Hepatitis B
Conditions
Keywords
Adults, Reactogenicity, Naive, Immune responses, Read-outs, Hepatitis B, Healthy
Brief summary
This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines. This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.
Detailed description
This study will be conducted in 2 steps with 2 study groups in each step. The entire study period for Step 1 is from Day -30 to Day 210 (240 days) The entire study period for Step 2 is from Day 0 to Day 180 for Group C and from Day 0 to Day 330 for Group D. Subjects will be blinded up to Day 60 in Step 1 and will be unblinded at the end of their Day 60 visit. Step 2 will be conducted in an open-label manner.
Interventions
BIOLOGICALAdjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
BIOLOGICALEngerixTM-B
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
BIOLOGICALPlacebo
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Sponsors
Region of Wallonia
Public Private Partnership with Institute for Medical Immunology (Universite Libre de Bruxelles)
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol * A male or female between, and including, 18 and 45 years of age at the time of first study product administration * Written informed consent obtained from the subject * Healthy subjects, in the opinion of the investigator, as established by medical history, clinical examination, and clinical laboratory assessment with no active disease that could interfere with the study endpoints, before entering into the study * Body Mass Index (BMI) between 18.5 and 30 kg/m2 * Female subjects of non-childbearing potential may be enrolled in the study \- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to first study product administration and * has a negative pregnancy test on the day of placebo administration/ vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study.
Exclusion criteria
* Known history of HBV infection. * Previous vaccination against hepatitis B. * Positive for anti-hepatitis B surface (HBs) antibodies, anti-hepatitis B core (HBc) antibodies, HBsAg, HCV antibodies and/or HIV. * Any previous administration of vaccine components. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first study product administration, or planned use during the study period. * No significant dietary restrictions or life-threatening food allergies. * Regular use of non steroidal anti-inflammatory drugs within 1 month prior to first study product administration. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first study product administration.. Inhaled and topical steroids are allowed. * Planned administration / administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study product administration and during the entire study period (both Steps), with the exception of the influenza vaccine (pandemic or seasonal) which can be administered \> 21 days preceding or \> 21 days following each placebo/vaccine administration. * Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first study product administration or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV based on screening evaluations and on medical history and physical examination. * History of or current bleeding or coagulation disorder. * Any known or clinical signs of anaemia or any clinical condition (including vascular disorder) that would preclude frequent blood drawings. * Poor venous access as assessed at screening by the investigator. * Blood loss, including blood donation, of more than 300 mL within 90 days before the first study product administration. * History of or current autoimmune or other immune-mediated disease. * Any haematological or biochemical level out of normal range before entering into the study, as follows: * Haemoglobin level \< lower normal limit (LNL). * Platelet counts out of normal range. * Alanine aminotransferase \[ALT\] \> upper normal limit (UNL). * Aspartate aminotransferase \[AST\] \> UNL. * Creatinine \> UNL. * c-reactive protein \[CRP\] \> UNL. * Creatine phosphokinase \[CPK\] \> UNL without any plausible explanation for this abnormality (such as sport activity). In case of haematological and/or biochemical value out of range for parameters mentioned here above, one re-testing of out of range value may be performed. * Any acute or chronic, clinically significant disease, as determined by medical history, physical examination or laboratory screening tests. * Known or suspected reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Acute disease and/or fever at the time of enrolment. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. * Fever is defined as temperature ≥ 37.5°C for oral route. * Pregnant or lactating female. * Recent history of chronic alcohol consumption and/or drug abuse. * Other conditions that the principal investigator judges may interfere with study findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of Cytokines and Chemokines - Step 1 | At Day -30 prior to placebo administration | 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. |
| Cytokines and Chemokines Concentrations - Step 1 | Post-placebo at Day -30 plus 1.5 Hours | 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. |
| Concentrations of Cytokines and Chemokines in Step 1 | Post-placebo at Day -30 plus 3 Hours | 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. |
| Concentrations of Cytokines and Chemokines During Step 1 | Post-placebo at Day -30 plus 6 Hours | 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. |
| Concentrations of Cytokines/Chemokines - Step 1 | Post-placebo at Day -30 plus 9 Hours | 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. |
| Concentrations of Cytokines/Chemokines in Step 1 | Post-placebo at Day -30 plus 12 Hours | 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. |
| Concentrations of Cytokines/Chemokines During Step 1 | Post-placebo at Day -30 plus 18 Hours | 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. |
| Cytokines and Chemokines Concentrations in Step 1 | Post-placebo at Day -29 | 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. |
| Cytokines and Chemokines Concetrations During Step 1 | Post-placebo at Day -28 | 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. |
| Cytokines/Chemokines Concentrations in Step 1 | Post-placebo at Day -27 | 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. |
| Cytokines and Chemokines Concentrations During Step 1 | Post-placebo at Day -23 | 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. |
| Concentrations of Cytokines and Chemokines - Study Step 1 | Pre-dose1 at Day 0 | 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. |
| Concentrations of Cytokines and Chemokines in Step 1 of Study | Post-dose1 at Day 0 plus 1.5 Hours | 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. |
| Concentrations of Cytokines and Chemokines During Step 1 of Study | Post-dose1 at Day 0 plus 6 Hours | 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. |
| Cytokines and Chemokines Concentrations - Study Step 1 | Post-dose1 at Day 0 plus 12 Hours | 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. |
| Cytokines and Chemokines Concentrations in Step 1 of Study | Post-dose1 at Day 0 plus 18 Hours | 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. |
| Cytokines and Chemokines Concentrations During Step 1 of Study | Post-dose1 at Day 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. |
| Cytokines/Chemokines Concentrations - Study Step 1 | Post-dose1 at Day 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. |
| Cytokines/Chemokines Concentrations in Step 1 of Study | Post-dose1 at Day 7 | 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. |
| Cytokines/Chemokines Concentrations During Step 1 of Study | Post-dose1 at Day 30 | 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. |
| Plasma Concentrations of Cytokines and Chemokines - Step 1 | Post-dose 2 at Day 30 plus 1.5 Hours | 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. |
| Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | Post-dose 2 at Day 30 plus 3 Hours | 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. |
| Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | Post-dose 2 at Day 30 plus 6 hours | 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. |
| Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | Post-dose 2 at Day 30 plus 9 Hours | 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. |
| Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | Post-dose 2 at Day 30 plus 12 Hours | 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. |
| Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | Post-dose 2 at Day 30 plus 18 Hours | 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. |
| Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | Post-dose 2 at Day 31 | 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. |
| Concentrations of Plasma Cytokines and Chemokines - Step 1 | Post-dose 2 at Day 32 | 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. |
| Concentrations of Plasma Cytokines and Chemokines in Step 1 | Post-dose 2 at Day 33 | 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. |
| Concentrations of Plasma Cytokines and Chemokines During Step 1 | Post-dose 2 at Day 37 | 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. |
| Concentrations of Cytokines and Chemokines - Step 2 | Pre-dose 1 at Day 0 | 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. |
| Cytokines and Chemokines Concentrations - Step 2 | Post-dose 1 at Day 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 only on the HBsAg/AS\_2 Group. |
| Concentrations of Cytokines and Chemokines During Step 2 | Post-dose 1 at Day 30 | 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. |
