Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00805389
• Collaborator: (none)
• Enrollment: 713
• Locations: 14
• Arms: 5
• Actual Duration (Months): 30.9
• Patients Per Site: 50.9
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The aim of this Observer-blind study is to compare different Adjuvant Systems with the same, well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B (Engerix-BTM and FendrixTM), in order to better understand the immune response induced by each of the Adjuvant System.

This Protocol Posting has been updated following Protocol amendment 6, October 2009. The section impacted is Eligibility Criteria

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Biological: Engerix-B™; Biological: Fendrix™; Biological: GSK Biologicals' Hepatitis B vaccines (GSK223192A); Biological: HBsAg (Booster injection)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 713 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Comparison of the Immunogenicity and Safety of Various Investigational and Licensed Formulations of Hepatitis B Surface Antigen (HBsAg) Vaccines.
• Actual Study Start Date: Dec 15, 2008
• Actual Primary Completion Date: Sep 29, 2010
• Actual Study Completion Date: Jul 14, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GSK223192A 1 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Biological: GSK Biologicals' Hepatitis B vaccines (GSK223192A); 2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group; Biological: HBsAg (Booster injection); Single dose intramuscular injection
Experimental: GSK223192A 2 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Biological: GSK Biologicals' Hepatitis B vaccines (GSK223192A); 2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group; Biological: HBsAg (Booster injection); Single dose intramuscular injection
Experimental: GSK223192A 3 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Biological: GSK Biologicals' Hepatitis B vaccines (GSK223192A); 2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group; Biological: HBsAg (Booster injection); Single dose intramuscular injection
Experimental: Fendrix Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Biological: Fendrix™; 2 doses intramuscular injections; Biological: HBsAg (Booster injection); Single dose intramuscular injection
Active Comparator: Engerix-B Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Biological: Engerix-B™; 2 doses intramuscular injections; Biological: HBsAg (Booster injection); Single dose intramuscular injection

Outcome Measures

Primary Outcome Measures

1. Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells . [At Day 44]

   The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.

Secondary Outcome Measures

1. Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells [At Days 0, 14, 30 and 60]

   The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

2. Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. [At Days 0, 14, 30, 44, and 60]

   The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

3. Number of HB Specific CD4+ T Cells . [At Days 0, 180 and 360]

   The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

4. Number of HB - Specific CD8+ T Cells. [At Days 0, 180 and 360]

   The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

5. Number of HB - Specific CD4+ T Cells. [At Days 0, 360 and 374]

   The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

6. Number of HB - Specific CD8+ T Cells [At Days 0, 360 and 374]

   The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

7. Number of HB - Specific CD4+ T Cells [At Days 0, 14, 30, 33, 37, 44 and 60]

   The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.

8. Number of HB - Specific CD8+ T Cells [At Days 0, 14, 30, 44, 60 and 180]

   The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.

9. Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile [At Days 0, 14, 30, 44 and 60]

   The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

10. Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile [At Days 0 and 180]

    The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

11. Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) [At Days 0, 30, 44, and 60]

    Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

12. Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) [At Days 0, 180 and 360]

    Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

13. Anti-HB Antibody Concentrations in Serum, as Measured by CLIA [At Days 0, 374 and 390]

    Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

14. Number of Hepatitis B (HB)-Specific Memory B Cells [At Days 0, 30, 37, 44 and 60.]

    The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

15. Number of HB-specific Memory B Cells [At Days 180 and 360]

    The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

16. Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum [At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.]

    Concentrations of IFN-g, IL-1 beta (IL-1B), IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha (TNF-a), IFN-g-inducible protein-10 (IP-10) and monocyte chemotactic protein (MCP)-1 Concentrations of the IFN-g, IL-1B, IL-5, IL-6, IL-10, TNF-a, IP-10 and MCP-1 cytokines in serum were measured by Cytokine bead assay (CBA) and expressed in picograms per milliliter (pg/mL). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

17. Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) [At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.]

    Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

18. Normalized Levels of C-reactive Protein (CRP) [At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.]

    Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

19. Normalized Levels of WBC and of CPK [At Days 0, 30, 37 and 60.]

    Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.

20. Normalized Levels of CRP [At Days 0, 30 and 37.]

    Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.

21. Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils [At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.]

    Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

22. Levels of WBC, NEU, LYM, MON, EOS and BAS [At Days 0, 30, 37 and 60.]

    Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns all subjects except subjects part of the HLA Subsets 1 and 2.

23. Normalized Levels of Red Blood Cells and Platelets [At Days 0, 30, 37 and 60.]

    Analysis of levels of red blood cells (RBC) and platelets (PLA) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).

24. Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase [At Days 0, 30, 37 and 60.]

    Analysis of levels of haemoglobin (Hgb), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).

25. Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase [At Days 0, 30, 37 and 60.]

    Analysis of levels of serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).

26. Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. [At Day 0 and up to Day 60.]

    Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

27. Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. [At Day 0 and up to Day 60.]

    Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.

28. Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. [Post vaccination (up to Day 360)]

    Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.

29. Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. [At Days 360 and 390.]

    Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

30. Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase [At Day 0 and up to Day 60.]

    Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 60).

31. Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH [post vaccination (up to Day 360).]

    Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.

32. Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase [At Days 360 and 390.]

    Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

33. Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. [Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines.]

    Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination.

34. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. [Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine.]

    Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity.

35. Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. [Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens]

    Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

36. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. [Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens]

    Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

37. Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination [Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine]

    An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine.

38. Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination [Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens]

    An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.

39. Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) [During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.]

    AESIs included Autoimmune Disease (AID), neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, and other autoimmune/inflammatory events. Any AESI(s) = occurrence of any AESI(s) in a subject regardless of assessment of relationship to study vaccination. Related AESI(s) = Occurrence of AESI(s) in a subject assessed by the investigator as causally related to the study vaccination.

40. Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination [During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.]

    A SAE was defined as a medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = occurrence of SAE(s) in a subject regardless of assessment of relationship to study vaccination. Related SAE(s) = occurrence of occurrence of SAE(s) in a subject assessed by the investigators as causally related to the study vaccination.

41. Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) [At Days 0, 1, 14, 30, 31, 33 and 37]

    The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Tumor Necrosis Factor (TNF), Tumor Necrosis Factor Receptor Superfamily (TNFRSF9).

42. mRNA Levels as Measured by qPCR [At Days 0, 1, 14, 30, 31, 33 and 37]

    The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Fas associated factor 1 (FAF1), Signal Transducer And Activator Of Transcription 1(STAT1).

43. mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) [At Days 0, 1, 14, 30, 31, 33 and 37]

    The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interferon Regulatory Factor 1 (IRF1), MX Dynamin-Like GTPase 1(MX1).

44. Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) [At Days 0, 1, 14, 30, 31, 33 and 37]

    The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interleukin-12A (IL-12A), Marker Of Proliferation Ki-67 (MKI67).

45. Levels of mRNA as Measured by qPCR [At Days 0, 1, 14, 30, 31, 33 and 37]

    The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Chemokine Ligand 10 (CXCL10), Interleukin-1B (IL-1B).

46. Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR [At Days 0, 1, 14, 30, 31, 33 and 37]

    The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Dual Specificity Phosphatase 1 (DUSP1).

47. Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) [At Days 0, 1, 14, 30, 31, 33 and 37]

    The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Nuclear Factor Of Activated T-Cells, Cytoplasmic, Calcineurin-Dependent 2 (NFATC2) and Interferon-gamma (IFN-γ).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

All subjects must satisfy the following criteria at study entry :

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

• A male or female between, and including, 18 and 45 years at the time of the first vaccination.

• Written informed consent obtained from the subject.

• Healthy subjects as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.

• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion criteria:

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

• Previous vaccination against Hepatitis B.

• Positive for anti-HBs antibodies, antiHBc antibodies, HBsAg, HCV antibodies and/or HIV.

• Any previous administration of specific adjuvant components.

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the influenza vaccine (pandemic or seasonal) which can be administered > 21 days preceding or > 21 days following each primary vaccine dose (Doses 1 and 2) AND > 7 days preceding or > 7 days following the booster dose.

• Administration of immunoglobulins and/or any blood products within the last 3 months.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).

• Current serious neurologic or mental disease.

• Any past or current malignancies and lymphoproliferative disorders.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, autoimmune disease or anemia, as determined by physical examination or laboratory screening tests at the discretion of the investigator.

• Acute disease at the time of enrolment.

• Pregnant or lactating female.

• History of chronic alcohol consumption and/or drug abuse.

• Other conditions that the principal investigator judges may interfere with study findings.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bruxelles		Belgium	1200
2	GSK Investigational Site	Gent		Belgium	9000
3	GSK Investigational Site	La Louvière		Belgium	7100
4	GSK Investigational Site	Wilrijk		Belgium	2610
5	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg	Germany	72074
6	GSK Investigational Site	Haag	Bayern	Germany	83527
7	GSK Investigational Site	Muenchen	Bayern	Germany	80636
8	GSK Investigational Site	Muenchen	Bayern	Germany	81241
9	GSK Investigational Site	Regensburg	Bayern	Germany	93053
10	GSK Investigational Site	Wuerzburg	Bayern	Germany	97070
11	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55131
12	GSK Investigational Site	Berlin		Germany	12627
13	GSK Investigational Site	Berlin		Germany	13125
14	GSK Investigational Site	Hamburg		Germany	20253

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• IPD for this study will be made available via the Clinical Study Data Request site.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00805389
• Other Study ID Numbers: 112115
• First Posted: Dec 9, 2008
• Last Update Posted: Aug 20, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Adjuvant Systems; Hepatitis B
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis

Study Results

Participant Flow

Recruitment Details	Approximately 75 subjects in each group, approximately 23 and 52 subjects/group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I and II subtypes [Subset 1 and 2, respectively], received a booster dose of HBsAg at Day 360.
Pre-assignment Detail	Study duration was of 390 days for subjects in Subsets 1 and 2 (subjects identified with a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) vaccinated with an additional dose of Hepatitis B surface antigens (HBsAg)) and of 360 days for subjects not receiving this dose of HBsAg.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Period Title: Overall Study
STARTED	143	142	141	145	142
COMPLETED	136	137	129	128	129
NOT COMPLETED	7	5	12	17	13

Baseline Characteristics

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group	Total
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Total of all reporting groups
Overall Participants	143	142	141	145	142	713
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	34.7 (6.94)	33.7 (7.28)	32.9 (7.58)	33.5 (7.41)	32.9 (7.50)	33.5 (7.34)
Sex: Female, Male (Count of Participants)
Female	66 46.2%	66 46.5%	64 45.4%	66 45.5%	65 45.8%	327 45.9%
Male	77 53.8%	76 53.5%	77 54.6%	79 54.5%	77 54.2%	386 54.1%
Race/Ethnicity, Customized (Count of Participants)
White - Caucasian / European heritage	135 94.4%	138 97.2%	138 97.9%	142 97.9%	136 95.8%	689 96.6%

