Trial Outcomes & Findings for Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 (NCT NCT01669096)

Last Updated: 2019-03-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

At Day 0 prior to Dose 1

Results posted on

2019-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	GSK 692342 Group 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 Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK 692342 Group n=20 Participants 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.
Age, Continuous	33.7 Years STANDARD_DEVIATION 11.36 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized African/African American heritage	10 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian-East Asian heritage	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 0 prior to Dose 1

Population: 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.

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=18 Participants 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.
Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples	6279.7 fg/mL Interval 4624.2 to 8527.7

PRIMARY outcome

Timeframe: At Day 30 post-Dose 1

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=18 Participants 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.
Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples	7035.1 fg/mL Interval 5089.0 to 9725.5

PRIMARY outcome

Timeframe: At Day 31 post-Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=17 Participants 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.
Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples	64288.5 fg/mL Interval 33671.9 to 122743.5

PRIMARY outcome

Timeframe: At Day 37 post-Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=18 Participants 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.
Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples	32710.5 fg/mL Interval 23747.1 to 45057.0

PRIMARY outcome

Timeframe: At Day 40 post-Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=18 Participants 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.
Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples	8851.2 fg/mL Interval 5250.8 to 14920.4

PRIMARY outcome

Timeframe: At Day 44 post-Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=18 Participants 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.
Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples	6755.1 fg/mL Interval 4939.5 to 9238.0

PRIMARY outcome

Timeframe: At Day 47 post-Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=17 Participants 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.
Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples	7245.0 fg/mL Interval 5389.6 to 9739.3

PRIMARY outcome

Timeframe: At Day 0 prior to Dose 1

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).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers CD4+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13	97.0 T cells/million cells Interval 1.0 to 224.0
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers CD8+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13	95.0 T cells/million cells Interval 2.0 to 230.0

PRIMARY outcome

Timeframe: At Day 60 post-Dose 2

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).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Fusion Protein Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers CD4+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13	5200.0 T cells/million cells Interval 485.0 to 15302.0
Frequency of M72 Fusion Protein Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers CD8+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13	134.0 T cells/million cells Interval 54.0 to 635.5

PRIMARY outcome

Timeframe: At Day 0 prior -Dose 1

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(-).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M1	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M2	1.0 T cells/million cells Interval 1.0 to 26.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M3	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M4	96.0 T cells/million cells Interval 43.0 to 115.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M5	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M6	1.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M7	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M8	1.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M9	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M10	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M11	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M12	1.0 T cells/million cells Interval 1.0 to 13.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M13	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) M14	14.0 T cells/million cells Interval 1.0 to 17.0

PRIMARY outcome

Timeframe: At Day 0 prior-Dose 1

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(-).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M15	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M16	15.0 T cells/million cells Interval 1.0 to 42.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M17	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M18	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M19	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M20	13.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M21	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M22	1.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M23	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M24	1.0 T cells/million cells Interval 1.0 to 43.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M25	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M26	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M27	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M28	1.0 T cells/million cells Interval 1.0 to 14.0

PRIMARY outcome

Timeframe: At Day 0 prior - Dose 1

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(+).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M29	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M30	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M31	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M32	1.0 T cells/million cells Interval 1.0 to 227.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M33	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M34	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M35	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M36	1.0 T cells/million cells Interval 1.0 to 17.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M37	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M38	1.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M39	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M40	1.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M41	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M42	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 0 (prior- Dose 1)

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(-).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M43	1.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M44	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M45	1.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M46	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M47	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M48	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M49	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M50	1.0 T cells/million cells Interval 1.0 to 13.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M51	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M52	1.0 T cells/million cells Interval 1.0 to 28.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M53	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M54	1.0 T cells/million cells Interval 1.0 to 13.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M55	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M56	48.0 T cells/million cells Interval 1.0 to 90.0

PRIMARY outcome

Timeframe: At Day 0 (prior to Dose 1)

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(+).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M57	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M58	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M59	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M60	28.0 T cells/million cells Interval 6.0 to 56.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M61	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M62	13.0 T cells/million cells Interval 1.0 to 16.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M63	1.0 T cells/million cells Interval 1.0 to 25.0

PRIMARY outcome

Timeframe: At Day 60 post-Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M1	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M2	14.0 T cells/million cells Interval 1.0 to 28.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M3	21.5 T cells/million cells Interval 7.5 to 28.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M4	990.0 T cells/million cells Interval 517.5 to 1344.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M5	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M6	7.5 T cells/million cells Interval 1.0 to 24.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M7	28.5 T cells/million cells Interval 13.5 to 152.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M8	1830.5 T cells/million cells Interval 1084.5 to 3845.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M9	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M10	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M11	1.0 T cells/million cells Interval 1.0 to 7.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M12	142.5 T cells/million cells Interval 86.0 to 228.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M13	1.0 T cells/million cells Interval 1.0 to 1.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M14	1.0 T cells/million cells Interval 1.0 to 13.5

