.0
(1.0 to 1.0)
M18
1.0
(1.0 to 1.0)
M19
1.0
(1.0 to 15.5)
M20
300.0
(94.5 to 529.5)
M21
1.0
(1.0 to 1.0)
M22
18.5
(13.5 to 28.0)
M23
1.0
(1.0 to 28.0)
M24
666.5
(230.5 to 1220.5)
M25
1.0
(1.0 to 1.0)
M26
1.0
(1.0 to 1.0)
M27
1.0
(1.0 to 1.0)
M28
87.0
(40.5 to 179.5)
17.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42)
Hide Description Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M30=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M31=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M32=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M33=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M34=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M35=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M36=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M37=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M38=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M39=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M40=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M41=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M42=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).
Time Frame At Day 60 post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M29
1.0
(1.0 to 1.0)
M30
1.0
(1.0 to 14.0)
M31
1.0
(1.0 to 22.5)
M32
1198.5
(80.5 to 2845.5)
M33
1.0
(1.0 to 1.0)
M34
1.0
(1.0 to 1.0)
M35
1.0
(1.0 to 1.0)
M36
28.0
(1.0 to 78.0)
M37
1.0
(1.0 to 1.0)
M38
1.0
(1.0 to 7.5)
M39
1.0
(1.0 to 1.0)
M40
69.0
(20.0 to 225.5)
M41
1.0
(1.0 to 1.0)
M42
1.0
(1.0 to 1.0)
18.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56)
Hide Description Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M44=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M45=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M46=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M47=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M48=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M49=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M50=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M51=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M52=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M53=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M54=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M55=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M56=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-).
Time Frame At Day 60 (post-Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M43
1.0
(1.0 to 14.0)
M44
1.0
(1.0 to 1.0)
M45
13.5
(1.0 to 18.0)
M46
1.0
(1.0 to 7.5)
M47
66.0
(1.0 to 121.0)
M48
1.0
(1.0 to 1.0)
M49
1.0
(1.0 to 1.0)
M50
1.0
(1.0 to 1.0)
M51
1.0
(1.0 to 1.0)
M52
55.5
(29.0 to 184.0)
M53
1.0
(1.0 to 1.0)
M54
28.0
(7.0 to 36.0)
M55
1.0
(1.0 to 1.0)
M56
163.0
(75.5 to 383.0)
19.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63)
Hide Description Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M58=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M59=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M60=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M61=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M62=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M63=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+).
Time Frame At Day 60 post- Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M57
1.0
(1.0 to 1.0)
M58
1.0
(1.0 to 13.5)
M59
1.0
(1.0 to 7.5)
M60
15.0
(1.0 to 145.5)
M61
1.0
(1.0 to 1.0)
M62
20.5
(1.0 to 34.0)
M63
1.0
(1.0 to 50.0)
20.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M2=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M3=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M4=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M5=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M6=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M7=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M8=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M9=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M10=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M11=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M12=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M13=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M14=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).
Time Frame At Day 0 prior-Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M1
1.0
(1.0 to 1.0)
M2
1.0
(1.0 to 1.0)
M3
1.0
(1.0 to 23.0)
M4
1.0
(1.0 to 1.0)
M5
1.0
(1.0 to 1.0)
M6
1.0
(1.0 to 1.0)
M7
1.0
(1.0 to 1.0)
M8
1.0
(1.0 to 1.0)
M9
1.0
(1.0 to 1.0)
M10
1.0
(1.0 to 1.0)
M11
1.0
(1.0 to 1.0)
M12
1.0
(1.0 to 1.0)
M13
1.0
(1.0 to 1.0)
M14
1.0
(1.0 to 1.0)
21.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M16=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M17=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M18=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M19=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M20=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M21=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M22=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M23=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M24=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M25=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M26=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M27=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M28=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+).