Outcome Measures

1. Primary Outcome

Title	Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells .
Description	The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.
Time Frame	At Day 44

Outcome Measure Data

Analysis Population Description

Analyses were performed on the According-to-Protocol (ATP) cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 44 time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	114	112	109	112	107
Median (Inter-Quartile Range) [HB-CD4+ T cells (per million cells)]	1345	1257	647	391	299

2. Secondary Outcome

Title	Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells
Description	The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time Frame	At Days 0, 14, 30 and 60

Outcome Measure Data

Analysis Population Description

Analyses were performed on the According-to-Protocol (ATP) cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30 or 60 time points.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	114	112	109	112	107
HB-CD4+, at Day 0	228	230	234	234	235
HB-CD4+, at Day 14	408	447	460	289	245
HB-CD4+, at Day 30	277	333	314	255	249
HB-CD4+, at Day 60	965	958	587	393	308

3. Secondary Outcome

Title	Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells.
Description	The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time Frame	At Days 0, 14, 30, 44, and 60

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	112	112	107	109	105
HB-CD8+, at Day 0	176	174	172	201	184
HB-CD8+, at Day 14	174	160	174	193	177
HB-CD8+, at Day 30	185	173	160	191	173
HB-CD8+, at Day 44	212	213	177	157	169
HB-CD8+, at Day 60	209	228	171	184	166

4. Secondary Outcome

Title	Number of HB Specific CD4+ T Cells .
Description	The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time Frame	At Days 0, 180 and 360

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	108	107	101	106	101
HB-CD4+, at Day 0	230	231	248	223	240
HB-CD4+, at Day 180	1090	954	546	360	334
HB-CD4+, at Day 360	960	829	564	388	350

5. Secondary Outcome

Title	Number of HB - Specific CD8+ T Cells.
Description	The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time Frame	At Days 0, 180 and 360

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	108	107	99	105	101
HB-CD8+, at Day 0	175	169	176	191	184
HB-CD8+, at Day 180	120	124	92	102	110
HB-CD8+, at Day 360	114	115	112	104	90

6. Secondary Outcome

Title	Number of HB - Specific CD4+ T Cells.
Description	The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time Frame	At Days 0, 360 and 374

Outcome Measure Data

Analysis Population Description

Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	54	51	53	52	48
HB-CD4+, at Day 0	228	233	254	234	266
HB-CD4+, at Day 360	1029	770	538	300	360
HB-CD4+, at Day 374	1006	1037	688	401	353

7. Secondary Outcome

Title	Number of HB - Specific CD8+ T Cells
Description	The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time Frame	At Days 0, 360 and 374

Outcome Measure Data

Analysis Population Description

Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	54	51	51	52	48
HB-CD8+, at Day 0	187	161	196	244	168
HB-CD8+, at Day 360	109	118	121	99	90
HB-CD8+, at Day 374	107	111	122	121	111

8. Secondary Outcome

Title	Number of HB - Specific CD4+ T Cells
Description	The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.
Time Frame	At Days 0, 14, 30, 33, 37, 44 and 60

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	17	14	15	19	14
HB-CD4+, at Day 0	68	98	25	48	31
HB-CD4+, at Day 14	425	498	149	75	85
HB-CD4+, at Day 30	313	314	243	67	110
HB-CD4+, at Day 33	114	270	110	63	126
HB-CD4+, at Day 37	844	869	486	67	174
HB-CD4+, at Day 44	2021	2890	1253	271	265
HB-CD4+, at Day 60	1291	1477	768	200	247

9. Secondary Outcome

Title	Number of HB - Specific CD8+ T Cells
Description	The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.
Time Frame	At Days 0, 14, 30, 44, 60 and 180

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	16	13	16	15	14
HB-CD4+, at Day 0	11	11	11	11	11
HB-CD4+, at Day 14	12	11	11	11	11
HB-CD4+, at Day 30	64	11	11	11	11
HB-CD4+, at Day 33	11	11	41	11	11
HB-CD4+, at Day 37	11	103	11	11	42
HB-CD4+, at Day 44	11	99	11	11	11
HB-CD4+, at Day 60	37	102	11	11	11

10. Secondary Outcome

Title	Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile
Description	The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time Frame	At Days 0, 14, 30, 44 and 60

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	114	112	109	112	107
HB-CD4+, Th1, at Day 0	65	62	53	70	67
HB-CD4+, Th1, at Day 14	64	75	68	81	66
HB-CD4+, Th1, at Day 30	61	66	75	64	72
HB-CD4+, Th1, at Day 44	155	174	95	74	64
HB-CD4+, Th1, at Day 60	119	141	90	94	61
HB-CD4+, Th2, at Day 0	50	63	55	53	52
HB-CD4+, Th2, at Day 14	52	58	60	42	57
HB-CD4+, Th2, at Day 30	39	52	56	45	47
HB-CD4+, Th2, at Day 44	85	77	87	55	74
HB-CD4+, Th2, at Day 60	78	58	71	53	59

11. Secondary Outcome

Title	Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile
Description	The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time Frame	At Days 0 and 180

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	106	107	98	106	101
HB-CD4+, Th1, at Day 0	66	63	53	65	64
HB-CD4+, Th1, at Day 180	129	137	76	68	70
HB-CD4+, Th2, at Day 0	51	64	57	50	48
HB-CD4+, Th2, at Day 180	54	63	46	54	49

12. Secondary Outcome

Title	Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)
Description	Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 0, 30, 44, and 60

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	59	57	58	62	57
Anti HBs, Day 0	3.1	0	3.3	0	0
Anti HBs, Day 30	108.0	59.6	66.3	6.1	3.5
Anti HBs, Day 44	11986.2	7942.6	5525.4	220.2	19.2
Anti HBs, Day 60	7454.3	5030.9	4194.3	251.9	21.5

13. Secondary Outcome

Title	Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)
Description	Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 0, 180 and 360

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	58	54	55	56	54
Anti HBs, Day 0	3.1	3.1	3.3	3.1	3.1
Anti HBs, Day 180	3840.7	2657.5	3330.2	254.5	39.0
Anti HBs, Day 360	2150.7	1650.6	2122.5	94.5	19.8

14. Secondary Outcome

Title	Anti-HB Antibody Concentrations in Serum, as Measured by CLIA
Description	Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 0, 374 and 390

Outcome Measure Data

Analysis Population Description

Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	55	52	54	54	50
Anti HBs, Day 0	3.1	3.1	3.3	3.1	3.1
Anti HBs, Day 374	51509.0	31985.9	27135.3	3788.4	341.3
Anti HBs, Day 390	43674.6	27035.7	25105.7	3352.2	351.1

15. Secondary Outcome

Title	Number of Hepatitis B (HB)-Specific Memory B Cells
Description	The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 0, 30, 37, 44 and 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	54	53	55	54	52
HB-mem B cells, at Day 0	14	1	1	1	1
HB-mem B cells, at Day 30	296	186	265	28	1
HB-mem B cells, at Day 37	3817	3577	2597	71	19
HB-mem B cells, at Day 44	4656	4808	2498	51	28
HB-mem B cells, at Day 60	3742	3383	1806	47	44

16. Secondary Outcome

Title	Number of HB-specific Memory B Cells
Description	The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 180 and 360

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	53	51	52	50	51
HB-mem B cells, at Day 180	1454	1013	1410	24	1
HB-mem B cells, at Day 360	1070	1437	1473	66	21

17. Secondary Outcome

Title	Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum
Description	Concentrations of IFN-g, IL-1 beta (IL-1B), IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha (TNF-a), IFN-g-inducible protein-10 (IP-10) and monocyte chemotactic protein (MCP)-1 Concentrations of the IFN-g, IL-1B, IL-5, IL-6, IL-10, TNF-a, IP-10 and MCP-1 cytokines in serum were measured by Cytokine bead assay (CBA) and expressed in picograms per milliliter (pg/mL). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	59	57	61	61	55
IFN-g; Day 0	3.704	3.704	3.704	3.704	3.704
IFN-g; Day 0+	3.704	3.704	3.704	3.704	3.704
IFN-g; Day 1	3.704	3.704	3.704	3.704	3.704
IFN-g; Day 30	3.704	3.704	3.704	3.704	3.704
IFN-g; Day 30+	3.704	3.704	3.704	3.704	3.704
IFN-g; Day 31	5.568	3.704	3.704	3.704	3.704
IFN-g; Day 33	3.704	3.704	3.704	3.704	3.704
IFN-g; Day 37	3.704	3.704	3.704	3.704	3.704
IL-1B; Day 0	0.411	1.379	0.411	0.411	0.411
IL-1B; Day 0+	1.636	1.873	0.856	0.947	1.146
IL-1B; Day 1	2.024	2.237	1.912	1.628	1.885
IL-1B; Day 30	1.232	0.879	1.017	0.925	0.411
IL-1B; Day 30+	1.292	1.099	0.856	1.214	1.349
IL-1B; Day 31	0.991	1.263	1.117	1.159	1.135
IL-1B; Day 33	0.411	0.411	0.411	0.411	0.86
IL-1B; Day 37	0.411	0.411	0.411	0.411	0.411
IL-10; Day 0	0.411	0.411	0.411	0.411	0.411
IL-10; Day 0+	0.411	0.411	0.411	0.411	0.411
IL-10; Day 1	0.977	1.08	1.055	0.893	0.916
IL-10; Day 30	0.411	0.411	0.411	0.411	0.411
IL-10; Day 30+	0.411	0.411	0.411	0.411	0.411
IL-10; Day 31	0.705	0.411	0.411	0.411	0.411
IL-10; Day 33	0.411	0.411	0.411	0.411	0.411
IL-10; Day 37	0.411	0.411	0.411	0.411	0.411
IL-5; Day 0	0.411	0.411	0.905	0.867	0.411
IL-5; Day 0+	1.161	1.37	0.905	0.411	1.092
IL-5; Day 1	2.004	2.089	1.83	1.77	1.942
IL-5; Day 30	1.202	0.411	1.011	0.89	0.411
IL-5; Day 30+	0.884	0.916	0.411	0.992	0.411
IL-5; Day 31	1.119	0.951	1.289	1.113	0.99
IL-5; Day 33	0.411	0.411	1.192	0.411	0.411
IL-5; Day 37	0.411	0.411	0.411	0.411	0.411
IL-6; Day 0	1.291	1.19	1.291	1.26	1.055
IL-6; Day 0+	2.882	2.523	1.605	1.579	1.418
IL-6; Day 1	4.07	2.578	2.223	2.147	1.739
IL-6; Day 30	1.641	1.377	1.79	1.653	1.218
IL-6; Day 30+	3.195	2.53	1.664	1.753	1.394
IL-6; Day 31	7.459	4.174	3.457	2.538	1.567
IL-6; Day 33	1.644	1.253	1.435	1.676	1.389
IL-6; Day 37	1.003	0.976	0.95	1.321	1.158
IP-10; Day 0	94	92	101.5	102	91
IP-10; Day 0+	80	81	78	80	75.5
IP-10; Day 1	147	111	92.5	85.5	85
IP-10; Day 30	103	109	106	104	107
IP-10; Day 30+	75	63	70.5	68	70
IP-10; Day 31	295	211	176.5	63	76
IP-10; Day 33	232	170	156	86	84
IP-10; Day 37	119	100.5	90	83.5	85
MCP-1; Day 0	130	168	148.5	143	120
MCP-1; Day 0+	112	141	114	131	95
MCP-1; Day 1	144	139	111.5	133.5	133
MCP-1; Day 30	151	179	164	165	161
MCP-1; Day 30+	140	114	121.5	121	114.5
MCP-1; Day 31	171	155	114.5	120	105
MCP-1; Day 33	83	92	79	122	88
MCP-1; Day 37	129	138.5	150	140.5	133
TNF-a; Day 0	0.411	1.262	0.411	0.651	0.411
TNF-a; Day 0+	1.482	1.641	0.411	0.411	0.911
TNF-a; Day 1	1.902	1.909	1.727	1.579	1.701
TNF-a; Day 30	0.969	1.023	1.203	0.411	0.411
TNF-a; Day 30+	1.069	1.08	1.321	1.243	1.323
TNF-a; Day 31	0.881	1.151	1.081	1.091	1.375
TNF-a; Day 33	0.411	0.981	1.129	0.411	0.411
TNF-a; Day 37	0.411	0.934	0.411	0.411	0.841