PRIMARY outcome

Timeframe: At Day 60 post - Dose 2

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(-).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M15	7.0 T cells/million cells Interval 1.0 to 55.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M16	1202.5 T cells/million cells Interval 561.5 to 1827.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M17	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M18	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M19	1.0 T cells/million cells Interval 1.0 to 15.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M20	300.0 T cells/million cells Interval 94.5 to 529.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M21	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M22	18.5 T cells/million cells Interval 13.5 to 28.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M23	1.0 T cells/million cells Interval 1.0 to 28.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M24	666.5 T cells/million cells Interval 230.5 to 1220.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M25	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M26	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M27	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M28	87.0 T cells/million cells Interval 40.5 to 179.5

PRIMARY outcome

Timeframe: At Day 60 post Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M29	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M30	1.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M31	1.0 T cells/million cells Interval 1.0 to 22.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M32	1198.5 T cells/million cells Interval 80.5 to 2845.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M33	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M34	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M35	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M36	28.0 T cells/million cells Interval 1.0 to 78.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M37	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M38	1.0 T cells/million cells Interval 1.0 to 7.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M39	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M40	69.0 T cells/million cells Interval 20.0 to 225.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M41	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M42	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 60 (post-Dose 2)

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M43	1.0 T cells/million cells Interval 1.0 to 14.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M44	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M45	13.5 T cells/million cells Interval 1.0 to 18.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M46	1.0 T cells/million cells Interval 1.0 to 7.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M47	66.0 T cells/million cells Interval 1.0 to 121.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M48	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M49	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M50	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M51	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M52	55.5 T cells/million cells Interval 29.0 to 184.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M53	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M54	28.0 T cells/million cells Interval 7.0 to 36.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M55	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) M56	163.0 T cells/million cells Interval 75.5 to 383.0

PRIMARY outcome

Timeframe: At Day 60 post- Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M61	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M57	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M58	1.0 T cells/million cells Interval 1.0 to 13.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M59	1.0 T cells/million cells Interval 1.0 to 7.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M60	15.0 T cells/million cells Interval 1.0 to 145.5
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M62	20.5 T cells/million cells Interval 1.0 to 34.0
Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M63	1.0 T cells/million cells Interval 1.0 to 50.0

PRIMARY outcome

Timeframe: At Day 0 prior-Dose 1

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(+).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M1	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M2	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M3	1.0 T cells/million cells Interval 1.0 to 23.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M4	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M5	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M6	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M7	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M8	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M9	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M10	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M11	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M12	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M13	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) M14	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 0 prior -Dose 1

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(+).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M15	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M16	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M17	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M18	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M19	6.0 T cells/million cells Interval 1.0 to 128.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M20	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M21	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M22	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M23	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M24	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M25	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M26	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M27	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) M28	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 0 prior- Dose 1

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(+).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M29	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M30	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M31	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M32	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M33	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M34	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M35	1.0 T cells/million cells Interval 1.0 to 62.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M36	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M37	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M38	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M39	32.0 T cells/million cells Interval 3.0 to 160.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M40	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M41	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) M42	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 0 prior to Dose 1

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(-).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M43	38.0 T cells/million cells Interval 4.0 to 69.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M44	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M45	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M46	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M47	66.0 T cells/million cells Interval 1.0 to 333.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M48	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M49	1.0 T cells/million cells Interval 1.0 to 31.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M50	1.0 T cells/million cells Interval 1.0 to 101.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M51	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M52	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M53	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M54	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M55	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) M56	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 0 (prior to Dose 1)

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(+).