| Concentrations of Cytokines and Chemokines in Step 2 | Post-dose2 at Day 30 plus 6 Hours | 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. |
| Concentrations of Cytokines/Chemokines - Step 2 | Post-dose 2 at Day 31 | 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. |
| Concentrations of Cytokines/Chemokines in Step 2 | Post-dose 2 at Day 37 | 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. |
| Concentrations of Cytokines/Chemokines During Step 2 | Post-dose 2 at Day 180 | 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. |
| Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | Post-dose 3 at Day 180 plus 6 Hours | 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. |
| Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | Post-dose 3 at Day 181 | 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. |
| Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | Post-dose 3 at Day 187 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1 | At Day 0 (PRE) and Day 60 (D60) post-vaccination | 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). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses | 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses | 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 |
| Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Up to 4 days post-placebo/vaccine administration. | 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. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1 | Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period. | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) - Step 1 | 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 | 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. |
| Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1 | 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 | 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. |
| Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1 | 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 | 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. |
| Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | 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 | 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. |
| Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | 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 | 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. |
| Levels of Basophils in Blood Samples - Step 1 | 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 | 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. |
| Levels of Total Bilirubin in Blood Samples - Step 1 | 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 | 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. |
| Levels of Serum Creatinine in Blood Samples - Step 1 | 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 | 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. |
| Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | 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 | 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. |
| Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | 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 | 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. |
| Levels of Eosinophils in Blood Samples - Step 1 | 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 | 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. |
| Levels of Haemoglobin in Blood Samples - Step 1 | 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 | 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. |
| Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | 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 | 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. |
| Levels of Lymphocytes in Blood Samples - Step 1 | 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 | 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. |
| Levels of Monocytes in Blood Samples - Step 1 | 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 | 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. |
| Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | 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 | 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. |
| Levels of Neutrophils in Blood Samples - Step 1 | 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 | 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. |
| Platelet Count in Blood Samples - Step 1 | 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 | 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. |
| Levels of Urea in Blood Samples - Step 1 | 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 | 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. |
| Levels of White Blood Cells (WBC) - Step 1 | 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 | 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. |
| Levels of Diastolic Blood Pressure - Step 1 | 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 | 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). |
| Levels of Heart Rate - Step 1 | 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 | 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). |
| Levels of Respiratory Rate - Step 1 | 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 | 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). |
| Levels of Systolic Pressure - Step 1 | 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 | 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). |
| Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno | At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group) | 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). |
| Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence | At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group) | 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). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses | 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. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses | 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses | 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses | 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). |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2 | Within the 28-day (Days 0-27) and post-vaccination period | 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. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step | Within the 28-day (Days 0-27) post-vaccination period. | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) - Step 2 | Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step | Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group | 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. |
| Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2 | Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group | 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. |
| Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step | Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group | 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. |
| Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2 | Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group | 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. |
| Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step | Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group | 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. |
| Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | 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 | Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L). |
| Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | 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 | Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L). |
| Levels of Basophils in Blood Samples - Step 2 | 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 | Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L). |
| Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | 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 | Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L). |
| Levels of Eosinophils in Blood Samples - Step 2 | 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 | Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L). |
| Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | 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 | Haematological laboratory parameters assessed included white blood cells levels. WBC levels were expressed in billion cells per liter (billion cells/L). |
| Levels of Lymphocytes in Blood Samples - Step 2 | 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 | Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L). |
| Levels of Monocytes in Blood Samples - Step 2 | 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 | Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L). |
| Levels of Neutrophils in Blood Samples - Step 2 | 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 | Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L). |
| Platelet Count in Blood Samples - Step 2 | 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 | Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L). |
| Levels of Total Bilirubin in Blood Samples - Step 2 | 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 | Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL). |
| Levels of Diastolic Blood Pressure - Step 2 | 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 | 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). |