18. Secondary Outcome

Title	Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK)
Description	Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	59	57	59	61	55
WBC; Day 0	6840	6090	6650	6523.81	6480
WBC; Day 0+	7729.231	7670	7520	7620	7210
WBC; Day 1	8265	7850	7610	8400	7130
WBC; Day 30	5960	6090	6290	6421.053	6076.923
WBC; Day 30+	7570	7350	7120	7371.429	7625
WBC; Day 31	8160	7533.333	7422.222	7980	6550
WBC; Day 33	6450	6080	6290	7150	6170
WBC; Day 37	6219.048	6464.341	6760	6740	6870
WBC; Day 60	6400	6320	6090	6540	5970
CPK; Day 0	113	93	110	114	84.108
CPK; Day 0+	117	99.297	112	114.842	94
CPK; Day 1	109	89.784	104	102	86
CPK, at Day 30	123.263	90	115.73	99	93
CPK; Day 30+	120	91.772	115.73	106	93
CPK; Day 31	109	90	106.973	103.614	98
CPK; Day 33	107	87	104	101	91.772
CPK; Day 37	112.118	93.986	118	106.311	93.689
CPK; Day 60	120	85	114	110.647	96

19. Secondary Outcome

Title	Normalized Levels of C-reactive Protein (CRP)
Description	Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	59	57	59	61	55
CRP; Day 0	0.248	0.248	0.248	0.248	0.248
CRP; Day 0+	0.248	0.248	0.248	0.248	0.248
CRP; Day 1	1.97	0.962	0.486	0.462	0.248
CRP; Day 30	0.248	0.248	0.248	0.248	0.248
CRP; Day 30+	0.248	0.248	0.248	0.248	0.248
CRP; Day 31	1.521	1.047	0.61	0.486	0.248
CRP; Day 33	2.6	1.2	0.707	0.486	0.248
CRP; Day 37	0.319	0.248	0.248	0.248	0.248

20. Secondary Outcome

Title	Normalized Levels of WBC and of CPK
Description	Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.
Time Frame	At Days 0, 30, 37 and 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 - Non-HLA Subsets Group	GSK223192A 2 - Non-HLA Subsets Group	GSK223192A 3 - Non-HLA Subsets Group	Fendrix - Non-HLA Subsets Group	Engerix-B - Non-HLA Subsets Group
Arm/Group Description	This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	68	68	66	71	67
WBC; Day 0	6627.764	6748.689	6782.414	7590	6810
WBC; Day 30	6870.05	6454.545	6600	6950.82	6590
WBC; Day 37	6736.842	7196.579	6550	6673.182	6440
WBC; Day 60	6738.636	6330	6625.789	7175.909	6740
CPK; Day 0	105.529	102.696	109.756	114	120.857
CPK; Day 30	108.617	103.647	114	102.1	113.079
CPK; Day 37	105.351	99.399	109.294	122.66	124.667
CPK; Day 60	112.842	104	107.6	102.4	120.989

21. Secondary Outcome

Title	Normalized Levels of CRP
Description	Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.
Time Frame	At Days 0, 30 and 37.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 - Non-HLA Subsets Group	GSK223192A 2 - Non-HLA Subsets Group	GSK223192A 3 - Non-HLA Subsets Group	Fendrix - Non-HLA Subsets Group	Engerix-B - Non-HLA Subsets Group
Arm/Group Description	This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	66	66	64	69	66
CRP; Day 0	0.33	0.486	0.253	0.296	0.365
CRP; Day 30	0.248	0.371	0.38	0.277	0.319
CRP; Day 37	0.486	0.523	0.486	0.363	0.248

22. Secondary Outcome

Title	Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Description	Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	21	17	14	22	14
WBC; Day 0	0.498	0.509	0.341	0.43	0.479
WBC; Day 0+	0.702	1.123	0.578	0.647	0.662
WBC; Day 1	0.76	0.756	0.54	0.698	0.607
WBC; Day 30	0.456	0.596	0.263	0.385	0.517
WBC; Day 30+	0.69	0.789	0.574	0.556	0.76
WBC; Day 31	0.79	0.737	0.629	0.633	0.536
WBC; Day 33	0.441	0.491	0.404	0.441	0.537
WBC; Day 37	0.379	0.525	0.468	0.354	0.49
WBC; Day 60	0.41	0.557	0.271	0.42	0.446
NEU; Day 0	0.648	0.53	0.58	0.663	0.445
NEU; Day 0+	0.84	0.752	0.693	0.767	0.654
NEU; Day 1	0.93	0.817	0.727	0.769	0.654
NEU; Day 30	0.604	0.6	0.387	0.578	0.581
NEU; Day 30+	0.9	0.717	0.609	0.663	0.642
NEU; Day 31	1.161	0.959	0.921	0.78	0.589
NEU; Day 33	0.591	0.509	0.539	0.587	0.567
NEU; Day 37	0.63	0.652	0.443	0.569	0.542
NEU; Day 60	0.656	0.543	0.54	0.61	0.561
LYM; Day 0	0.474	0.366	0.531	0.403	0.68
LYM; Day 0+	0.328	0.407	0.543	0.361	0.609
LYM; Day 1	0.178	0.272	0.412	0.283	0.478
LYM; Day 30	0.452	0.51	0.528	0.433	0.536
LYM; Day 30+	0.3	0.386	0.497	0.413	0.54
LYM; Day 31	-0.086	-0.003	0.15	0.302	0.54
LYM; Day 33	0.309	0.407	0.445	0.405	0.622
LYM; Day 37	0.503	0.357	0.555	0.423	0.572
LYM; Day 60	0.452	0.376	0.534	0.402	0.538
MON; Day 0	0.5	0.311	0.439	0.51	0.489
MON; Day 0+	0.422	0.367	0.367	0.439	0.389
MON; Day 1	0.594	0.522	0.522	0.477	0.45
MON; Day 30	0.533	0.411	0.5	0.472	0.422
MON; Day 30+	0.456	0.422	0.433	0.443	0.363
MON; Day 31	0.533	0.544	0.632	0.427	0.478
MON; Day 33	0.767	0.578	0.656	0.549	0.472
MON; Day 37	0.478	0.433	0.433	0.472	0.394
MON; Day 60	0.5	0.467	0.456	0.461	0.344
EOS; Day 0	0.5	0.594	0.37	0.596	0.495
EOS; Day 0+	0.3	0.429	0.25	0.423	0.42
EOS; Day 1	0.291	0.48	0.313	0.464	0.41
EOS; Day 30	0.45	0.673	0.42	0.693	0.53
EOS; Day 30+	0.32	0.475	0.34	0.496	0.38
EOS; Day 31	0.145	0.38	0.25	0.505	0.43
EOS; Day 33	0.6	0.667	0.58	0.645	0.443
EOS; Day 37	0.46	0.64	0.44	0.69	0.52
EOS; Day 60	0.45	0.652	0.38	0.709	0.465
BAS; Day 0	0.25	0.35	0.325	0.25	0.375
BAS; Day 0+	0.25	0.3	0.232	0.25	0.225
BAS; Day 1	0.232	0.25	0.286	0.179	0.25
BAS; Day 30	0.4	0.35	0.35	0.333	0.3
BAS; Day 30+	0.25	0.25	0.25	0.211	0.333
BAS; Day 31	0.2	0.3	0.3	0.25	0.325
BAS; Day 33	0.35	0.4	0.35	0.3	0.3
BAS; Day 37	0.316	0.421	0.286	0.286	0.3
BAS; Day 60	0.3	0.4	0.4	0.25	0.308

23. Secondary Outcome

Title	Levels of WBC, NEU, LYM, MON, EOS and BAS
Description	Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns all subjects except subjects part of the HLA Subsets 1 and 2.
Time Frame	At Days 0, 30, 37 and 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 - Non-HLA Subsets Group	GSK223192A 2 - Non-HLA Subsets Group	GSK223192A 3 - Non-HLA Subsets Group	Fendrix - Non-HLA Subsets Group	Engerix-B - Non-HLA Subsets Group
Arm/Group Description	This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	47	47	42	43	47
WBC; Day 0	0.426	0.413	0.497	0.672	0.465
WBC; Day 30	0.492	0.426	0.428	0.573	0.455
WBC; Day 37	0.455	0.574	0.405	0.523	0.426
WBC; Day 60	0.44	0.44	0.439	0.607	0.478
NEU; Day 0	0.534	0.559	0.426	0.503	0.458
NEU; Day 30	0.457	0.524	0.491	0.5	0.532
NEU; Day 37	0.417	0.5	0.436	0.458	0.491
NEU; Day 60	0.47	0.496	0.389	0.471	0.474
LYM; Day 0	0.408	0.388	0.552	0.37	0.45
LYM; Day 30	0.45	0.404	0.55	0.373	0.43
LYM; Day 37	0.514	0.433	0.605	0.492	0.43
LYM; Day 60	0.45	0.388	0.578	0.426	0.417
MON; Day 0	0.52	0.473	0.5	0.438	0.55
MON; Day 30	0.556	0.471	0.538	0.431	0.506
MON; Day 37	0.471	0.456	0.465	0.465	0.5
MON; Day 60	0.463	0.41	0.444	0.456	0.5
EOS; Day 0	0.304	0.29	0.275	0.299	0.319
EOS; Day 30	0.4	0.4	0.35	0.375	0.333
EOS; Day 37	0.409	0.35	0.329	0.496	0.522
EOS; Day 60	0.429	0.324	0.299	0.347	0.388
BAS; Day 0	0.263	0.286	0.3	0.353	0.353
BAS; Day 30	0.3	0.294	0.316	0.294	0.316
BAS; Day 37	0.351	0.294	0.377	0.353	0.3
BAS; Day 60	0.3	0.2	0.4	0.343	0.286

