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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK223192A 1 Group | Experimental | 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. |
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| GSK223192A 2 Group | Experimental | 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. |
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| GSK223192A 3 Group | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix-Bâ„¢ | Biological | 2 doses intramuscular injections |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells . | 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. | At Day 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | 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). |
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Inclusion Criteria:
All subjects must satisfy the following criteria at study entry :
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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1200 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39206189 | Derived | Tasdighian S, Bechtold V, Essaghir A, Saeys Y, Burny W. An innate immune signature induced by AS01- or AS03-adjuvanted vaccines predicts the antibody response magnitude and quality consistently over time. Front Immunol. 2024 Aug 14;15:1412732. doi: 10.3389/fimmu.2024.1412732. eCollection 2024. | |
| 33493551 | Derived |
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fendrix Group | Experimental | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
|
| Engerix-B Group | Active Comparator | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
|
| Fendrixâ„¢ |
| Biological |
2 doses intramuscular injections |
|
| GSK Biologicals' Hepatitis B vaccines (GSK223192A) | Biological | 2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group |
|
| HBsAg (Booster injection) | Biological | Single dose intramuscular injection |
|
| At Days 0, 14, 30 and 60 |
| Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | 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). | At Days 0, 14, 30, 44, and 60 |
| Number of HB Specific CD4+ T Cells . | 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). | At Days 0, 180 and 360 |
| Number of HB - Specific CD8+ T Cells. | 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). | At Days 0, 180 and 360 |
| Number of HB - Specific CD4+ T Cells. | 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). | At Days 0, 360 and 374 |
| Number of HB - Specific CD8+ T Cells | 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). | At Days 0, 360 and 374 |
| Number of HB - Specific CD4+ T Cells | 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. | At Days 0, 14, 30, 33, 37, 44 and 60 |
| Number of HB - Specific CD8+ T Cells | 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. | At Days 0, 14, 30, 44, 60 and 180 |
| 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 | 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). | At Days 0, 14, 30, 44 and 60 |
| Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | 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). | At Days 0 and 180 |
| Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | 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. | At Days 0, 30, 44, and 60 |
| Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | 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. | At Days 0, 180 and 360 |
| Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | 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. | At Days 0, 374 and 390 |
| Number of Hepatitis B (HB)-Specific Memory B Cells | 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. | At Days 0, 30, 37, 44 and 60. |
| Number of HB-specific Memory B Cells | 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. | At Days 180 and 360 |
| 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 | 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. | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37. |
| Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | 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. | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60. |
| Normalized Levels of C-reactive Protein (CRP) | 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. | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37. |
| Normalized Levels of WBC and of CPK | 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. | At Days 0, 30, 37 and 60. |
| Normalized Levels of CRP | 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. | At Days 0, 30 and 37. |
| Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | 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. | 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 WBC, NEU, LYM, MON, EOS and BAS | 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. | At Days 0, 30, 37 and 60. |
| Normalized Levels of Red Blood Cells and Platelets | 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). | At Days 0, 30, 37 and 60. |
| Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | 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). | At Days 0, 30, 37 and 60. |
| Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | 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). | At Days 0, 30, 37 and 60. |
| Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | 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. | At Day 0 and up to Day 60. |
| Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | 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. | At Day 0 and up to Day 60. |
| Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | 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. | Post vaccination (up to Day 360) |
| Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | 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. | At Days 360 and 390. |
| Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | 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). | At Day 0 and up to Day 60. |
| Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | 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. | post vaccination (up to Day 360). |
| Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | 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. | At Days 360 and 390. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | 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. | Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccines. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | 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. | Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | 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. | Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | 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. | Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens |
| Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | 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. | Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine |
| Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | 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. | Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens |
| Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | 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. | 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. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | 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. | 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. |
| Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | 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). | At Days 0, 1, 14, 30, 31, 33 and 37 |
| mRNA Levels as Measured by qPCR | 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). | At Days 0, 1, 14, 30, 31, 33 and 37 |
| mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | 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). | At Days 0, 1, 14, 30, 31, 33 and 37 |
| Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | 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). | At Days 0, 1, 14, 30, 31, 33 and 37 |
| Levels of mRNA as Measured by qPCR | 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). | At Days 0, 1, 14, 30, 31, 33 and 37 |
| Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | 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). | At Days 0, 1, 14, 30, 31, 33 and 37 |
| Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | 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). | At Days 0, 1, 14, 30, 31, 33 and 37 |
| Ghent |
| 9000 |
| Belgium |
| GSK Investigational Site | La Louvière | 7100 | Belgium |
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
| GSK Investigational Site | Tübingen | Baden-Wurttemberg | 72074 | Germany |
| GSK Investigational Site | Haag | Bavaria | 83527 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80636 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Regensburg | Bavaria | 93053 | Germany |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Berlin | 12627 | Germany |
| GSK Investigational Site | Berlin | 13125 | Germany |
| GSK Investigational Site | Hamburg | 20253 | Germany |
| Moris P, Bellanger A, Ofori-Anyinam O, Jongert E, Yarzabal Rodriguez JP, Janssens M. Whole blood can be used as an alternative to isolated peripheral blood mononuclear cells to measure in vitro specific T-cell responses in human samples. J Immunol Methods. 2021 May;492:112940. doi: 10.1016/j.jim.2020.112940. Epub 2021 Jan 23. |
| 33177181 | Derived | De Mot L, Bechtold V, Bol V, Callegaro A, Coccia M, Essaghir A, Hasdemir D, Ulloa-Montoya F, Siena E, Smilde A, van den Berg RA, Didierlaurent AM, Burny W, van der Most RG. Transcriptional profiles of adjuvanted hepatitis B vaccines display variable interindividual homogeneity but a shared core signature. Sci Transl Med. 2020 Nov 11;12(569):eaay8618. doi: 10.1126/scitranslmed.aay8618. |
| 32677968 | Derived | Hasdemir D, van den Berg RA, van Kampen A, Smilde AK. Modeling adaptive response profiles in a vaccine clinical trial. BMC Med Res Methodol. 2020 Jul 16;20(1):191. doi: 10.1186/s12874-020-01070-3. |
| 30850240 | Derived | Burny W, Marchant A, Herve C, Callegaro A, Caubet M, Fissette L, Gheyle L, Legrand C, Ndour C, Tavares Da Silva F, van der Most R, Willems F, Didierlaurent AM, Yarzabal J; ECR-008 study group. Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans. Vaccine. 2019 Mar 28;37(14):2004-2015. doi: 10.1016/j.vaccine.2019.02.015. Epub 2019 Mar 5. |
| 28855902 | Derived | Burny W, Callegaro A, Bechtold V, Clement F, Delhaye S, Fissette L, Janssens M, Leroux-Roels G, Marchant A, van den Berg RA, Garcon N, van der Most R, Didierlaurent AM; ECR-002 Study Group. Different Adjuvants Induce Common Innate Pathways That Are Associated with Enhanced Adaptive Responses against a Model Antigen in Humans. Front Immunol. 2017 Aug 14;8:943. doi: 10.3389/fimmu.2017.00943. eCollection 2017. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| FG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| BG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | White - Caucasian / European heritage | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells . | 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. | 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. | Posted | Median | Inter-Quartile Range | HB-CD4+ T cells (per million cells) | At Day 44 |
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| Secondary | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | 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). | 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. | Posted | Median | Inter-Quartile Range | HB-CD4+ T cells (per million cells) | At Days 0, 14, 30 and 60 |
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| Secondary | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | 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). | 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. | Posted | Median | Inter-Quartile Range | HB-CD8+ T cells (per million cells) | At Days 0, 14, 30, 44, and 60 |
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| Secondary | Number of HB Specific CD4+ T Cells . | 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). | 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). | Posted | Median | Inter-Quartile Range | HB-CD4+ T cells (per million cells) | At Days 0, 180 and 360 |
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| Secondary | Number of HB - Specific CD8+ T Cells. | 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). | 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). | Posted | Median | Inter-Quartile Range | HB-CD8+ T cells (per million cells) | At Days 0, 180 and 360 |
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| Secondary | Number of HB - Specific CD4+ T Cells. | 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). | 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. | Posted | Median | Inter-Quartile Range | HB-CD4+ T cells (per million cells) | At Days 0, 360 and 374 |
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| Secondary | Number of HB - Specific CD8+ T Cells | 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). | 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. | Posted | Median | Inter-Quartile Range | HB-CD8+ T cells (per million cells) | At Days 0, 360 and 374 |
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| Secondary | Number of HB - Specific CD4+ T Cells | 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. | 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. | Posted | Median | Inter-Quartile Range | HB-CD4+ T cells (per million cells) | At Days 0, 14, 30, 33, 37, 44 and 60 |
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| Secondary | Number of HB - Specific CD8+ T Cells | 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. | 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. | Posted | Median | Inter-Quartile Range | HB-CD8+ T cells (per million cells) | At Days 0, 14, 30, 44, 60 and 180 |
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| Secondary | 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 | 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). | 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. | Posted | Median | Inter-Quartile Range | HB-CD4+ T cells (per million cells) | At Days 0, 14, 30, 44 and 60 |
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| Secondary | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | 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). | 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). | Posted | Median | Inter-Quartile Range | HB-CD4+ T cells (per million cells) | At Days 0 and 180 |
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| Secondary | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Days 0, 30, 44, and 60 |
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| Secondary | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | 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. | 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). | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Days 0, 180 and 360 |
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| Secondary | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Days 0, 374 and 390 |
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| Secondary | Number of Hepatitis B (HB)-Specific Memory B Cells | 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. | 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. | Posted | Median | Inter-Quartile Range | HB mem-B cells (per million cells) | At Days 0, 30, 37, 44 and 60. |
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| Secondary | Number of HB-specific Memory B Cells | 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. | 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). | Posted | Median | Inter-Quartile Range | HB mem-B cells (per million cells) | At Days 180 and 360 |
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| Secondary | 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 | 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. | 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. | Posted | Median | Inter-Quartile Range | pg/mL | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37. |
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| Secondary | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | 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. | 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. | Posted | Median | Inter-Quartile Range | IH Center normalized ratio | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60. |
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| Secondary | Normalized Levels of C-reactive Protein (CRP) | 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. | 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. | Posted | Median | Inter-Quartile Range | IH Center normlized ratio | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37. |
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| Secondary | Normalized Levels of WBC and of CPK | 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. | 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. | Posted | Median | Inter-Quartile Range | IH Center normalized ratio | At Days 0, 30, 37 and 60. |
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| Secondary | Normalized Levels of CRP | 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. | 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. | Posted | Median | Inter-Quartile Range | IH Center normalized levels | At Days 0, 30 and 37. |
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| Secondary | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | 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. | 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. | Posted | Median | Inter-Quartile Range | IH normalized ratio | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60. |
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| Secondary | Levels of WBC, NEU, LYM, MON, EOS and BAS | 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. | 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. | Posted | Median | Inter-Quartile Range | IH normalized ratio | At Days 0, 30, 37 and 60. |
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| Secondary | Normalized Levels of Red Blood Cells and Platelets | 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). | 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. | Posted | Median | Inter-Quartile Range | cells/mL | At Days 0, 30, 37 and 60. |
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| Secondary | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | 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). | 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. | Posted | Median | Inter-Quartile Range | cells/mL | At Days 0, 30, 37 and 60. |
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| Secondary | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | 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). | 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. | Posted | Median | Inter-Quartile Range | cells/mL | At Days 0, 30, 37 and 60. |
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| Secondary | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | 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. | 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. | Posted | Count of Participants | Participants | At Day 0 and up to Day 60. |
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| Secondary | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | 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. | 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. | Posted | Count of Participants | Participants | At Day 0 and up to Day 60. |
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| Secondary | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | 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. | 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. | Posted | Number | Subjects | Post vaccination (up to Day 360) |
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| Secondary | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | 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. | 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. | Posted | Count of Participants | Participants | At Days 360 and 390. |
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| Secondary | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | 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). | 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. | Posted | Count of Participants | Participants | At Day 0 and up to Day 60. |
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| Secondary | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | 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. | 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. | Posted | Count of Participants | Participants | post vaccination (up to Day 360). |
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| Secondary | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | 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. | 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. | Posted | Count of Participants | Participants | At Days 360 and 390. |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | 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. | 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. | Posted | Count of Participants | Participants | Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccines. |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | 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. | 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. | Posted | Count of Participants | Participants | Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine. |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | 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. | 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. | Posted | Count of Participants | Participants | Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | 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. | 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. | Posted | Count of Participants | Participants | Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | 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. | Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | 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. | 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. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens |
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| Secondary | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | 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. | Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | 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. |
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| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | 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. | Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | 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. |
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| Secondary | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | 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). | 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. | Posted | Median | Full Range | copies | At Days 0, 1, 14, 30, 31, 33 and 37 |
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| Secondary | mRNA Levels as Measured by qPCR | 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). | 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. | Posted | Median | Full Range | copies | At Days 0, 1, 14, 30, 31, 33 and 37 |
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| Secondary | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | 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). | 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. | Posted | Median | Full Range | copies | At Days 0, 1, 14, 30, 31, 33 and 37 |
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| Secondary | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | 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). | 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. | Posted | Median | Full Range | copies | At Days 0, 1, 14, 30, 31, 33 and 37 |
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| Secondary | Levels of mRNA as Measured by qPCR | 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). | 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. | Posted | Median | Full Range | copies | At Days 0, 1, 14, 30, 31, 33 and 37 |
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| Secondary | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | 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). | 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. | Posted | Median | Full Range | copies | At Days 0, 1, 14, 30, 31, 33 and 37 |
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| Secondary | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | 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). | 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. | Posted | Median | Full Range | copies | At Days 0, 1, 14, 30, 31, 33 and 37 |
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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)
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 143 | 7 | 143 | 137 | 143 |
| EG001 | 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. | 0 | 142 | 4 | 142 | 135 | 142 |
| EG002 | 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. | 0 | 141 | 10 | 141 | 131 | 141 |
| EG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. | 0 | 145 | 7 | 145 | 141 | 145 |
| EG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. | 0 | 142 | 7 | 142 | 114 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Acute stress disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA |
| ||
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Cluster headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Ovarian cyst torsion | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Somatisation disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Varicocele | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment | Unsolicited AE reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment | Unsolicited AE reported post vaccination with HBsAg antigens. |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment | Unsolicited AE reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine. |
|
| Pain | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine. |
|
| Redness | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine. |
|
| Swelling | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine. |
|
| Pain | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with HBsAg antigens. |
|
| Redness | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with HBsAg antigens. |
|
| Swelling | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with HBsAg antigens. |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine. |
|
| Fever (Oral temperature >= 37.5°C) | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine. |
|
| Gastrointestinal symptoms | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine. |
|
| Headache | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine. |
|
| Malaise | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine. |
|
| Myalgia | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with the GSK223192A, Fendrixâ„¢ or Engerix-Bâ„¢ vaccine. |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with HBsAg antigens. |
|
| Fever (Oral temperature > = 37.5°C) | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with HBsAg antigens. |
|
| Gastrointestinal symptoms | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with HBsAg antigens. |
|
| Headache | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with HBsAg antigens. |
|
| Malaise | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with HBsAg antigens. |
|
| Myalgia | General disorders | MedDRA | Systematic Assessment | Solicited symptom reported post vaccination with HBsAg antigens. |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C075654 | Engerix-B |
| C515207 | Fendrix |
| D006514 | Hepatitis B Surface Antigens |
| D007117 | Immunization, Secondary |
| ID | Term |
|---|---|
| D006511 | Hepatitis B Antigens |
| D018963 | Hepatitis Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
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.
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
|
|
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
|
|
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
|
|
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
|
|
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
|
|
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ 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.
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ 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.
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
|
|
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | GSK223192A 2 - HLA Subsets Group | 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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | GSK223192A 2 - HLA Subsets Group | 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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | GSK223192A 2 - HLA Subsets Group | 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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | GSK223192A 2 - HLA Subsets Group | 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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | GSK223192A 2 - HLA Subsets Group | 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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 |
| GSK223192A 2 - HLA Subsets Group |
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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | GSK223192A 3 - Non-HLA Subsets Group | 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. |
| OG003 | Fendrix - Non-HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30. The Fendrixâ„¢ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - Non-HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30. The Engerix-Bâ„¢ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | GSK223192A 3 - Non-HLA Subsets Group | 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. |
| OG003 | Fendrix - Non-HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30. The Fendrixâ„¢ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - Non-HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30. The Engerix-Bâ„¢ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | GSK223192A 2 - HLA Subsets Group | 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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | GSK223192A 3 - Non-HLA Subsets Group | 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. |
| OG003 | Fendrix - Non-HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30. The Fendrixâ„¢ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - Non-HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30. The Engerix-Bâ„¢ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| 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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | GSK223192A 3 - Non-HLA Subsets Group | 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. |
| OG003 | Fendrix - Non-HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30. The Fendrixâ„¢ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - Non-HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30. The Engerix-Bâ„¢ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 |
| GSK223192A 2 - HLA Subsets Group |
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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | GSK223192A 2 - HLA Subsets Group | 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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG001 | GSK223192A 2 - HLA Subsets Group | 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. |
| OG002 | GSK223192A 3 - HLA Subsets Group | 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. |
| OG003 | Fendrix - HLA Subsets Group | 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 Fendrixâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B - HLA Subsets Group | 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-Bâ„¢, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ 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. |
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ 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.
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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|
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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|
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.
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ 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.
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ 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.
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ 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.
| OG002 | 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. |
| OG003 | Fendrix Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrixâ„¢ 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 Fendrixâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| OG004 | Engerix-B Group | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-Bâ„¢ 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-Bâ„¢ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
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