| Levels of Heart Rate - Step 2 | 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 | 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). |
| Levels of Respiratory Rate - Step 2 | 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 | 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). |
| Levels of Systolic Pressure - Step 2 | 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 | 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). |
| -Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination | 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). |
| Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination | 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). |
| Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination | 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). |
| Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Up to 3 days post-placebo/vaccine administration. | 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. |
| Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step | Up to 3 days post-Dose 2 vaccine administration in HBsAg/AS_1+2 Group | 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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; and 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. | 40 |
| 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 Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-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. | 41 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Investigator call for AEs check | 1 | 0 |
| Overall Study | Personal problem | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | HBsAg/AS_1+2 Group | Engerix-B_1+2 Group | Total |
|---|---|---|---|
| Age, Continuous | 39.2 Years STANDARD_DEVIATION 4.1 | 37.5 Years STANDARD_DEVIATION 5.9 | 38.4 Years STANDARD_DEVIATION 5.2 |
| Race/Ethnicity, Customized Geographic ancestry African Heritage / African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic / North African Heritage | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian / European Heritage | 38 Participants | 39 Participants | 77 Participants |
| Sex: Female, Male Female | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 40 |
| other Total, other adverse events | 16 / 38 | 13 / 40 |
| serious Total, serious adverse events | 0 / 38 | 1 / 40 |
Outcome results
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.
Time frame: Post-placebo at Day -30 plus 6 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-18 | 176 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | E-selectin | 5200 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-6r | 27000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-8 | 4.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IP-10 | 217 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MCP-1 | 104 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MCP-2 | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MCP-4 | 1310 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MIG | 500 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MIP-1 beta | 166 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MIP-3 alpha | 21 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MPIF-1 | 1500 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | E-selectin | 6050 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-8 | 4.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IP-10 | 218 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MPIF-1 | 1400 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-18 | 177.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MCP-1 | 101 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MIP-1 beta | 146 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MCP-2 | 20.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MCP-4 | 1245 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MIP-3 alpha | 20 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-6r | 24500 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | MIG | 378 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose1 at Day 0 plus 6 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-18 | 170 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | E-selectin | 5400 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-6 | 3.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-8 | 4.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IP-10 | 207 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-1 | 94 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-2 | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-4 | 1130 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MIG | 459 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-1 beta | 165 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-3 alpha | 19 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MPIF-1 | 1400 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | E-selectin | 5900 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-8 | 4.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IP-10 | 204 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-18 | 169 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-1 | 85 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-1 beta | 141 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-2 | 18.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-4 | 1130 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-3 alpha | 18.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-6r | 25000 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | MIG | 372.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 1 at Day 30
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | E-selectin | 6200 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-18 | 166.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-6r | 29000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IL-8 | 4.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | IP-10 | 231.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | MCP-1 | 46 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | MCP-2 | 19.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | MCP-4 | 1340 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | MIP-1 beta | 172 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | MIP-3 alpha | 25 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | MPIF-1 | 1200 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines During Step 2 | TNF-beta | 3 pg/mL |
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.
Time frame: Post-placebo at Day -30 plus 3 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-18 | 168 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | E-selectin | 5600 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-6r | 28000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-8 | 4.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IP-10 | 223 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MCP-1 | 79 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MCP-2 | 21 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MCP-4 | 1170 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MIG | 439 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MIP-1 beta | 163 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MIP-3 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MPIF-1 | 1600 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | E-selectin | 6300 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-8 | 4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IP-10 | 217.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-18 | 173 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MCP-1 | 64 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MIP-1 beta | 127 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MCP-4 | 1175 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MIP-3 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-6r | 26000 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | MIG | 343 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose1 at Day 0 plus 1.5 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-8 | 4.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IP-10 | 224 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-1 | 74 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-2 | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-4 | 1240 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MIG | 423 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-1 beta | 164 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-3 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MPIF-1 | 1500 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | TNF-beta | 3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-18 | 168 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | E-selectin | 5500 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | E-selectin | 5900 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-8 | 4.2 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IP-10 | 226 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-1 | 75 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-4 | 1240 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MIG | 378 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-18 | 168 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-1 beta | 137 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-3 alpha | 20 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | MPIF-1 | 1200 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-6r | 25000 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines in Step 1 of Study | TNF-alpha | 13 pg/mL |
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.