24. Secondary Outcome

Title	Normalized Levels of Red Blood Cells and Platelets
Description	Analysis of levels of red blood cells (RBC) and platelets (PLA) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).
Time Frame	At Days 0, 30, 37 and 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	143	142	141	145	142
RBC; Day 0	4.45	4.433	4.464	4.38	4.456
RBC; Day 30	4.461	4.382	4.423	4.388	4.486
RBC; Day 37	4.372	4.346	4.395	4.37	4.388
RBC; Day 60	4.421	4.393	4.364	4.371	4.4
PLA; Day 0	269318.18	270833.33	270000	267187.5	259000
PLA; Day 30	261363.64	262000	260470.78	274431.82	258333.33
PLA; Day 37	295000	274431.82	269000	282477.27	268622.45
PLA; Day 60	263333.33	267045.46	259000	273239.44	262588.03

25. Secondary Outcome

Title	Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase
Description	Analysis of levels of haemoglobin (Hgb), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).
Time Frame	At Days 0, 30, 37 and 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	143	142	141	145	142
Hgb; Day 0	13.4	13.35	13.4	13.275	13.35
Hgb; Day 30	13.35	13.186	13.275	13.121	13.35
Hgb; Day 37	13.05	12.957	13.025	13.05	13.05
Hgb; Day 60	13.275	13.136	13.1	12.975	13.163
ALT; Day 0	21.086	18.792	18.636	21.8	21.32
ALT; Day 30	21.32	18.743	19.897	20.5	18.743
ALT; Day 37	21.221	18.767	18.596	20.7	19.8
ALT; Day 60	21.161	17.447	18.07	20.541	18.518
AST; Day 0	21	20	20	21	20.478
AST; Day 30	20.72	19.24	20.188	20	19.097
AST; Day 37	20.881	19.097	20.043	20	20
AST; Day 60	20.72	17.986	20.76	21	19.339

26. Secondary Outcome

Title	Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase
Description	Analysis of levels of serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).
Time Frame	At Days 0, 30, 37 and 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	143	142	141	145	142
S-CREA; Day 0	0.893	0.841	0.889	0.86	0.85
S-CREA, at Day 30	0.9	0.84	0.874	0.888	0.87
S-CREA; Day 37	0.906	0.83	0.883	0.92	0.909
S-CREA; Day 60	0.92	0.84	0.873	0.934	0.915
UREA; Day 0	29.5	28.667	30.095	30	29.202
UREA; Day 30	30.127	28.667	30.462	30.048	30.095
UREA; Day 37	29.5	27.833	30.333	31	28.667
UREA; Day 60	29.8	28.905	29.5	30.095	29.65
LHD; Day 0	336.364	335.281	328.3	336.054	325.85
LHD; Day 30	343.75	329.6	330.32	337.428	320.671
LHD; Day 37	348.894	342.857	331.967	340.606	319.048
LHD; Day 60	341.975	335.141	324.675	348.438	320.927

27. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.
Description	Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Day 0 and up to Day 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	75	74	75	74	75
BAS Abn. Day 0 - Abn. Day 60	3 2.1%	2 1.4%	2 1.4%	3 2.1%	4 2.8%
BAS Abn. Day 0 - Nor. Day 60	0 0%	0 0%	2 1.4%	2 1.4%	0 0%
BAS Nor. Day 0 - Abn. Day 60	11 7.7%	10 7%	9 6.4%	5 3.4%	7 4.9%
BAS Nor. Day 0 - Nor. Day 60	61 42.7%	62 43.7%	62 44%	64 44.1%	64 45.1%
CPK Abn. Day 0 - Abn. Day 60	12 8.4%	11 7.7%	13 9.2%	12 8.3%	8 5.6%
CPK Abn. Day 0 - Nor. Day 60	0 0%	0 0%	0 0%	2 1.4%	2 1.4%
CPK Nor. Day 0 - Abn. Day 60	21 14.7%	9 6.3%	18 12.8%	20 13.8%	14 9.9%
CPK Nor. Day 0 - Nor. Day 60	42 29.4%	54 38%	44 31.2%	40 27.6%	51 35.9%
CRP Abn. Day 0 - Abn. Day 60	3 2.1%	8 5.6%	5 3.5%	4 2.8%	3 2.1%
CRP Abn. Day 0 - Nor. Day 60	0 0%	0 0%	0 0%	0 0%	1 0.7%
CRP Nor. Day 0 - Abn. Day 60	56 39.2%	33 23.2%	22 15.6%	14 9.7%	8 5.6%
CRP Nor. Day 0 - Nor. Day 60	16 11.2%	33 23.2%	48 34%	56 38.6%	62 43.7%
EOS Abn. Day 0 - Abn. Day 60]	3 2.1%	6 4.2%	3 2.1%	7 4.8%	3 2.1%
EOS Abn. Day 0 - Nor. Day 60	1 0.7%	0 0%	1 0.7%	1 0.7%	1 0.7%
EOS Nor. Day 0 - Abn. Day 60	13 9.1%	9 6.3%	6 4.3%	6 4.1%	6 4.2%
EOS Nor. Day 0 - Nor. Day 60	58 40.6%	59 41.5%	65 46.1%	60 41.4%	65 45.8%
LYM Abn. Day 0 - Abn. Day 60	10 7%	6 4.2%	7 5%	6 4.1%	5 3.5%
LYM Abn. Day 0 - Nor. Day 60	0 0%	0 0%	1 0.7%	1 0.7%	1 0.7%
LYM Nor. Day 0 - Abn. Day 60	30 21%	29 20.4%	16 11.3%	11 7.6%	10 7%
LYM Nor. Day 0 - Nor. Day 60	35 24.5%	39 27.5%	51 36.2%	56 38.6%	59 41.5%
MON Abn. Day 0 - Abn. Day 60	1 0.7%	3 2.1%	4 2.8%	4 2.8%	0 0%
MON Abn. Day 0 - Nor. Day 60	0 0%	2 1.4%	3 2.1%	0 0%	0 0%
MON Nor. Day 0 - Abn. Day 60	29 20.3%	15 10.6%	12 8.5%	8 5.5%	6 4.2%
MON Nor. Day 0 - Nor. Day 60	45 31.5%	54 38%	56 39.7%	62 42.8%	69 48.6%
NEU Abn. Day 0 - Abn. Day 60	7 4.9%	2 1.4%	3 2.1%	3 2.1%	0 0%
NEU Abn. Day 0 - Nor. Day 60	0 0%	1 0.7%	0 0%	1 0.7%	0 0%
NEU Nor. Day 0 - Abn. Day 60	32 22.4%	27 19%	19 13.5%	13 9%	8 5.6%
NEU Nor. Day 0 - Nor. Day 60	36 25.2%	44 31%	53 37.6%	57 39.3%	67 47.2%
WBC Abn. Day 0 - Abn. Day 60	6 4.2%	5 3.5%	9 6.4%	2 1.4%	6 4.2%
WBC Abn. Day 0 - Nor. Day 60	0 0%	1 0.7%	1 0.7%	1 0.7%	1 0.7%
WBC Nor. Day 0 - Abn. Day 60	30 21%	26 18.3%	19 13.5%	19 13.1%	14 9.9%
WBC Nor. Day 0 - Nor. Day 60	39 27.3%	42 29.6%	46 32.6%	52 35.9%	54 38%

28. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.
Description	Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.
Time Frame	At Day 0 and up to Day 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 - Non-HLA Subsets Group	GSK223192A 2 - Non-HLA Subsets Group	GSK223192A 3 - Non-HLA Subsets Group	Fendrix - Non-HLA Subsets Group	Engerix-B - Non-HLA Subsets Group
Arm/Group Description	This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	68	67	65	70	66
BAS Abn. Day 0 - Abn. Day 60	1 0.7%	4 2.8%	1 0.7%	3 2.1%	1 0.7%
BAS Abn. Day 0 - Nor. Day 60	3 2.1%	0 0%	1 0.7%	3 2.1%	2 1.4%
BAS Nor. Day 0 - Abn. Day 60	5 3.5%	6 4.2%	3 2.1%	6 4.1%	3 2.1%
BAS Nor. Day 0 - Nor. Day 60	59 41.3%	56 39.4%	60 42.6%	58 40%	60 42.3%
CPK Abn. Day 0 - Abn. Day 60	10 7%	6 4.2%	12 8.5%	8 5.5%	11 7.7%
CPK Abn. Day 0 - Nor. Day 60	2 1.4%	1 0.7%	6 4.3%	5 3.4%	6 4.2%
CPK Nor. Day 0 - Abn. Day 60	14 9.8%	9 6.3%	9 6.4%	12 8.3%	12 8.5%
CPK Nor. Day 0 - Nor. Day 60	42 29.4%	51 35.9%	38 27%	45 31%	37 26.1%
CRP Abn. Day 0 - Abn. Day 60	5 3.5%	11 7.7%	8 5.7%	4 2.8%	5 3.5%
CRP Abn. Day 0 - Nor. Day 60	3 2.1%	1 0.7%	1 0.7%	1 0.7%	3 2.1%
CRP Nor. Day 0 - Abn. Day 60	6 4.2%	9 6.3%	9 6.4%	4 2.8%	6 4.2%
CRP Nor. Day 0 - Nor. Day 60	51 35.7%	42 29.6%	45 31.9%	58 40%	50 35.2%
EOS Abn. Day 0 - Abn. Day 60	8 5.6%	6 4.2%	5 3.5%	4 2.8%	5 3.5%
EOS Abn. Day 0 - Nor. Day 60	1 0.7%	3 2.1%	0 0%	2 1.4%	2 1.4%
EOS Nor. Day 0 - Abn. Day 60	8 5.6%	8 5.6%	8 5.7%	14 9.7%	8 5.6%
EOS Nor. Day 0 - Nor. Day 60	51 35.7%	49 34.5%	52 36.9%	50 34.5%	51 35.9%
LYM Abn. Day 0 - Abn. Day 60	5 3.5%	4 2.8%	6 4.3%	9 6.2%	7 4.9%
LYM Abn. Day 0 - Nor. Day 60	3 2.1%	6 4.2%	1 0.7%	5 3.4%	4 2.8%
LYM Nor. Day 0 - Abn. Day 60	10 7%	10 7%	13 9.2%	6 4.1%	12 8.5%
LYM Nor. Day 0 - Nor. Day 60	50 35%	46 32.4%	45 31.9%	50 34.5%	43 30.3%
MON Abn. Day 0 - Abn. Day 60	0 0%	2 1.4%	3 2.1%	2 1.4%	2 1.4%
MON Abn. Day 0 - Nor. Day 60	4 2.8%	1 0.7%	0 0%	2 1.4%	1 0.7%
MON Nor. Day 0 - Abn. Day 60	8 5.6%	9 6.3%	9 6.4%	4 2.8%	6 4.2%
MON Nor. Day 0 - Nor. Day 60	56 39.2%	54 38%	53 37.6%	62 42.8%	57 40.1%
NEU Abn. Day 0 - Abn. Day 60	3 2.1%	4 2.8%	3 2.1%	3 2.1%	5 3.5%
NEU Abn. Day 0 - Nor. Day 60	2 1.4%	4 2.8%	3 2.1%	3 2.1%	3 2.1%
NEU Nor. Day 0 - Abn. Day 60	9 6.3%	12 8.5%	17 12.1%	13 9%	5 3.5%
NEU Nor. Day 0 - Nor. Day 60	54 37.8%	46 32.4%	42 29.8%	51 35.2%	53 37.3%
WBC Abn. Day 0 - Abn. Day 60	5 3.5%	7 4.9%	5 3.5%	11 7.6%	8 5.6%
WBC Abn. Day 0 - Nor. Day 60	2 1.4%	3 2.1%	4 2.8%	1 0.7%	1 0.7%
WBC Nor. Day 0 - Abn. Day 60	7 4.9%	7 4.9%	7 5%	10 6.9%	6 4.2%
WBC Nor. Day 0 - Nor. Day 60	54 37.8%	50 35.2%	49 34.8%	48 33.1%	51 35.9%