Time Frame At Day 0 prior -Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M15
1.0
(1.0 to 1.0)
M16
1.0
(1.0 to 1.0)
M17
1.0
(1.0 to 1.0)
M18
1.0
(1.0 to 1.0)
M19
6.0
(1.0 to 128.0)
M20
1.0
(1.0 to 1.0)
M21
1.0
(1.0 to 1.0)
M22
1.0
(1.0 to 1.0)
M23
1.0
(1.0 to 1.0)
M24
1.0
(1.0 to 1.0)
M25
1.0
(1.0 to 1.0)
M26
1.0
(1.0 to 1.0)
M27
1.0
(1.0 to 1.0)
M28
1.0
(1.0 to 1.0)
22.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M30=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M31=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M32=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M33=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M34=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M35=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M36=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M37=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M38=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M39=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M40=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M41=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M42=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+).
Time Frame At Day 0 prior- Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M29
1.0
(1.0 to 1.0)
M30
1.0
(1.0 to 1.0)
M31
1.0
(1.0 to 1.0)
M32
1.0
(1.0 to 1.0)
M33
1.0
(1.0 to 1.0)
M34
1.0
(1.0 to 1.0)
M35
1.0
(1.0 to 62.0)
M36
1.0
(1.0 to 1.0)
M37
1.0
(1.0 to 1.0)
M38
1.0
(1.0 to 1.0)
M39
32.0
(3.0 to 160.0)
M40
1.0
(1.0 to 1.0)
M41
1.0
(1.0 to 1.0)
M42
1.0
(1.0 to 1.0)
23.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M44=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M45=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M46=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M47=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M48=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M49=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M50=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M51=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M52=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M53=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M54=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M55=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M56=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-).
Time Frame At Day 0 prior to Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M43
38.0
(4.0 to 69.0)
M44
1.0
(1.0 to 1.0)
M45
1.0
(1.0 to 1.0)
M46
1.0
(1.0 to 1.0)
M47
66.0
(1.0 to 333.0)
M48
1.0
(1.0 to 1.0)
M49
1.0
(1.0 to 31.0)
M50
1.0
(1.0 to 101.0)
M51
1.0
(1.0 to 1.0)
M52
1.0
(1.0 to 1.0)
M53
1.0
(1.0 to 1.0)
M54
1.0
(1.0 to 1.0)
M55
1.0
(1.0 to 1.0)
M56
1.0
(1.0 to 1.0)
24.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M58=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M59=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M60=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M61=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M62=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M63=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+).
Time Frame At Day 0 (prior to Dose 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M57
1.0
(1.0 to 1.0)
M58
1.0
(1.0 to 1.0)
M59
1.0
(1.0 to 1.0)
M60
1.0
(1.0 to 1.0)
M61
1.0
(1.0 to 1.0)
M62
1.0
(1.0 to 1.0)
M63
1.0
(1.0 to 1.0)
25.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M2=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M3=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M4=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M5=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M6=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M7=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M8=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M9=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M10=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M11=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M12=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M13=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M14=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).
Time Frame At Day 60 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M1
1.0
(1.0 to 1.0)
M2
1.0
(1.0 to 1.0)
M3
1.0
(1.0 to 42.0)
M4
1.0
(1.0 to 1.0)
M5
1.0
(1.0 to 1.0)
M6
1.0
(1.0 to 1.0)
M7
1.0
(1.0 to 10.0)
M8
1.0
(1.0 to 1.0)
M9
1.0
(1.0 to 1.0)
M10
1.0
(1.0 to 1.0)
M11
1.0
(1.0 to 1.0)
M12
1.0
(1.0 to 1.0)
M13
1.0
(1.0 to 1.0)
M14
1.0
(1.0 to 1.0)
26.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M16=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M17=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M18=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M19=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M20=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M21=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M22=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M23=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M24=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M25=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M26=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M27=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M28=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+).