Time frame: Post-dose2 at Day 30 plus 6 Hours
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | E-selectin | 5400 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-18 | 172 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-6 | 3.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-6r | 34000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-7 | 12 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IL-8 | 6.1 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | IP-10 | 163 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | MCP-1 | 59 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | MCP-2 | 22 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | MCP-4 | 1330 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | MIP-1 beta | 182 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | MIP-3 alpha | 21 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | MPIF-1 | 1300 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines in Step 2 | TNF-beta | 3 pg/mL |
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.
Time frame: At Day -30 prior to placebo administration
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-18 | 198 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | E-selectin | 6000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-8 | 5.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IP-10 | 225 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MCP-1 | 107 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MCP-2 | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MCP-4 | 1230 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MIG | 513 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MIP-1 alpha | 20 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MIP-1 beta | 190 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MIP-3 alpha | 25 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MPIF-1 | 1600 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | E-selectin | 6250 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-8 | 5.1 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MIP-1 alpha | 20 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IP-10 | 247.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MPIF-1 | 1450 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-18 | 177 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MCP-1 | 98.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MIP-1 beta | 138 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MCP-2 | 19.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MCP-4 | 1170 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MIP-3 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-6r | 22500 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | MIG | 435 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Pre-dose 1 at Day 0
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | E-selectin | 8100 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-18 | 199.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-6r | 32000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-8 | 5.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IP-10 | 300.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MCP-1 | 86.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MCP-2 | 22.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MCP-4 | 1805 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MIP-1 beta | 234 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MIP-3 alpha | 28.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MPIF-1 | 1095 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | E-selectin | 5400 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-8 | 4.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MPIF-1 | 1100 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IP-10 | 234 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-18 | 179 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MIP-1 beta | 253 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MCP-1 | 87 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MCP-2 | 27 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MIP-3 alpha | 29 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | MCP-4 | 2120 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | IL-6r | 30000 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Step 2 | TNF-alpha | 13 pg/mL |
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.
Time frame: Pre-dose1 at Day 0
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | TNF-beta | 3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-3 alpha | 20 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | E-selectin | 6100 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MIG | 496 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-6r | 27000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MPIF-1 | 1500 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-8 | 4.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-1 beta | 164 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IP-10 | 243 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-1 | 94 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-2 | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-18 | 169 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-4 | 1310 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MIG | 462.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-1 beta | 153 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-3 alpha | 19.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | E-selectin | 6150 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-18 | 171 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-4 | 1260 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-6r | 24500 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IL-8 | 5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | IP-10 | 225 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-1 | 92.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-2 | 19 pg/mL |
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.
Time frame: Post-placebo at Day -30 plus 18 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-18 | 174 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-2 | 6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | E-selectin | 4950 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-6r | 21500 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-8 | 5.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IP-10 | 243.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MCP-1 | 98 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MCP-2 | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MCP-4 | 1445 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MIG | 420 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MIP-1 beta | 143.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MIP-3 alpha | 30 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MPIF-1 | 1400 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | E-selectin | 4200 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-8 | 6.1 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IP-10 | 238 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MPIF-1 | 1100 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-18 | 142 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MCP-1 | 109 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MIP-1 beta | 165 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MCP-2 | 17 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MCP-4 | 1390 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MIP-3 alpha | 20 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-6r | 21000 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | MIG | 458 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines During Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 2 at Day 180
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | E-selectin | 4900 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-18 | 159 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-6r | 24000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IL-8 | 4.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | IP-10 | 156 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | MCP-1 | 77 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | MCP-2 | 20 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | MCP-4 | 1640 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | MIP-1 beta | 189 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | MIP-3 alpha | 25 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | MPIF-1 | 920 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines During Step 2 | TNF-beta | 3 pg/mL |
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.
Time frame: Post-placebo at Day -30 plus 12 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-18 | 171 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | E-selectin | 5200 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-8 | 4.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IP-10 | 217 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MCP-1 | 117 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MCP-2 | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MCP-4 | 1260 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MIG | 460 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MIP-1 beta | 159 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MIP-3 alpha | 21 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MPIF-1 | 1400 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | E-selectin | 5600 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-8 | 4.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IP-10 | 214 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-18 | 180 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MCP-1 | 120 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MIP-1 beta | 137 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MCP-2 | 19 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MCP-4 | 1160 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MIP-3 alpha | 22 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-6r | 24000 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | MIG | 412 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines in Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 2 at Day 37
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | E-selectin | 6550 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-18 | 232 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-4 | 9.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-6r | 28000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IL-8 | 8.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | IP-10 | 170 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | MCP-1 | 72.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | MCP-2 | 18.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | MCP-4 | 1275 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | MIP-1 beta | 174 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | MIP-3 alpha | 17 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | MPIF-1 | 1100 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines in Step 2 | TNF-beta | 3 pg/mL |
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.