29. Secondary Outcome

Title	Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.
Description	Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.
Time Frame	Post vaccination (up to Day 360)

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	138	140	131	133	135
BAS Abn.	12	13	13	11	12
BAS Nor.	126	127	118	122	123
CPK Abn.	35	25	36	38	37
CPK Nor.	103	115	95	95	98
EOS Abn.	13	20	20	19	10
EOS Nor.	125	120	111	114	125
LYM Abn.	19	22	19	22	25
LYM Nor.	119	118	112	111	110
MON Abn.	12	10	13	14	9
MON Nor.	126	130	118	119	126
NEU Abn.	14	18	24	16	15
NEU Nor.	124	122	107	117	120
WBC Abn.	20	18	25	14	20
WBC Nor.	118	122	106	119	115

30. Secondary Outcome

Title	Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.
Description	Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 360 and 390.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	59	56	56	54	54
BAS Abn. Day 360 - Abn. Day 390	2 1.4%	1 0.7%	0 0%	0 0%	1 0.7%
BAS Abn. Day 360 - Nor. Day 390	1 0.7%	3 2.1%	2 1.4%	1 0.7%	1 0.7%
BAS Nor. Day 360 - Abn. Day 390	1 0.7%	1 0.7%	4 2.8%	1 0.7%	2 1.4%
BAS Nor. Day 360 - Nor. Day 390	55 38.5%	51 35.9%	50 35.5%	52 35.9%	50 35.2%
CPK Abn. Day 360 - Abn. Day 390	10 7%	0 0%	4 2.8%	3 2.1%	5 3.5%
CPK Abn. Day 360 - Nor. Day 390	5 3.5%	4 2.8%	7 5%	3 2.1%	1 0.7%
CPK Nor. Day 360 - Abn. Day 390	5 3.5%	2 1.4%	7 5%	10 6.9%	1 0.7%
CPK Nor. Day 360 - Nor. Day 390	39 27.3%	50 35.2%	38 27%	39 26.9%	46 32.4%
EOS Abn. Day 360 - Abn. Day 390	0 0%	1 0.7%	1 0.7%	3 2.1%	0 0%
EOS Abn. Day 360 - Nor. Day 390	2 1.4%	1 0.7%	1 0.7%	1 0.7%	0 0%
EOS Nor. Day 360 - Abn. Day 390	1 0.7%	3 2.1%	1 0.7%	0 0%	1 0.7%
EOS Nor. Day 360 - Nor. Day 390	56 39.2%	51 35.9%	53 37.6%	50 34.5%	53 37.3%
LYM Abn. Day 360 - Abn. Day 390	5 3.5%	2 1.4%	5 3.5%	4 2.8%	5 3.5%
LYM Abn. Day 360 - Nor. Day 390	4 2.8%	3 2.1%	3 2.1%	0 0%	2 1.4%
LYM Nor. Day 360 - Abn. Day 390	3 2.1%	3 2.1%	1 0.7%	3 2.1%	1 0.7%
LYM Nor. Day 360 - Nor. Day 390	47 32.9%	48 33.8%	47 33.3%	47 32.4%	46 32.4%
MON Abn. Day 360 - Abn. Day 390	0 0%	1 0.7%	1 0.7%	2 1.4%	0 0%
MON Abn. Day 360 - Nor. Day 390	1 0.7%	0 0%	2 1.4%	1 0.7%	1 0.7%
MON Nor. Day 360 - Abn. Day 390	2 1.4%	1 0.7%	1 0.7%	2 1.4%	0 0%
MON Nor. Day 360 - Nor. Day 390	56 39.2%	54 38%	52 36.9%	49 33.8%	53 37.3%
NEU Abn. Day 360 - Abn. Day 390	4 2.8%	0 0%	2 1.4%	2 1.4%	0 0%
NEU Abn. Day 360 - Nor. Day 390	4 2.8%	4 2.8%	3 2.1%	2 1.4%	3 2.1%
NEU Nor. Day 360 - Abn. Day 390	4 2.8%	2 1.4%	0 0%	3 2.1%	2 1.4%
NEU Nor. Day 360 - Nor. Day 390	47 32.9%	50 35.2%	51 36.2%	47 32.4%	49 34.5%
WBC Abn. Day 360 - Abn. Day 390	3 2.1%	1 0.7%	4 2.8%	1 0.7%	2 1.4%
WBC Abn. Day 360 - Nor. Day 390	6 4.2%	2 1.4%	4 2.8%	1 0.7%	3 2.1%
WBC Nor. Day 360 - Abn. Day 390	6 4.2%	2 1.4%	2 1.4%	2 1.4%	2 1.4%
WBC Nor. Day 360 - Nor. Day 390	44 30.8%	51 35.9%	46 32.6%	50 34.5%	47 33.1%

31. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase
Description	Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 60).
Time Frame	At Day 0 and up to Day 60.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	141	141	138	141	139
ALT Abn. Day 0 - Abn. Day 60	15 10.5%	10 7%	9 6.4%	6 4.1%	12 8.5%
ALT Abn. Day 0 - Nor. Day 60	1 0.7%	4 2.8%	4 2.8%	7 4.8%	5 3.5%
ALT Nor. Day 0 - Abn. Day 60	12 8.4%	5 3.5%	10 7.1%	8 5.5%	9 6.3%
ALT Nor. Day 0 - Nor. Day 60	113 79%	122 85.9%	115 81.6%	120 82.8%	113 79.6%
AST Abn. Day 0 - Abn. Day 60	4 2.8%	3 2.1%	1 0.7%	1 0.7%	3 2.1%
AST Abn. Day 0 - Nor. Day 60	0 0%	1 0.7%	2 1.4%	3 2.1%	2 1.4%
AST Nor. Day 0 - Abn. Day 60	12 8.4%	1 0.7%	7 5%	8 5.5%	6 4.2%
AST Nor. Day 0 - Nor. Day 60	125 87.4%	136 95.8%	128 90.8%	129 89%	128 90.1%
HGB Abn. Day 0 - Abn. Day 60	15 10.5%	9 6.3%	8 5.7%	11 7.6%	9 6.3%
HGB Abn. Day 0 - Nor. Day 60	4 2.8%	6 4.2%	4 2.8%	2 1.4%	4 2.8%
HGB Nor. Day 0 - Abn. Day 60	10 7%	13 9.2%	11 7.8%	9 6.2%	16 11.3%
HGB Nor. Day 0 - Nor. Day 60	112 78.3%	113 79.6%	115 81.6%	119 82.1%	110 77.5%
LDH Abn. Day 0 - Abn. Day 60	10 7%	7 4.9%	5 3.5%	2 1.4%	8 5.6%
LDH Abn. Day 0 - Nor. Day 60	1 0.7%	1 0.7%	1 0.7%	6 4.1%	1 0.7%
LDH Nor. Day 0 - Abn. Day 60	11 7.7%	9 6.3%	6 4.3%	9 6.2%	9 6.3%
LDH Nor. Day 0 - Nor. Day 60	119 83.2%	123 86.6%	126 89.4%	124 85.5%	121 85.2%
PLA Abn. Day 0 - Abn. Day 60	9 6.3%	8 5.6%	6 4.3%	8 5.5%	7 4.9%
PLA Abn. Day 0 - Nor. Day 60	1 0.7%	0 0%	0 0%	3 2.1%	1 0.7%
PLA Nor. Day 0 - Abn. Day 60	9 6.3%	11 7.7%	10 7.1%	8 5.5%	5 3.5%
PLA Nor. Day 0 - Nor. Day 60	122 85.3%	122 85.9%	122 86.5%	122 84.1%	126 88.7%
RBC Abn. Day 0 - Abn. Day 60	5 3.5%	9 6.3%	2 1.4%	2 1.4%	4 2.8%
RBC Abn. Day 0 - Nor. Day 60	2 1.4%	4 2.8%	6 4.3%	4 2.8%	5 3.5%
RBC Nor. Day 0 - Abn. Day 60	7 4.9%	12 8.5%	17 12.1%	14 9.7%	6 4.2%
RBC Nor. Day 0 - Nor. Day 60	127 88.8%	116 81.7%	113 80.1%	121 83.4%	124 87.3%
S-CREA Abn. Day 0 - Abn. Day 60	4 2.8%	3 2.1%	4 2.8%	6 4.1%	12 8.5%
S-CREA Abn. Day 0 - Nor. Day 60	1 0.7%	3 2.1%	3 2.1%	1 0.7%	3 2.1%
S-CREA Nor. Day 0 - Abn. Day 60	8 5.6%	8 5.6%	7 5%	12 8.3%	5 3.5%
S-CREA Nor. Day 0 - Nor. Day 60	128 89.5%	127 89.4%	124 87.9%	122 84.1%	119 83.8%
UREA Abn. Day 0 - Abn. Day 60	2 1.4%	2 1.4%	4 2.8%	8 5.5%	3 2.1%
UREA Abn. Day 0 - Nor. Day 60	4 2.8%	1 0.7%	5 3.5%	3 2.1%	3 2.1%
UREA Nor. Day 0 - Abn. Day 60	18 12.6%	11 7.7%	16 11.3%	14 9.7%	8 5.6%
UREA Nor. Day 0 - Nor. Day 60	117 81.8%	127 89.4%	113 80.1%	116 80%	125 88%

32. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH
Description	Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.
Time Frame	post vaccination (up to Day 360).