Time Frame At Day 60 post -Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M15
1.0
(1.0 to 1.0)
M16
1.0
(1.0 to 1.0)
M17
1.0
(1.0 to 1.0)
M18
1.0
(1.0 to 1.0)
M19
1.0
(1.0 to 43.5)
M20
1.0
(1.0 to 1.0)
M21
1.0
(1.0 to 1.0)
M22
1.0
(1.0 to 1.0)
M23
1.0
(1.0 to 22.5)
M24
1.0
(1.0 to 1.0)
M25
1.0
(1.0 to 1.0)
M26
1.0
(1.0 to 1.0)
M27
1.0
(1.0 to 1.0)
M28
1.0
(1.0 to 1.0)
27.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M30=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M31=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M32=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M33=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M34=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M35=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M36=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M37=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M38=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M39=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M40=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M41=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M42=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+).
Time Frame At Day 60 post- Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M29
1.0
(1.0 to 1.0)
M30
1.0
(1.0 to 1.0)
M31
1.0
(1.0 to 61.5)
M32
1.0
(1.0 to 1.0)
M33
1.0
(1.0 to 1.0)
M34
1.0
(1.0 to 1.0)
M35
14.5
(1.0 to 110.5)
M36
1.0
(1.0 to 1.0)
M37
1.0
(1.0 to 1.0)
M38
1.0
(1.0 to 1.0)
M39
40.5
(1.0 to 339.5)
M40
1.0
(1.0 to 1.0)
M41
1.0
(1.0 to 1.0)
M42
1.0
(1.0 to 1.0)
28.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M44=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M45=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M46=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M47=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M48=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M49=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M50=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M51=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M52=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M53=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M54=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M55=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M56=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-).
Time Frame At Day 60 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M43
10.0
(1.0 to 189.5)
M44
1.0
(1.0 to 1.0)
M45
1.0
(1.0 to 1.0)
M46
1.0
(1.0 to 1.0)
M47
109.0
(1.0 to 1432.5)
M48
1.0
(1.0 to 1.0)
M49
1.0
(1.0 to 13.0)
M50
13.5
(1.0 to 64.5)
M51
1.0
(1.0 to 1.0)
M52
1.0
(1.0 to 1.0)
M53
1.0
(1.0 to 1.0)
M54
45.0
(1.0 to 57.5)
M55
1.0
(1.0 to 1.0)
M56
1.0
(1.0 to 1.0)
29.Primary Outcome
Title Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63)
Hide Description Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M58=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M59=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M60=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M61=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M62=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M63=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+).
Time Frame At Day 60 post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
M57
1.0
(1.0 to 1.0)
M58
1.0
(1.0 to 1.0)
M59
1.0
(1.0 to 1.0)
M60
1.0
(1.0 to 1.0)
M61
1.0
(1.0 to 1.0)
M62
1.0
(1.0 to 1.0)
M63
1.0
(1.0 to 1.0)
30.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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 to Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
31.Primary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
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 subjects with at least one vaccine administration documented.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 20 participants
18
  90.0%
Grade 3 Pain, Dose 1 Number Analyzed 20 participants
3
  15.0%