Time frame: Post-placebo at Day -30 plus 9 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MCP-1 | 86 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MCP-2 | 17 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | E-selectin | 5300 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IP-10 | 210 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-18 | 173 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-6r | 24000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-8 | 4.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MCP-4 | 1310 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MIG | 452 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MIP-1 beta | 131 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MIP-3 alpha | 19 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MPIF-1 | 1400 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IP-10 | 205.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MCP-1 | 81 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MCP-2 | 17 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-6r | 26000 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | E-selectin | 6100 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MPIF-1 | 1200 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MIP-1 beta | 119.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-8 | 4.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-18 | 167.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MCP-4 | 1145 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MIP-3 alpha | 15 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | MIG | 327 pg/mL |
| Engerix-B_1 Group | Concentrations of Cytokines/Chemokines - Step 1 | IL-5 | 2.7 pg/mL |
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.
Time frame: Post-dose 2 at Day 31
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | E-selectin | 7450 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IFN-γ | 6.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-18 | 234 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-4 | 9.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-6 | 4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-6r | 30500 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-7 | 10.1 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IL-8 | 7.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | IP-10 | 737.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | MCP-1 | 142.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | MCP-2 | 40.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | MCP-4 | 1330 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | MIP-1 beta | 580 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | MIP-3 alpha | 28 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | MPIF-1 | 1750 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Cytokines/Chemokines - Step 2 | TNF-beta | 3 pg/mL |
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.
Time frame: Post-dose 2 at Day 37
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-18 | 194 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | E-selectin | 6200 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-6r | 28000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-8 | 5.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IP-10 | 259 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MCP-1 | 83 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MCP-2 | 17 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MCP-4 | 1220 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MIG | 447 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MIP-1 beta | 150 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MIP-3 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MPIF-1 | 1600 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | E-selectin | 6000 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-8 | 5.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IP-10 | 223 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-18 | 166 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MCP-1 | 85 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MIP-1 beta | 151 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MCP-4 | 1210 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MIP-3 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-6r | 25000 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | MIG | 364 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines During Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 2 at Day 33
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-18 | 256 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | E-selectin | 6400 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-8 | 5.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IP-10 | 366 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MCP-1 | 85 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MCP-2 | 20 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MCP-4 | 1390 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MIG | 796 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MIP-1 alpha | 22 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MIP-1 beta | 241 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MIP-3 alpha | 25 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MPIF-1 | 1800 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | E-selectin | 6300 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-8 | 5.5 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MIP-1 alpha | 19 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IP-10 | 249 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-18 | 181 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MCP-1 | 93 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MIP-1 beta | 163 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MCP-4 | 1280 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MIP-3 alpha | 25 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-6r | 25000 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | MIG | 537 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines in Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 2 at Day 32
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-10 | 3.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-18 | 238 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | E-selectin | 7000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-6r | 27000 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-8 | 5.5 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IP-10 | 760 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MCP-1 | 75 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MCP-2 | 24 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MCP-4 | 1350 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MIG | 850 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MIP-1 beta | 268 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MIP-3 alpha | 23 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MPIF-1 | 1800 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | E-selectin | 6000 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-8 | 5.1 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IP-10 | 226 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MPIF-1 | 1200 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-18 | 190 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MCP-1 | 77 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MIP-1 beta | 142 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MCP-2 | 21 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MCP-4 | 1260 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MIP-3 alpha | 19 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-6r | 24000 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | MIG | 410 pg/mL |
| Engerix-B_1 Group | Concentrations of Plasma Cytokines and Chemokines - Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-placebo at Day -23
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-18 | 184 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | E-selectin | 5500 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-6r | 27000 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-8 | 4.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IP-10 | 241 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MCP-1 | 88 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MCP-2 | 15 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MCP-4 | 1390 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MIG | 391 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MIP-1 beta | 165 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MIP-3 alpha | 21 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MPIF-1 | 1600 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | E-selectin | 6150 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-8 | 5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IP-10 | 223 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MPIF-1 | 1350 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-18 | 176.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MCP-1 | 72 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MIP-1 beta | 138.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MCP-2 | 19 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MCP-4 | 1145 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MIP-3 alpha | 16 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-6r | 23500 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | MIG | 375.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose1 at Day 1
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-10 | 5.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-18 | 198.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | E-selectin | 5950 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-6 | 3 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-6r | 26500 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-8 | 5.1 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IP-10 | 295 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MCP-1 | 85.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MCP-2 | 21 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MCP-4 | 1360 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MIG | 526 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MIP-1 beta | 282.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MIP-3 alpha | 17 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MPIF-1 | 2300 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | E-selectin | 6000 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-8 | 4.4 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IP-10 | 219 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MPIF-1 | 1400 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-18 | 181 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MCP-1 | 92 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MIP-1 beta | 145 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MCP-4 | 1270 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MIP-3 alpha | 16 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-6r | 24500 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | MIG | 425 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations During Step 1 of Study | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-placebo at Day -29