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	138	140	131	133	135
ALT Abn.	26 18.2%	17 12%	18 12.8%	23 15.9%	17 12%
ALT Nor.	112 78.3%	123 86.6%	113 80.1%	110 75.9%	118 83.1%
AST Abn.	11 7.7%	5 3.5%	9 6.4%	5 3.4%	9 6.3%
AST Nor.	127 88.8%	135 95.1%	122 86.5%	128 88.3%	126 88.7%
HGB Abn.	24 16.8%	13 9.2%	12 8.5%	17 11.7%	15 10.6%
HGB Nor.	114 79.7%	127 89.4%	119 84.4%	116 80%	120 84.5%
LDH Abn.	10 7%	14 9.9%	10 7.1%	4 2.8%	11 7.7%
LDH Nor.	128 89.5%	126 88.7%	121 85.8%	129 89%	124 87.3%
PLA Abn.	11 7.7%	9 6.3%	7 5%	13 9%	10 7%
PLA Nor.	127 88.8%	131 92.3%	124 87.9%	120 82.8%	125 88%
RBC Abn.	15 10.5%	20 14.1%	16 11.3%	7 4.8%	12 8.5%
RBC Nor.	123 86%	120 84.5%	115 81.6%	126 86.9%	123 86.6%
S-CREA Abn.	11 7.7%	11 7.7%	12 8.5%	9 6.2%	18 12.7%
S-CREA Nor.	127 88.8%	129 90.8%	119 84.4%	124 85.5%	117 82.4%
UREA Abn.	11 7.7%	14 9.9%	19 13.5%	17 11.7%	8 5.6%
UREA Nor.	127 88.8%	126 88.7%	112 79.4%	116 80%	127 89.4%

33. Secondary Outcome

Title	Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase
Description	Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	At Days 360 and 390.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	59	56	54	55	53
ALT Abn. Day 360 - Abn. Day 390	4 2.8%	2 1.4%	6 4.3%	3 2.1%	3 2.1%
ALT Abn. Day 360 - Nor. Day 390	3 2.1%	1 0.7%	4 2.8%	2 1.4%	1 0.7%
ALT Nor. Day 360 - Abn. Day 390	1 0.7%	2 1.4%	0 0%	5 3.4%	0 0%
ALT Nor. Day 360 - Nor. Day 390	51 35.7%	51 35.9%	46 32.6%	45 31%	49 34.5%
AST Abn. Day 360 - Abn. Day 390	2 1.4%	0 0%	1 0.7%	0 0%	0 0%
AST Abn. Day 360 - Nor. Day 390	2 1.4%	0 0%	3 2.1%	0 0%	1 0.7%
AST Nor. Day 360 - Abn. Day 390	3 2.1%	2 1.4%	1 0.7%	4 2.8%	1 0.7%
AST Nor. Day 360 - Nor. Day 390	52 36.4%	54 38%	51 36.2%	51 35.2%	51 35.9%
HGB Abn. Day 360 - Abn. Day 390	2 1.4%	2 1.4%	2 1.4%	3 2.1%	4 2.8%
HGB Abn. Day 360 - Nor. Day 390	2 1.4%	1 0.7%	0 0%	1 0.7%	1 0.7%
HGB Nor. Day 360 - Abn. Day 390	2 1.4%	0 0%	1 0.7%	2 1.4%	2 1.4%
HGB Nor. Day 360 - Nor. Day 390	53 37.1%	53 37.3%	53 37.6%	48 33.1%	47 33.1%
LDH Abn. Day 360 - Abn. Day 390	2 1.4%	1 0.7%	0 0%	0 0%	1 0.7%
LDH Abn. Day 360 - Nor. Day 390	2 1.4%	0 0%	3 2.1%	0 0%	1 0.7%
LDH Nor. Day 360 - Abn. Day 390	1 0.7%	0 0%	2 1.4%	3 2.1%	0 0%
LDH Nor. Day 360 - Nor. Day 390	54 37.8%	55 38.7%	51 36.2%	52 35.9%	51 35.9%
PLA Abn. Day 360 - Abn. Day 390	3 2.1%	0 0%	0 0%	3 2.1%	4 2.8%
PLA Abn. Day 360 - Nor. Day 390	1 0.7%	1 0.7%	2 1.4%	2 1.4%	0 0%
PLA Nor. Day 360 - Abn. Day 390	3 2.1%	0 0%	1 0.7%	1 0.7%	0 0%
PLA Nor. Day 360 - Nor. Day 390	52 36.4%	55 38.7%	53 37.6%	48 33.1%	50 35.2%
RBC Abn. Day 360 - Abn. Day 390	1 0.7%	2 1.4%	1 0.7%	1 0.7%	4 2.8%
RBC Abn. Day 360 - Nor. Day 390	1 0.7%	2 1.4%	2 1.4%	2 1.4%	0 0%
RBC Nor. Day 360 - Abn. Day 390	2 1.4%	1 0.7%	3 2.1%	3 2.1%	0 0%
RBC Nor. Day 360 - Nor. Day 390	55 38.5%	51 35.9%	50 35.5%	48 33.1%	50 35.2%
S-CREA Abn. Day 360 - Abn. Day 390	0 0%	0 0%	2 1.4%	1 0.7%	3 2.1%
S-CREA Abn. Day 360 - Nor. Day 390	0 0%	0 0%	1 0.7%	1 0.7%	1 0.7%
S-CREA Nor. Day 360 - Abn. Day 390	1 0.7%	0 0%	0 0%	3 2.1%	2 1.4%
S-CREA Nor. Day 360 - Nor. Day 390	58 40.6%	56 39.4%	53 37.6%	50 34.5%	47 33.1%
UREA Abn. Day 360 - Abn. Day 390	2 1.4%	0 0%	2 1.4%	1 0.7%	1 0.7%
UREA Abn. Day 360 - Nor. Day 390	1 0.7%	4 2.8%	5 3.5%	4 2.8%	3 2.1%
UREA Nor. Day 360 - Abn. Day 390	1 0.7%	4 2.8%	2 1.4%	0 0%	1 0.7%
UREA Nor. Day 360 - Nor. Day 390	55 38.5%	48 33.8%	47 33.3%	50 34.5%	48 33.8%

34. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination.
Description	Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination.
Time Frame	Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	142	140	138	143	139
Any Pain	134 93.7%	129 90.8%	123 87.2%	128 88.3%	70 49.3%
Grade 3 Pain	9 6.3%	5 3.5%	2 1.4%	6 4.1%	0 0%
Any Redness	71 49.7%	39 27.5%	35 24.8%	53 36.6%	23 16.2%
Redness > 50 mm	11 7.7%	2 1.4%	0 0%	0 0%	0 0%
Any Swelling	46 32.2%	36 25.4%	34 24.1%	43 29.7%	16 11.3%
Swelling > 50 mm	9 6.3%	3 2.1%	2 1.4%	2 1.4%	0 0%

35. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination.
Description	Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity.
Time Frame	Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	142	140	138	144	139
Any Fatigue	91 63.6%	76 53.5%	67 47.5%	70 48.3%	62 43.7%
Grade 3 Fatigue	5 3.5%	5 3.5%	5 3.5%	4 2.8%	3 2.1%
Related Fatigue	83 58%	67 47.2%	57 40.4%	55 37.9%	42 29.6%
Any Fever	45 31.5%	23 16.2%	24 17%	12 8.3%	17 12%
Grade 3 Fever	1 0.7%	0 0%	1 0.7%	0 0%	1 0.7%
Related Fever	42 29.4%	17 12%	17 12.1%	6 4.1%	5 3.5%
Any Gastr.	30 21%	27 19%	29 20.6%	36 24.8%	35 24.6%
Grade 3 Gastr.	2 1.4%	5 3.5%	5 3.5%	4 2.8%	7 4.9%
Related Gastr.	21 14.7%	13 9.2%	19 13.5%	20 13.8%	19 13.4%
Any Headache	90 62.9%	67 47.2%	66 46.8%	62 42.8%	59 41.5%
Grade 3 Headache	8 5.6%	6 4.2%	8 5.7%	3 2.1%	5 3.5%
Related Headache	74 51.7%	52 36.6%	46 32.6%	41 28.3%	35 24.6%
Any Malaise	60 42%	44 31%	39 27.7%	35 24.1%	28 19.7%
Grade 3 Malaise	9 6.3%	5 3.5%	4 2.8%	4 2.8%	2 1.4%
Related Malaise	53 37.1%	36 25.4%	30 21.3%	27 18.6%	16 11.3%
Any Myalgia	85 59.4%	57 40.1%	55 39%	58 40%	34 23.9%
Grade 3 Myalgia	10 7%	4 2.8%	3 2.1%	2 1.4%	2 1.4%
Related Myalgia	79 55.2%	49 34.5%	47 33.3%	50 34.5%	22 15.5%

36. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination.
Description	Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens

Outcome Measure Data

Analysis Population Description

Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	59	56	56	56	54
Any Pain	19 13.3%	19 13.4%	13 9.2%	16 11%	10 7%
Grade 3 Pain	0 0%	0 0%	1 0.7%	0 0%	0 0%
Any Redness	6 4.2%	3 2.1%	8 5.7%	6 4.1%	2 1.4%
Redness > 50 mm	1 0.7%	0 0%	0 0%	0 0%	0 0%
Any Swelling	3 2.1%	4 2.8%	2 1.4%	5 3.4%	1 0.7%
Swelling > 50 mm	1 0.7%	0 0%	0 0%	0 0%	0 0%

37. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination.
Description	Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens

Outcome Measure Data

Analysis Population Description

Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	59	56	56	56	54
Any Fatigue	15 10.5%	14 9.9%	7 5%	15 10.3%	12 8.5%
Grade 3 Fatigue	0 0%	0 0%	0 0%	0 0%	1 0.7%
Related Fatigue	15 10.5%	12 8.5%	5 3.5%	13 9%	10 7%
Any Fever	3 2.1%	1 0.7%	0 0%	3 2.1%	1 0.7%
Grade 3 Fever	0 0%	0 0%	0 0%	0 0%	0 0%
Related Fever	1 0.7%	1 0.7%	0 0%	2 1.4%	1 0.7%
Any Gastr.	4 2.8%	5 3.5%	4 2.8%	3 2.1%	5 3.5%
Grade 3 Gastr.	0 0%	0 0%	0 0%	0 0%	0 0%
Related Gastr.	4 2.8%	5 3.5%	2 1.4%	2 1.4%	3 2.1%
Any Headache	15 10.5%	7 4.9%	7 5%	8 5.5%	14 9.9%
Grade 3 Headache	0 0%	0 0%	0 0%	1 0.7%	0 0%
Related Headache	13 9.1%	5 3.5%	6 4.3%	7 4.8%	9 6.3%
Any Malaise	6 4.2%	5 3.5%	2 1.4%	4 2.8%	4 2.8%
Grade 3 Malaise	0 0%	0 0%	0 0%	0 0%	0 0%
Related Malaise	6 4.2%	4 2.8%	2 1.4%	4 2.8%	4 2.8%
Any Myalgia	4 2.8%	3 2.1%	2 1.4%	5 3.4%	1 0.7%
Grade 3 Myalgia	0 0%	0 0%	0 0%	0 0%	1 0.7%
Related Myalgia	4 2.8%	2 1.4%	2 1.4%	5 3.4%	1 0.7%

38. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination
Description	An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine.
Time Frame	Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	143	142	141	145	142
Subjects with any AE(s)	80 55.9%	73 51.4%	76 53.9%	67 46.2%	71 50%
Subjects with Grade 3 AE(s)	17 11.9%	11 7.7%	12 8.5%	19 13.1%	15 10.6%
Subjects with related AE(s)	32 22.4%	19 13.4%	27 19.1%	21 14.5%	19 13.4%
Subjects with Grade 3 and related AE(s)	7 4.9%	1 0.7%	2 1.4%	1 0.7%	2 1.4%

39. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination
Description	An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time Frame	Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens

Outcome Measure Data

Analysis Population Description

Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.

Arm/Group Title	GSK223192A 1 - HLA Subsets Group	GSK223192A 2 - HLA Subsets Group	GSK223192A 3 - HLA Subsets Group	Fendrix - HLA Subsets Group	Engerix-B - HLA Subsets Group
Arm/Group Description	This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	59	56	56	56	54
Subjects with any AE(s)	12 8.4%	8 5.6%	9 6.4%	14 9.7%	10 7%
Subjects with any grade 3 AE(s)	2 1.4%	2 1.4%	2 1.4%	4 2.8%	1 0.7%
Subjects with related AE(s)	3 2.1%	1 0.7%	0 0%	2 1.4%	2 1.4%
Subjects with Grade 3 and related AE(s)	0 0%	0 0%	0 0%	0 0%	0 0%

40. Secondary Outcome

Title	Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs)
Description	AESIs included Autoimmune Disease (AID), neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, and other autoimmune/inflammatory events. Any AESI(s) = occurrence of any AESI(s) in a subject regardless of assessment of relationship to study vaccination. Related AESI(s) = Occurrence of AESI(s) in a subject assessed by the investigator as causally related to the study vaccination.
Time Frame	During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	143	142	141	145	142
Any AESI(s)	0 0%	1 0.7%	0 0%	0 0%	0 0%
Related AESI(s)	0 0%	0 0%	0 0%	0 0%	0 0%

41. Secondary Outcome

Title	Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination
Description	A SAE was defined as a medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = occurrence of SAE(s) in a subject regardless of assessment of relationship to study vaccination. Related SAE(s) = occurrence of occurrence of SAE(s) in a subject assessed by the investigators as causally related to the study vaccination.
Time Frame	During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	143	142	141	145	142
Any SAE(s)	7 4.9%	4 2.8%	10 7.1%	7 4.8%	7 4.9%
Related SAE(s)	0 0%	0 0%	0 0%	0 0%	0 0%

42. Secondary Outcome

Title	Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)
Description	The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Tumor Necrosis Factor (TNF), Tumor Necrosis Factor Receptor Superfamily (TNFRSF9).
Time Frame	At Days 0, 1, 14, 30, 31, 33 and 37

Outcome Measure Data

Analysis Population Description

The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	18	23	28	22	21
TNF.mRNA, Day 0	1.18	1.09	1.24	1.18	1.18
TNF.mRNA, Day 1	1.33	1.08	1.1	1	1.06
TNF.mRNA, Day 14	0.95	1.07	1	1.03	1.13
TNF.mRNA, Day 30	1.03	1.21	1.25	1.19	1.09
TNF.mRNA, Day 31	1.31	1.26	1.41	1.15	1.1
TNF.mRNA, Day 33	0.99	1.04	1.12	1.18	0.97
TNF.mRNA, Day 37	0.82	1.04	1	1.07	1.06
TNFRSF9.mRNA, Day 0	1.04	1.11	1.14	1.14	1.11
TNFRSF9.mRNA, Day 1	1.14	1.14	1.24	1.24	1.01
TNFRSF9.mRNA, Day 14	0.98	1.02	1.19	1.15	1.02
TNFRSF9.mRNA, Day 30	1.06	1.02	1.08	1.03	1.14
TNFRSF9.mRNA, Day 31	1.14	1.09	1	0.97	1.07
TNFRSF9.mRNA, Day 33	0.67	0.7	0.73	1.12	1.07
TNFRSF9.mRNA, Day 37	0.77	1.01	0.91	1.01	1.14

43. Secondary Outcome

Title	mRNA Levels as Measured by qPCR
Description	The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Fas associated factor 1 (FAF1), Signal Transducer And Activator Of Transcription 1(STAT1).
Time Frame	At Days 0, 1, 14, 30, 31, 33 and 37

Outcome Measure Data

Analysis Population Description

The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	18	23	28	22	21
FAF1.mRNA, Day 0	1.08	1.02	1.06	1.06	1.07
FAF1.mRNA, Day 1	0.83	0.88	0.89	0.93	1.08
FAF1.mRNA, Day 14	1.05	1.06	0.97	1	1.01
FAF1.mRNA, Day 30	0.93	1.03	1.03	0.99	1.02
FAF1.mRNA, Day 31	0.6	0.67	0.83	0.9	1.02
FAF1.mRNA, Day 33	0.85	0.95	0.94	1.01	0.98
FAF1.mRNA, Day 37	0.93	0.97	0.97	0.97	1.07
STAT1.mRNA, Day 0	0.92	0.99	0.97	0.96	0.95
STAT1.mRNA, Day 1	2.31	2.88	1.31	0.92	0.95
STAT1.mRNA, Day 14	1.02	0.96	0.98	1.04	0.96
STAT1.mRNA, Day 30	0.96	0.88	0.96	0.89	0.96
STAT1.mRNA, Day 31	4.95	3.83	3.13	0.88	0.96
STAT1.mRNA, Day 33	2.03	1.25	1.12	1.01	1
STAT1.mRNA, Day 37	0.87	0.89	0.86	0.95	1.02

44. Secondary Outcome

Title	mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR)
Description	The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interferon Regulatory Factor 1 (IRF1), MX Dynamin-Like GTPase 1(MX1).
Time Frame	At Days 0, 1, 14, 30, 31, 33 and 37

Outcome Measure Data

Analysis Population Description

The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	18	23	28	22	21
IRF1.mRNA, Day 0	0.96	0.99	0.95	1.03	1
IRF1.mRNA, Day 1	1.51	1.59	1.24	1.08	0.95
IRF1.mRNA, Day 14	1.02	1.01	1.02	1.14	0.97
IRF1.mRNA, Day 30	1	0.93	0.92	0.96	0.99
IRF1.mRNA, Day 31	3.14	2.63	1.73	1.05	0.99
IRF1.mRNA, Day 33	1.33	1.03	0.9	1.11	1.05
IRF1.mRNA, Day 37	0.99	0.93	0.9	0.97	1
MX1.mRNA, Day 0	1	1.01	0.98	1.01	0.98
MX1.mRNA, Day 1	1.61	1.59	1.18	1.01	0.9
MX1.mRNA, Day 14	0.95	1.03	0.91	1.11	1.08
MX1.mRNA, Day 30	0.96	0.92	0.92	0.96	0.94
MX1.mRNA, Day 31	3.06	2.19	2.06	0.96	0.92
MX1.mRNA, Day 33	2.92	1.83	1.87	1.07	0.98
MX1.mRNA, Day 37	0.93	0.9	0.86	1.07	1.08

45. Secondary Outcome

Title	Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR)
Description	The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interleukin-12A (IL-12A), Marker Of Proliferation Ki-67 (MKI67).
Time Frame	At Days 0, 1, 14, 30, 31, 33 and 37

Outcome Measure Data

Analysis Population Description

The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	18	23	28	22	21
IL-12A.mRNA, Day 0	1.01	0.97	0.95	0.9	1.07
IL-12A.mRNA, Day 1	1.04	1.01	1.04	0.94	1.06
IL-12A.mRNA, Day 14	0.97	0.97	1.09	0.77	0.96
IL-12A.mRNA, Day 30	1.01	1	0.87	1.1	1.03
IL-12A.mRNA, Day 31	1.32	1.2	1.04	0.9	1.01
IL-12A.mRNA, Day 33	0.94	0.85	0.86	0.89	1.05
IL-12A.mRNA, Day 37	1.14	1.08	0.95	1.09	1.22
MKI67.mRNA, Day 0	0.91	0.89	0.98	0.83	1.03
MKI67.mRNA, Day 1	0.89	0.9	0.99	0.94	1.03
MKI67.mRNA, Day 14	1.06	1.14	1.18	0.99	1.07
MKI67.mRNA, Day 30	1	0.92	1.1	0.98	0.97
MKI67.mRNA, Day 31	0.84	0.83	0.97	0.95	1.12
MKI67.mRNA, Day 33	0.96	1.02	1.14	0.89	1.03
MKI67.mRNA, Day 37	1.52	1.56	1.38	1.06	1.08

46. Secondary Outcome

Title	Levels of mRNA as Measured by qPCR
Description	The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Chemokine Ligand 10 (CXCL10), Interleukin-1B (IL-1B).
Time Frame	At Days 0, 1, 14, 30, 31, 33 and 37

Outcome Measure Data

Analysis Population Description

The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	18	23	28	22	21
IL-1B.mRNA, Day 0	1.04	1.12	1.02	1.04	0.96
IL-1B.mRNA, Day 1	1.56	1.31	1.21	1.24	0.92
IL-1B.mRNA, Day 14	0.94	0.93	0.97	1.23	1
IL-1B.mRNA, Day 30	1.2	0.98	1.04	0.94	1.05
IL-1B.mRNA, Day 31	2.02	1.47	1.23	1.14	1.06
IL-1B.mRNA, Day 33	1.31	1.07	0.93	1.02	1.01
IL-1B.mRNA, Day 37	0.97	0.87	0.85	0.83	1.01
CXCL10.mRNA, Day 0	0.92	0.97	0.92	0.97	1.07
CXCL10.mRNA, Day 1	0.96	1.14	1.06	0.97	0.96
CXCL10.mRNA, Day 14	0.88	0.95	1.06	0.9	0.97
CXCL10.mRNA, Day 30	1.08	1.03	0.88	1.1	0.92
CXCL10.mRNA, Day 31	6.25	2.93	1.59	0.95	1.18
CXCL10.mRNA, Day 33	1.35	1.06	0.86	1.13	1.05
CXCL10.mRNA, Day 37	0.91	1.02	0.94	1.03	1.09