Any Redness, Dose 1 Number Analyzed 20 participants
4
  20.0%
Grade 3 Redness, Dose 1 Number Analyzed 20 participants
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 20 participants
4
  20.0%
Grade 3 Swelling, Dose 1 Number Analyzed 20 participants
0
   0.0%
Any Pain, Dose 2 Number Analyzed 17 participants
15
  88.2%
Grade 3 Pain, Dose 2 Number Analyzed 17 participants
1
   5.9%
Any Redness, Dose 2 Number Analyzed 17 participants
4
  23.5%
Grade 3 Redness, Dose 2 Number Analyzed 17 participants
1
   5.9%
Any Swelling, Dose 2 Number Analyzed 17 participants
3
  17.6%
Grade 3 Swelling, Dose 2 Number Analyzed 17 participants
0
   0.0%
Any Pain, Across doses Number Analyzed 20 participants
18
  90.0%
Grade 3 Pain, Across doses Number Analyzed 20 participants
3
  15.0%
Any Redness, Across doses Number Analyzed 20 participants
4
  20.0%
Grade 3 Redness, Across doses Number Analyzed 20 participants
1
   5.0%
Any Swelling, Across doses Number Analyzed 20 participants
5
  25.0%
Grade 3 Swelling, Across doses Number Analyzed 20 participants
0
   0.0%
32.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms, Headache, Malaise, Myalgia and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade. Grade 3 = incidence of a particular symptom that prevented normal, everyday activity. Grade 3 fever = axillary temperature above (>) 39.5 °C. Related = general symptom assessed by the investigator as causally related to the study 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 subjects with at least one vaccine administration documented.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 20 participants
8
  40.0%
Related Fatigue, Dose 1 Number Analyzed 20 participants
8
  40.0%
Grade 3 Fatigue, Dose 1 Number Analyzed 20 participants
0
   0.0%
Any Gastrointestinal symptoms, Dose 1 Number Analyzed 20 participants
3
  15.0%
Related Gastrointestinal symptoms, Dose 1 Number Analyzed 20 participants
3
  15.0%
Grade 3 Gastrointestinal symptoms, Dose 1 Number Analyzed 20 participants
0
   0.0%
Any Headache, Dose 1 Number Analyzed 20 participants
6
  30.0%
Related Headache, Dose 1 Number Analyzed 20 participants
6
  30.0%
Grade 3 Headache, Dose 1 Number Analyzed 20 participants
0
   0.0%
Any Malaise, Dose 1 Number Analyzed 20 participants
7
  35.0%
Related Malaise, Dose 1 Number Analyzed 20 participants
7
  35.0%
Grade 3 Malaise, Dose 1 Number Analyzed 20 participants
0
   0.0%
Any Myalgia, Dose 1 Number Analyzed 20 participants
3
  15.0%
Related Myalgia, Dose 1 Number Analyzed 20 participants
3
  15.0%
Grade 3 Myalgia, Dose 1 Number Analyzed 20 participants
0
   0.0%
Any Fever, Dose 1 Number Analyzed 20 participants
2
  10.0%
Related Fever, Dose 1 Number Analyzed 20 participants
2
  10.0%
Grade 3 Fever, Dose 1 Number Analyzed 20 participants
0
   0.0%
Any Fatigue, Dose 2 Number Analyzed 17 participants
11
  64.7%
Related Fatigue, Dose 2 Number Analyzed 17 participants
11
  64.7%
Grade 3 Fatigue, Dose 2 Number Analyzed 17 participants
2
  11.8%
Any Gastrointestinal symptoms, Dose 2 Number Analyzed 17 participants
4
  23.5%
Related Gastrointestinal symptoms, Dose 2 Number Analyzed 17 participants
4
  23.5%
Grade 3 Gastrointestinal symptoms, Dose 2 Number Analyzed 17 participants
0
   0.0%
Any Headache, Dose 2 Number Analyzed 17 participants
11
  64.7%
Related Headache, Dose 2 Number Analyzed 17 participants
10
  58.8%
Grade 3 Headache, Dose 2 Number Analyzed 17 participants
2
  11.8%
Any Malaise, Dose 2 Number Analyzed 17 participants
9
  52.9%
Related Malaise, Dose 2 Number Analyzed 17 participants
9
  52.9%
Grade 3 Malaise, Dose 2 Number Analyzed 17 participants
2
  11.8%
Any Myalgia, Dose 2 Number Analyzed 17 participants
8
  47.1%
Related Myalgia, Dose 2 Number Analyzed 17 participants
7
  41.2%
Grade 3 Myalgia, Dose 2 Number Analyzed 17 participants
2
  11.8%
Any Fever, Dose 2 Number Analyzed 17 participants
7
  41.2%
Related Fever, Dose 2 Number Analyzed 17 participants
5
  29.4%