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-18 | 186 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | E-selectin | 5900 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-6r | 27000 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-8 | 5.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IP-10 | 241 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MCP-1 | 93 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MCP-2 | 19 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MCP-4 | 1230 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MIG | 528 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MIP-1 alpha | 19 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MIP-1 beta | 169 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MIP-3 alpha | 22 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MPIF-1 | 1700 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | E-selectin | 6350 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-8 | 5.2 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IP-10 | 244.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MPIF-1 | 1500 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-18 | 177.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MCP-1 | 81.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MIP-1 beta | 141.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MCP-2 | 19 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MCP-4 | 1170 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MIP-3 alpha | 21 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-6r | 26500 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | MIG | 418.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose1 at Day 0 plus 18 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IFN-γ | 1.8 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-18 | 180 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | E-selectin | 5750 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-6 | 4.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-6r | 22500 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-8 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IP-10 | 319 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MCP-1 | 111 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MCP-2 | 29.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MCP-4 | 1400 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MIG | 571 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MIP-1 beta | 258 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MIP-3 alpha | 35.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MPIF-1 | 1850 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | E-selectin | 4700 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-8 | 5.1 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IP-10 | 228 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MPIF-1 | 1400 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-18 | 126 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MCP-1 | 115 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MIP-1 beta | 134 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MCP-4 | 1400 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MIP-3 alpha | 20 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-6r | 22000 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | MIG | 473 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations in Step 1 of Study | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-placebo at Day -30 plus 1.5 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-18 | 172 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | E-selectin | 5900 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-8 | 4.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IP-10 | 220 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MCP-1 | 79 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MCP-2 | 17 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MCP-4 | 1300 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MIG | 392 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MIP-1 beta | 141 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MIP-3 alpha | 16 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MPIF-1 | 1500 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | E-selectin | 6450 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-8 | 4.2 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IP-10 | 207 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MPIF-1 | 1400 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-18 | 179.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MCP-1 | 77.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MIP-1 beta | 124.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MCP-2 | 19 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MCP-4 | 1190 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MIP-3 alpha | 16 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-6r | 22000 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | MIG | 336 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 1 at Day 1
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | E-selectin | 7900 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-10 | 3.8 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-18 | 206 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-6 | 1.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-6r | 24000 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IL-8 | 3.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | IP-10 | 294 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | MCP-1 | 35 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | MCP-2 | 26 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | MCP-4 | 1240 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | MIP-1 beta | 318 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | MIP-3 alpha | 32 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | MPIF-1 | 1400 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Step 2 | TNF-beta | 3 pg/mL |
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.
Time frame: Post-dose1 at Day 0 plus 12 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-10 | 3.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-18 | 171 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | E-selectin | 5900 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-6 | 6.3 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-8 | 4.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IP-10 | 236 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MCP-1 | 111 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MCP-2 | 19 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MCP-4 | 1260 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MIG | 478 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MIP-1 beta | 183 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MIP-3 alpha | 20 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MPIF-1 | 1600 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | E-selectin | 6400 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-8 | 4.8 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IP-10 | 194 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-18 | 181.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MCP-1 | 111.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MIP-1 beta | 132 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MCP-2 | 19.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MCP-4 | 1265 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MIP-3 alpha | 19.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-6r | 24000 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | MIG | 410 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concentrations - Study Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-placebo at Day -28
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MIG | 468 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MIP-1 beta | 174 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-8 | 4.8 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MIP-3 alpha | 20 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MPIF-1 | 1500 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IP-10 | 270 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | TNF-beta | 3 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MCP-1 | 74 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | E-selectin | 5900 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MCP-2 | 19 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-6r | 27000 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MCP-4 | 1200 pg/mL |
| HBsAg/AS_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-18 | 182 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MIP-1 beta | 151.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-6r | 25500 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-8 | 4.9 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IP-10 | 228 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MCP-1 | 73.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MCP-2 | 18.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MCP-4 | 1140 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MIG | 397 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-18 | 178.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MIP-3 alpha | 17.5 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | MPIF-1 | 1350 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | E-selectin | 6250 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines and Chemokines Concetrations During Step 1 | IL-10 | 3.3 pg/mL |
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.
Time frame: Post-dose1 at Day 30
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-18 | 202 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | E-selectin | 6200 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-6r | 27000 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-8 | 4.8 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IP-10 | 245 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MCP-1 | 99 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MCP-2 | 16 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MCP-4 | 1180 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MIG | 475 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MIP-1 beta | 175 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MIP-3 alpha | 20 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MPIF-1 | 1500 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | E-selectin | 6500 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-8 | 4.3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IP-10 | 235 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-18 | 183 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MCP-1 | 86 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MIP-1 beta | 147 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MCP-4 | 1010 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MIP-3 alpha | 20 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-6r | 26000 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | MIG | 452 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations During Step 1 of Study | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-placebo at Day -27
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-10 | 3.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-18 | 183 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | E-selectin | 6150 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-8 | 4.3 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IP-10 | 239 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MCP-1 | 84.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MCP-2 | 18.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MCP-4 | 1150 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MIG | 429.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MIP-1 beta | 165 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MIP-3 alpha | 20.5 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MPIF-1 | 1350 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | E-selectin | 6250 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-8 | 4.2 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IP-10 | 220.5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-18 | 174.5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MCP-1 | 86.5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MIP-1 beta | 141 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MCP-4 | 1060 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MIP-3 alpha | 21 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-6r | 24000 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | MIG | 403.5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose1 at Day 7
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-8 | 5 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IP-10 | 235 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-10 | 3.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MCP-1 | 94 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | E-selectin | 6600 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MCP-4 | 1250 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MIG | 475 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-18 | 202 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MIP-1 beta | 171 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MIP-3 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-6r | 27000 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MPIF-1 | 1600 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | TNF-beta | 3 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | E-selectin | 6700 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-18 | 191 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-6r | 25000 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IL-8 | 5.1 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | IP-10 | 220.5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MCP-1 | 88.5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MCP-2 | 22.5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MCP-4 | 1240 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MIG | 436.5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MIP-1 beta | 173.5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MIP-3 alpha | 22 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations in Step 1 of Study | TNF-alpha | 13 pg/mL |
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.