47. Secondary Outcome

Title	Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR
Description	The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Dual Specificity Phosphatase 1 (DUSP1).
Time Frame	At Days 0, 1, 14, 30, 31, 33 and 37

Outcome Measure Data

Analysis Population Description

The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	18	23	28	22	21
PTGS2.mRNA, Day 0	1.06	1.01	1.07	1.06	1.04
PTGS2.mRNA, Day 1	1.25	1.15	1.16	1.05	0.95
PTGS2.mRNA, Day 14	1.07	0.92	1.01	1.06	1.13
PTGS2.mRNA, Day 30	1.14	0.94	1.02	0.98	1.09
PTGS2.mRNA, Day 31	1.66	1.33	1.11	1.08	1.04
PTGS2.mRNA, Day 33	0.97	0.85	0.82	1.07	1.01
PTGS2.mRNA, Day 37	0.87	0.94	0.91	0.96	1.15
DUSP1.mRNA, Day 0	0.84	0.96	1.02	0.89	0.9
DUSP1.mRNA, Day 1	1.09	1.1	1.12	1.14	0.85
DUSP1.mRNA, Day 14	0.95	0.85	1.2	1.07	1
DUSP1.mRNA, Day 30	1.03	0.81	0.92	0.86	0.96
DUSP1.mRNA, Day 31	1.34	1.3	1.05	1.31	0.94
DUSP1.mRNA, Day 33	0.97	0.84	0.81	1.18	0.99
DUSP1.mRNA, Day 37	0.91	0.94	0.95	0.94	1

48. Secondary Outcome

Title	Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR)
Description	The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Nuclear Factor Of Activated T-Cells, Cytoplasmic, Calcineurin-Dependent 2 (NFATC2) and Interferon-gamma (IFN-γ).
Time Frame	At Days 0, 1, 14, 30, 31, 33 and 37

Outcome Measure Data

Analysis Population Description

The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.

Arm/Group Title	GSK223192A 1 Group	GSK223192A 2 Group	GSK223192A 3 Group	Fendrix Group	Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Measure Participants	18	23	28	22	21
NFATC2.mRNA, Day 0	0.98	0.94	1.03	0.93	1.11
NFATC2.mRNA, Day 1	0.66	0.73	0.83	0.83	1.04
NFATC2.mRNA, Day 14	1	0.98	1.09	0.89	1.1
NFATC2.mRNA, Day 30	0.92	0.99	1	1.05	1.08
NFATC2.mRNA, Day 31	0.46	0.58	0.78	0.87	1.1
NFATC2.mRNA, Day 33	0.79	0.9	0.87	1.05	1.05
NFATC2.mRNA, Day 37	1.03	1.03	0.98	1.16	1.11
IFN-γ.mRNA, Day 0	0.97	0.97	0.94	0.97	1.07
IFN-γ.mRNA, Day 1	0.89	1.01	1.03	0.97	0.96
IFN-γ.mRNA, Day 14	0.88	0.97	1.11	0.82	0.96
IFN-γ.mRNA, Day 30	1.08	1.03	0.88	1.13	0.92
IFN-γ.mRNA, Day 31	0.91	0.86	0.89	0.96	1.18
IFN-γ.mRNA, Day 33	0.9	0.92	0.83	1.13	1.05
IFN-γ.mRNA, Day 37	0.89	1.02	0.94	1.09	1.09

Adverse Events

Time Frame	Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2)
Adverse Event Reporting Description	Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Arm/Group Title	GSK223192A 1 Group		GSK223192A 2 Group		GSK223192A 3 Group		Fendrix Group		Engerix-B Group
Arm/Group Description	Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.		Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.		Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.		Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.		Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
All Cause Mortality
	GSK223192A 1 Group		GSK223192A 2 Group		GSK223192A 3 Group		Fendrix Group		Engerix-B Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/143 (0%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Serious Adverse Events
	GSK223192A 1 Group		GSK223192A 2 Group		GSK223192A 3 Group		Fendrix Group		Engerix-B Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/143 (4.9%)		4/142 (2.8%)		10/141 (7.1%)		7/145 (4.8%)		7/142 (4.9%)
Gastrointestinal disorders
Colitis	0/143 (0%)		0/142 (0%)		0/141 (0%)		1/145 (0.7%)		0/142 (0%)
Constipation	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Inguinal hernia	1/143 (0.7%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Diarrhoea	0/143 (0%)		0/142 (0%)		0/141 (0%)		1/145 (0.7%)		0/142 (0%)
Infections and infestations
Appendicitis	1/143 (0.7%)		1/142 (0.7%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Diverticulitis	0/143 (0%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		1/142 (0.7%)
Pharyngitis	0/143 (0%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		1/142 (0.7%)
Pyelonephritis	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Tonsillitis	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Injury, poisoning and procedural complications
Abdominal injury	0/143 (0%)		1/142 (0.7%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Epicondylitis	1/143 (0.7%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Fibula fracture	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Laceration	1/143 (0.7%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Ligament rupture	0/143 (0%)		1/142 (0.7%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Rib fracture	0/143 (0%)		1/142 (0.7%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Tibia fracture	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Investigations
Weight decreased	0/143 (0%)		1/142 (0.7%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Metabolism and nutrition disorders
Dyslipidaemia	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Type 2 diabetes mellitus	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		1/145 (0.7%)		0/142 (0%)
Musculoskeletal pain	1/143 (0.7%)		0/142 (0%)		0/141 (0%)		1/145 (0.7%)		0/142 (0%)
Chondropathy	1/143 (0.7%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Foot deformity	1/143 (0.7%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Joint effusion	0/143 (0%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		1/142 (0.7%)
Rotator cuff syndrome	0/143 (0%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		1/142 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Nervous system disorders
Cluster headache	1/143 (0.7%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Psychiatric disorders
Depression	0/143 (0%)		0/142 (0%)		0/141 (0%)		2/145 (1.4%)		1/142 (0.7%)
Acute stress disorder	0/143 (0%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		1/142 (0.7%)
Anxiety disorder	0/143 (0%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		1/142 (0.7%)
Post-traumatic stress disorder	0/143 (0%)		0/142 (0%)		0/141 (0%)		1/145 (0.7%)		0/142 (0%)
Somatisation disorder	0/143 (0%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		1/142 (0.7%)
Reproductive system and breast disorders
Cervical dysplasia	0/143 (0%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		1/142 (0.7%)
Ovarian cyst torsion	1/143 (0.7%)		0/142 (0%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Varicocele	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy	1/143 (0.7%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Asthma	0/143 (0%)		1/142 (0.7%)		0/141 (0%)		0/145 (0%)		0/142 (0%)
Paranasal cyst	0/143 (0%)		0/142 (0%)		0/141 (0%)		1/145 (0.7%)		0/142 (0%)
Vascular disorders
Hypertension	0/143 (0%)		0/142 (0%)		1/141 (0.7%)		0/145 (0%)		0/142 (0%)
Other (Not Including Serious) Adverse Events
	GSK223192A 1 Group		GSK223192A 2 Group		GSK223192A 3 Group		Fendrix Group		Engerix-B Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	137/143 (95.8%)		135/142 (95.1%)		131/141 (92.9%)		141/145 (97.2%)		114/142 (80.3%)
General disorders
Pain	134/142 (94.4%)		129/140 (92.1%)		123/138 (89.1%)		128/143 (89.5%)		70/139 (50.4%)
Redness	71/142 (50%)		39/140 (27.9%)		35/138 (25.4%)		53/143 (37.1%)		23/139 (16.5%)
Swelling	46/142 (32.4%)		36/140 (25.7%)		34/138 (24.6%)		43/143 (30.1%)		16/139 (11.5%)
Pain	19/59 (32.2%)		19/56 (33.9%)		13/56 (23.2%)		16/56 (28.6%)		10/54 (18.5%)
Redness	6/59 (10.2%)		3/56 (5.4%)		8/56 (14.3%)		6/56 (10.7%)		2/54 (3.7%)
Swelling	3/59 (5.1%)		4/56 (7.1%)		2/56 (3.6%)		5/56 (8.9%)		1/54 (1.9%)
Fatigue	91/142 (64.1%)		76/140 (54.3%)		67/138 (48.6%)		70/144 (48.6%)		62/139 (44.6%)
Fever (Oral temperature >= 37.5°C)	45/142 (31.7%)		23/140 (16.4%)		24/138 (17.4%)		12/144 (8.3%)		17/139 (12.2%)
Gastrointestinal symptoms	30/142 (21.1%)		27/140 (19.3%)		29/138 (21%)		36/144 (25%)		35/139 (25.2%)
Headache	90/142 (63.4%)		67/140 (47.9%)		66/138 (47.8%)		62/144 (43.1%)		59/139 (42.4%)
Malaise	60/142 (42.3%)		44/140 (31.4%)		39/138 (28.3%)		35/144 (24.3%)		28/139 (20.1%)
Myalgia	85/142 (59.9%)		57/140 (40.7%)		55/138 (39.9%)		58/144 (40.3%)		34/139 (24.5%)
Fatigue	15/59 (25.4%)		14/56 (25%)		7/56 (12.5%)		15/56 (26.8%)		12/54 (22.2%)
Fever (Oral temperature > = 37.5°C)	3/59 (5.1%)		1/56 (1.8%)		0/56 (0%)		3/56 (5.4%)		1/54 (1.9%)
Gastrointestinal symptoms	4/59 (6.8%)		5/56 (8.9%)		4/56 (7.1%)		3/56 (5.4%)		5/54 (9.3%)
Headache	15/59 (25.4%)		7/56 (12.5%)		7/56 (12.5%)		8/56 (14.3%)		14/54 (25.9%)
Malaise	6/59 (10.2%)		5/56 (8.9%)		2/56 (3.6%)		4/56 (7.1%)		4/54 (7.4%)
Myalgia	4/59 (6.8%)		3/56 (5.4%)		2/56 (3.6%)		5/56 (8.9%)		1/54 (1.9%)
Infections and infestations
Nasopharyngitis	11/143 (7.7%)		8/142 (5.6%)		7/141 (5%)		4/145 (2.8%)		7/142 (4.9%)
Nasopharyngitis	3/59 (5.1%)		0/56 (0%)		1/56 (1.8%)		0/56 (0%)		0/54 (0%)
Nervous system disorders
Headache	3/143 (2.1%)		2/142 (1.4%)		4/141 (2.8%)		3/145 (2.1%)		8/142 (5.6%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.