Grade 3 Fever, Dose 2 Number Analyzed 17 participants
0
   0.0%
Any Fatigue, Across doses Number Analyzed 20 participants
14
  70.0%
Related Fatigue, Across doses Number Analyzed 20 participants
14
  70.0%
Grade 3 Fatigue, Across doses Number Analyzed 20 participants
2
  10.0%
Any Gastrointestinal symptoms, Across doses Number Analyzed 20 participants
6
  30.0%
Related Gastrointestinal symptoms, Across doses Number Analyzed 20 participants
6
  30.0%
Grade 3 Gastrointestinal symptoms, Across doses Number Analyzed 20 participants
0
   0.0%
Any Headache, Across doses Number Analyzed 20 participants
13
  65.0%
Related Headache, Across doses Number Analyzed 20 participants
13
  65.0%
Grade 3 Headache, Across doses Number Analyzed 20 participants
2
  10.0%
Any Malaise, Across doses Number Analyzed 20 participants
11
  55.0%
Related Malaise, Across doses Number Analyzed 20 participants
11
  55.0%
Grade 3 Malaise, Across doses Number Analyzed 20 participants
2
  10.0%
Any Myalgia, Across doses Number Analyzed 20 participants
10
  50.0%
Related Myalgia, Across doses Number Analyzed 20 participants
9
  45.0%
Grade 3 Myalgia, Across doses Number Analyzed 20 participants
2
  10.0%
Any Fever, Across doses Number Analyzed 20 participants
8
  40.0%
Related Fever, Across doses Number Analyzed 20 participants
6
  30.0%
Grade 3 Fever, Across doses Number Analyzed 20 participants
0
   0.0%
33.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 = an AE assessed by the investigator as causally related to the study 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 subjects with at least one vaccine administration documented.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
12
  60.0%
34.Primary Outcome
Title Number of Subjects With Potential Immune-Mediated Disease(s) (pIMDs)
Hide Description pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame During the entire study period (From Day 0 to Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description:
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period following each dose and across doses; unsolicited AEs: During the 30-day (Days 0-29) post-vaccination period; pIMDs: during the entire study period (From Day 0 to Month 7).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK 692342 Group
Hide Arm/Group Description Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
All-Cause Mortality
GSK 692342 Group
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
GSK 692342 Group
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
Psychiatric disorders   
Alcohol abuse   1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK 692342 Group
Affected / at Risk (%) # Events
Total   19/20 (95.00%)    
Gastrointestinal disorders   
Abdominal pain upper   1/20 (5.00%)  1
Aphthous stomatitis   1/20 (5.00%)  1
Diarrhoea   1/20 (5.00%)  1
Gastrointestinal disorder   6/20 (30.00%)  7
General disorders   
Fatigue   14/20 (70.00%)  19
Feeling hot   2/20 (10.00%)  2
Injection site warmth   1/20 (5.00%)  1
Malaise   12/20 (60.00%)  17
Pain   18/20 (90.00%)  33
Pyrexia   8/20 (40.00%)  9
Swelling   5/20 (25.00%)  7
Infections and infestations   
Cystitis   1/20 (5.00%)  1
Pertussis   1/20 (5.00%)  1
Rhinitis   1/20 (5.00%)  1
Sinusitis   2/20 (10.00%)  2
Upper respiratory tract infection   2/20 (10.00%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia   1/20 (5.00%)  1
Back pain   1/20 (5.00%)  1
Groin pain   1/20 (5.00%)  1
Muscular weakness   1/20 (5.00%)  1
Myalgia   10/20 (50.00%)  12
Nervous system disorders   
Dizziness   1/20 (5.00%)  1
Headache   13/20 (65.00%)  19
Migraine   1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
Erythema   4/20 (20.00%)  8
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01669096     History of Changes
Other Study ID Numbers: 116777
2012-002541-37 ( EudraCT Number )
First Submitted: August 16, 2012
First Posted: August 20, 2012
Results First Submitted: September 13, 2017
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019