Time frame: Post-dose1 at Day 2
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-10 | 3.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-18 | 219 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | E-selectin | 5800 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-6r | 25000 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-8 | 4.8 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IP-10 | 455 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MCP-1 | 83 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MCP-2 | 22 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MCP-4 | 1300 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MIG | 546 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MIP-1 beta | 200 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MIP-3 alpha | 19 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MPIF-1 | 1600 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | E-selectin | 6300 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-8 | 5 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IP-10 | 214 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-18 | 167 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MCP-1 | 79 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MIP-1 beta | 149 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MCP-2 | 20 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MCP-4 | 1230 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MIP-3 alpha | 21 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-6r | 24000 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | MIG | 364 pg/mL |
| Engerix-B_1 Group | Cytokines/Chemokines Concentrations - Study Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 2 at Day 30 plus 9 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | E-selectin | 6200 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-8 | 4.1 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IP-10 | 217 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-1 | 103 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MPIF-1 | 1400 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-4 | 1190 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MIG | 424 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-1 beta | 167 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-6 | 4.8 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-3 alpha | 16 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-18 | 177 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-6r | 23000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | TNF-beta | 3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-2 | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-3 alpha | 15.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | E-selectin | 5500 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-18 | 165 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-6r | 24500 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IL-8 | 4 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | IP-10 | 204 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-1 | 80 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-2 | 18.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MCP-4 | 1075 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MIG | 350 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MIP-1 beta | 123.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | MPIF-1 | 1200 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study | TNF-alpha | 13 pg/mL |
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.
Time frame: Post-dose 3 at Day 187
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | E-selectin | 4600 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-18 | 163 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-6r | 30000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IL-8 | 3.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | IP-10 | 201 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | MCP-1 | 35 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | MCP-2 | 22 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | MCP-4 | 1810 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | MIP-1 beta | 175 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | MIP-3 alpha | 17 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | MPIF-1 | 820 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study | TNF-beta | 3 pg/mL |
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.
Time frame: Post-dose 2 at Day 30 plus 6 hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-1 beta | 177.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-3 alpha | 16 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MPIF-1 | 1400 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | TNF-beta | 3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | E-selectin | 6000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-6 | 4.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-6r | 23000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-8 | 5.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IP-10 | 210.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-1 | 116.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-2 | 17 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-4 | 1245 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MIG | 375 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-18 | 173.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-18 | 183 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-1 beta | 139.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-3 alpha | 16 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-2 | 18.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-6r | 24500 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-4 | 1065 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | E-selectin | 5850 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-8 | 4.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IP-10 | 196.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MIG | 387.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | MCP-1 | 95 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study | IL-5 | 2.7 pg/mL |
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.
Time frame: Post-dose 3 at Day 181
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | E-selectin | 4900 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-18 | 152 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-6r | 24500 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IL-8 | 3.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | IP-10 | 152 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | MCP-1 | 67 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | MCP-2 | 19.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | MCP-4 | 1720 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | MIP-1 beta | 173.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | MIP-3 alpha | 17 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | MPIF-1 | 875 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study | TNF-beta | 3 pg/mL |
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.
Time frame: Post-dose 2 at Day 30 plus 1.5 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-18 | 171 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | E-selectin | 6300 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-6r | 24000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-8 | 3.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IP-10 | 223 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MCP-1 | 85 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MCP-2 | 15 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MCP-4 | 1250 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MIG | 421 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MIP-1 beta | 164 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MIP-3 alpha | 17 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MPIF-1 | 1400 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | E-selectin | 5700 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-8 | 4.3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IP-10 | 215 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MPIF-1 | 1200 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-18 | 176 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MCP-1 | 87 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MIP-1 beta | 136 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MCP-2 | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MCP-4 | 1090 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MIP-3 alpha | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-6r | 25000 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | MIG | 367 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 2 at Day 30 plus 3 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-18 | 171.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | E-selectin | 6550 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-8 | 4.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IP-10 | 208 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-1 | 75 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-2 | 15.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-4 | 1095 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MIG | 378.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-1 beta | 153 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-3 alpha | 15 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MPIF-1 | 1500 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | E-selectin | 5700 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-8 | 4.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IP-10 | 205.5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MPIF-1 | 1200 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-18 | 158 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-1 | 75 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-1 beta | 138 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-2 | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MCP-4 | 1085 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MIP-3 alpha | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-6r | 23000 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | MIG | 358 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 1 | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 3 at Day 180 plus 6 Hours
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | E-selectin | 4600 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IFN-γ | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-18 | 144 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-6 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-6r | 25000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IL-8 | 3.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | IP-10 | 145 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | MCP-1 | 46 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | MCP-2 | 22 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | MCP-4 | 1640 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | MIP-1 beta | 193 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | MIP-3 alpha | 21 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | MPIF-1 | 890 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines and Chemokines - Study Step 2 | TNF-beta | 3 pg/mL |
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.