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=13 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M57	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M58	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M59	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M60	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M61	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M62	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) M63	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 60 post-Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M1	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M2	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M3	1.0 T cells/million cells Interval 1.0 to 42.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M4	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M5	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M6	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M7	1.0 T cells/million cells Interval 1.0 to 10.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M8	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M9	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M10	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M11	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M12	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M13	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) M14	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 60 post -Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M15	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M16	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M17	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M18	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M19	1.0 T cells/million cells Interval 1.0 to 43.5
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M20	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M21	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M22	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M23	1.0 T cells/million cells Interval 1.0 to 22.5
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M24	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M25	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M26	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M27	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) M28	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 60 post- Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M29	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M30	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M31	1.0 T cells/million cells Interval 1.0 to 61.5
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M32	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M33	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M34	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M35	14.5 T cells/million cells Interval 1.0 to 110.5
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M36	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M37	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M38	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M39	40.5 T cells/million cells Interval 1.0 to 339.5
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M40	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M41	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) M42	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 60 post-Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M43	10.0 T cells/million cells Interval 1.0 to 189.5
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M44	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M45	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M46	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M47	109.0 T cells/million cells Interval 1.0 to 1432.5
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M48	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M49	1.0 T cells/million cells Interval 1.0 to 13.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M50	13.5 T cells/million cells Interval 1.0 to 64.5
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M51	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M52	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M53	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M54	45.0 T cells/million cells Interval 1.0 to 57.5
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M55	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) M56	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: At Day 60 post Dose 2

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=12 Participants 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.
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M57	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M58	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M59	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M60	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M61	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M62	1.0 T cells/million cells Interval 1.0 to 1.0
Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) M63	1.0 T cells/million cells Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: During the entire study period (from Day 0 to Month 7)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=20 Participants 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.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants

PRIMARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=20 Participants 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.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	5 Participants

PRIMARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=20 Participants 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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms, Dose 1	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms, Dose 1	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms, Dose 1	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Malaise, Dose 1	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Malaise, Dose 1	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Malaise, Dose 1	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms, Dose 2	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms, Dose 2	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms, Dose 2	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Malaise, Dose 2	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Malaise, Dose 2	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Malaise, Dose 2	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms, Across doses	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms, Across doses	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms, Across doses	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Malaise, Across doses	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Malaise, Across doses	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Malaise, Across doses	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across doses	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across doses	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across doses	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	0 Participants

PRIMARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=20 Participants 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.
Number of Subjects With Unsolicited Adverse Events (AEs)	12 Participants

PRIMARY outcome

Timeframe: During the entire study period (From Day 0 to Month 7)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure	GSK 692342 Group n=20 Participants 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.
Number of Subjects With Potential Immune-Mediated Disease(s) (pIMDs)	0 Participants

Adverse Events

GSK 692342 Group

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK 692342 Group n=20 participants at risk 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.
Psychiatric disorders Alcohol abuse	5.0% 1/20 • Number of events 1 • 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).

Other adverse events

Other adverse events
Measure	GSK 692342 Group n=20 participants at risk 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.
Gastrointestinal disorders Abdominal pain upper	5.0% 1/20 • Number of events 1 • 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).
Gastrointestinal disorders Aphthous stomatitis	5.0% 1/20 • Number of events 1 • 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).
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1 • 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).
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 1 • 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).
Infections and infestations Cystitis	5.0% 1/20 • Number of events 1 • 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).
Gastrointestinal disorders Diarrhoea	5.0% 1/20 • Number of events 1 • 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).
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • 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).
Skin and subcutaneous tissue disorders Erythema	20.0% 4/20 • Number of events 8 • 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).
General disorders Fatigue	70.0% 14/20 • Number of events 19 • 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).
General disorders Feeling hot	10.0% 2/20 • Number of events 2 • 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).
Gastrointestinal disorders Gastrointestinal disorder	30.0% 6/20 • Number of events 7 • 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).
Musculoskeletal and connective tissue disorders Groin pain	5.0% 1/20 • Number of events 1 • 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).
Nervous system disorders Headache	65.0% 13/20 • Number of events 19 • 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).
General disorders Injection site warmth	5.0% 1/20 • Number of events 1 • 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).
General disorders Malaise	60.0% 12/20 • Number of events 17 • 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).
Nervous system disorders Migraine	5.0% 1/20 • Number of events 1 • 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).
Musculoskeletal and connective tissue disorders Muscular weakness	5.0% 1/20 • Number of events 1 • 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).
Musculoskeletal and connective tissue disorders Myalgia	50.0% 10/20 • Number of events 12 • 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).
General disorders Pain	90.0% 18/20 • Number of events 33 • 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).
Infections and infestations Pertussis	5.0% 1/20 • Number of events 1 • 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).
General disorders Pyrexia	40.0% 8/20 • Number of events 9 • 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).
Infections and infestations Rhinitis	5.0% 1/20 • Number of events 1 • 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).
Infections and infestations Sinusitis	10.0% 2/20 • Number of events 2 • 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).
General disorders Swelling	25.0% 5/20 • Number of events 7 • 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).
Infections and infestations Upper respiratory tract infection	10.0% 2/20 • Number of events 2 • 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).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER