| Primary | Concentrations of Cytokines and Chemokines - Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | At Day -30 prior to placebo administration | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| | | Title | Denominators | Categories |
|---|
| E-selectin | | | Title | Measurements |
|---|
| - OG0006000(4600 to 8300)
- OG0016250(4600 to 7800)
|
| | GM-CSF | | |
| |
| Primary | Cytokines and Chemokines Concentrations - Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -30 plus 1.5 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Cytokines and Chemokines in Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -30 plus 3 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Cytokines and Chemokines During Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -30 plus 6 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Cytokines/Chemokines - Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -30 plus 9 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Cytokines/Chemokines in Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -30 plus 12 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Cytokines/Chemokines During Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -30 plus 18 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines and Chemokines Concentrations in Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -29 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines and Chemokines Concetrations During Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -28 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines/Chemokines Concentrations in Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -27 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines and Chemokines Concentrations During Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-placebo at Day -23 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Cytokines and Chemokines - Study Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Pre-dose1 at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Cytokines and Chemokines in Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose1 at Day 0 plus 1.5 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Cytokines and Chemokines During Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose1 at Day 0 plus 6 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines and Chemokines Concentrations - Study Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose1 at Day 0 plus 12 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines and Chemokines Concentrations in Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose1 at Day 0 plus 18 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines and Chemokines Concentrations During Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose1 at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines/Chemokines Concentrations - Study Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose1 at Day 2 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines/Chemokines Concentrations in Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose1 at Day 7 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Cytokines/Chemokines Concentrations During Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose1 at Day 30 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Plasma Concentrations of Cytokines and Chemokines - Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 30 plus 1.5 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 30 plus 3 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 30 plus 6 hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 30 plus 9 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 30 plus 12 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 30 plus 18 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 31 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Plasma Cytokines and Chemokines - Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 32 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Primary | Concentrations of Plasma Cytokines and Chemokines in Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 33 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Primary | Concentrations of Plasma Cytokines and Chemokines During Step 1 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 37 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Primary | Concentrations of Cytokines and Chemokines - Step 2 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point. | Posted | | Median | Inter-Quartile Range | pg/mL | | Pre-dose 1 at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Primary | Cytokines and Chemokines Concentrations - Step 2 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS_2 Group. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point. | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 1 at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm |
| |
| Primary | Concentrations of Cytokines and Chemokines During Step 2 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS_2 Group. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point. | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 1 at Day 30 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm |
| |
| Primary | Concentrations of Cytokines and Chemokines in Step 2 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS_2 Group. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point. | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose2 at Day 30 plus 6 Hours | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm |
| |
| Primary | Concentrations of Cytokines/Chemokines - Step 2 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS_2 Group. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point. | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 31 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm |
| |
| Primary | Concentrations of Cytokines/Chemokines in Step 2 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS_2 Group. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point. | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 37 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm |
| |
| Primary | Concentrations of Cytokines/Chemokines During Step 2 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B_2 Group. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point. | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 2 at Day 180 | | | | ID | Title | Description |
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| OG000 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| |
| Primary | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.The analysis was performed only on theEngerix-B_2 Group. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point. | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 3 at Day 180 plus 6 Hours | | | | ID | Title | Description |
|---|
| OG000 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Primary | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B_2 Group. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point. | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 3 at Day 181 | | | | ID | Title | Description |
|---|
| OG000 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| |
| Primary | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B_2 Group. | The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | pg/mL | | Post-dose 3 at Day 187 | | | | ID | Title | Description |
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| OG000 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1 | Anti-HBs antibody concentrations in serum were measured by Chemi Luminiscence Immuno Assay (CLIA). Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). | The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60). | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Day 0 (PRE) and Day 60 (D60) post-vaccination | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhoea and /or abdominal pain], headache, malaise, myalgia, shivering and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Assessed solicited symptoms were fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], pain, redness [spreading beyond 20 millimeters (mm) of injection site], induration [spreading beyond 20 millimeters (mm) of injection site], swelling [spreading beyond 20 millimeters (mm) of injection site] and muscle stiffness. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Up to 4 days post-placebo/vaccine administration. | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1 | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period. | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) - Step 1 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1 | PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1 | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L). ALT levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | U/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L). AST levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | U/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Basophils in Blood Samples - Step 1 | Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L). Basophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Total Bilirubin in Blood Samples - Step 1 | Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL). Bilirubin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Serum Creatinine in Blood Samples - Step 1 | Biochemical laboratory parameters assessed included creatinine levels. Creatinine concentrations were expressed in milligrams per deciliter (mg/dL). Creatinine levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | Biochemical laboratory parameters assessed included CPK levels. CPK concentrations were expressed in milligrams per deciliter (mg/dL). CPK levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L). CRP levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Eosinophils in Blood Samples - Step 1 | Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L). Eosinophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Haemoglobin in Blood Samples - Step 1 | Haematological laboratory parameters assessed included haemoglobin levels, expressed in grams per deciliter (g/dL). Haemoglobin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | g/dL | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | Biochemical laboratory parameters assessed included LDH levels, expressed in units per liter (U/L). LDH levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | U/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Lymphocytes in Blood Samples - Step 1 | Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L). Lymphocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Monocytes in Blood Samples - Step 1 | Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L). Monocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Neutrophils in Blood Samples - Step 1 | Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L). Neutrophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Platelet Count in Blood Samples - Step 1 | Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L). Platelet count levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm |
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| Secondary | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | Haematological laboratory parameters assessed included red blood cells levels, expressed in trillion cells per liter (trillion cells/L). RBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | trillion cells/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Urea in Blood Samples - Step 1 | Biochemical laboratory parameters assessed included urea levels, expressed in miligrams per deciliter (mg/dL). Urea levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of White Blood Cells (WBC) - Step 1 | Haematological laboratory parameters assessed included WBC levels. WBC levels were expressed in billion cells per liter (billion cells/L). WBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Diastolic Blood Pressure - Step 1 | Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, diastolic blood pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mmHg | | At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60 | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Heart Rate - Step 1 | Heart rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed in beats per minute. On Days -30, 0 and 30, heart rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | beats/minute | | At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Respiratory Rate - Step 1 | Respiratory Rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed as breaths per minute (breaths/min). On Days -30, 0 and 30, respiratory rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | breaths/min | | At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Systolic Pressure - Step 1 | Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, systolic pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mmHg | | At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60 | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm |
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| Secondary | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno | 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). | Analyses were performed on the According-To-Protocol (ATP) cohort for adaptive immunogenicity up to 30 days (step 2 only) post last vaccination, which included all evaluable subjects, who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group) | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence | 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). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 2 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180 for the HBsAg/AS_2 Group and at Day 330 for the Engerix-B_2 Group. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group) | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise, myalgia, shivering and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. At Day 0 of dose 2, two temperatures were collected: one at Hour 0 (H0) and a second one at Hour 18 (H18). The highest temperature between H0 et H18 was taken. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise, myalgia, shivering and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. There was no pooling for temperature symptom between Step 1 and Step 2 due to difference in recording approach for the 18 hour data (nurse or self-assessment). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2 | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 28-day (Days 0-27) and post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 28-day (Days 0-27) post-vaccination period. | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) - Step 2 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| |
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| |
| Secondary | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2 | PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented | Posted | | Count of Participants | | Participants | | Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| |
| Secondary | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step | PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| |
| Secondary | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2 | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| |
| Secondary | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Secondary | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | U/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | U/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Basophils in Blood Samples - Step 2 | Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Eosinophils in Blood Samples - Step 2 | Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | Haematological laboratory parameters assessed included white blood cells levels. WBC levels were expressed in billion cells per liter (billion cells/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Lymphocytes in Blood Samples - Step 2 | Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Monocytes in Blood Samples - Step 2 | Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Neutrophils in Blood Samples - Step 2 | Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Platelet Count in Blood Samples - Step 2 | Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | billion cells/L | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Total Bilirubin in Blood Samples - Step 2 | Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Diastolic Blood Pressure - Step 2 | Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, diastolic blood pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mmHg | | At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Levels of Heart Rate - Step 2 | Heart rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed in beats per minute. On Days 30 and 180, heart rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | beats/minute | | At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| |
| Secondary | Levels of Respiratory Rate - Step 2 | Respiratory Rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed as breaths per minute (breaths/min). On Days 30 and 180, respiratory rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | breaths/min | | At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
| |
| Secondary | Levels of Systolic Pressure - Step 2 | Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, systolic pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mmHg | | At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | -Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs). | The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | T cells/million cells | | At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination | | | | ID | Title | Description |
|---|
| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢- B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
|
| Secondary | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180. | Posted | | Median | Inter-Quartile Range | T cells/ million cells | | At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the nondominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢- B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluste of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs). | The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60). | Posted | | Median | Inter-Quartile Range | T cells/ million cells | | At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢- B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180. | Posted | | Median | Inter-Quartile Range | T ceclls/ million cells | | At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_1 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerixâ„¢- B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Assessed solicited symptoms were fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], pain, redness [spreading beyond 20 millimeters (mm) of injection site], induration [spreading beyond 20 millimeters (mm) of injection site], swelling [spreading beyond 20 millimeters (mm) of injection site] and muscle stiffness. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Up to 3 days post-placebo/vaccine administration. | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_2 Group | Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. | | OG001 | Engerix-B_2 Group | Subjects received, during Step 2 of the study, 3 doses of Engerixâ„¢-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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| Secondary | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step | Assessed solicited symptoms were fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], pain, redness [spreading beyond 20 millimeters (mm) of injection site], induration [spreading beyond 20 millimeters (mm) of injection site], swelling [spreading beyond 20 millimeters (mm) of injection site] and muscle stiffness. | The analysis was performed on the Total Vaccinated cohort, of the HBsAg/AS_1+2 Group only, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Up to 3 days post-Dose 2 vaccine administration in HBsAg/AS_1+2 Group | | | | ID | Title | Description |
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| OG000 | HBsAg/AS_1+2 Group | Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm. |
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