Time frame: Post-dose 2 at Day 30 plus 12 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-8 | 4.9 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IP-10 | 240 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-10 | 3.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MCP-1 | 117 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | E-selectin | 5800 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MCP-2 | 20 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MCP-4 | 1100 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MIG | 499 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-18 | 166 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-6 | 6.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MIP-1 beta | 191 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IFN-γ | 2.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MIP-3 alpha | 20 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-6r | 23000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MPIF-1 | 1500 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | TNF-beta | 3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | E-selectin | 5800 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-18 | 174 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-6r | 24000 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-7 | 8.2 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IL-8 | 5.2 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | IP-10 | 200 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MCP-1 | 95 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MCP-2 | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MCP-4 | 1040 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MIG | 377 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MIP-1 beta | 134 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MIP-3 alpha | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | MPIF-1 | 1300 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study | TNF-alpha | 13 pg/mL |
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.
Time frame: Post-dose 2 at Day 31
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IFN-γ | 4.8 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-10 | 4.8 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-18 | 185 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-2 | 8.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | E-selectin | 6800 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-6 | 3.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-6r | 26000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-8 | 5.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IP-10 | 763 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MCP-1 | 101 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MCP-2 | 35 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MCP-4 | 1250 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MIG | 763 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MIP-1 beta | 383 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MIP-3 alpha | 22 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MPIF-1 | 2000 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | TNF-alpha | 15 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | E-selectin | 5800 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-8 | 4.8 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IP-10 | 212 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MPIF-1 | 1100 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-18 | 166 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MCP-1 | 71 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MIP-1 beta | 142 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MCP-2 | 17 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MCP-4 | 1090 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MIP-3 alpha | 19 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-6r | 24000 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | MIG | 427 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study | IL-7 | 8.2 pg/mL |
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.
Time frame: Post-dose 2 at Day 30 plus 18 Hours
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-3 | 1.6 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | GM-CSF | 14 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IFN-γ | 5.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-10 | 4.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-18 | 164.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-2 | 5.9 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | E-selectin | 5400 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-4 | 9.4 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-5 | 2.7 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-6 | 6.3 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-6r | 19500 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-7 | 8.2 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-8 | 4.8 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IP-10 | 589.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MCP-1 | 104.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MCP-2 | 33 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MCP-4 | 1220 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MIG | 565.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MIP-1 beta | 283.5 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MIP-3 alpha | 24 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MPIF-1 | 1600 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | TNF-alpha | 13 pg/mL |
| HBsAg/AS_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | TNF-alpha | 13 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | E-selectin | 4500 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-8 | 5 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | GM-CSF | 14 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MIP-1 alpha | 18 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IFN-γ | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IP-10 | 216 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-10 | 3.3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MPIF-1 | 1400 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-18 | 168 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MCP-1 | 96 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-2 | 5.9 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MIP-1 beta | 144 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-3 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MCP-2 | 22 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-4 | 9.4 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | TNF-beta | 3 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-5 | 2.7 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MCP-4 | 1260 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-6 | 1.6 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MIP-3 alpha | 17 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-6r | 24000 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | MIG | 442 pg/mL |
| Engerix-B_1 Group | Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study | IL-7 | 8.2 pg/mL |
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).
Time frame: At Day 0 (PRE) and Day 60 (D60) post-vaccination
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1 | Anti-HBs, PRE (D0) | 3.1 mIU/mL |
| HBsAg/AS_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1 | Anti-HBs, PII (D60) | 3322.4 mIU/mL |
| Engerix-B_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1 | Anti-HBs, PRE (D0) | 3.1 mIU/mL |
| Engerix-B_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1 | Anti-HBs, PII (D60) | 35.8 mIU/mL |
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).
Time frame: At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno | Anti-HBs, PRE | 3.1 mIU/mL |
| HBsAg/AS_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno | Anti-HBs, D44 | 8447.1 mIU/mL |
| Engerix-B_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno | Anti-HBs, PRE | 3.1 mIU/mL |
| Engerix-B_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno | Anti-HBs, D194 | 1996.3 mIU/mL |
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).
Time frame: At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence | Anti-HBs, PRE | 3.1 mIU/mL |
| HBsAg/AS_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence | Anti-HBs, D44 | 8447.1 mIU/mL |
| Engerix-B_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence | Anti-HBs, PRE | 3.1 mIU/mL |
| Engerix-B_1 Group | Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence | Anti-HBs, D194 | 2454.9 mIU/mL |
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).
Time frame: At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | -Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | PRE | 8 T cells/million cells |
| HBsAg/AS_1 Group | -Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 44 | 4494 T cells/million cells |
| Engerix-B_1 Group | -Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | PRE | 1 T cells/million cells |
| Engerix-B_1 Group | -Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 44 | 268 T cells/million cells |
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).
Time frame: At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | PRE | 8 T cells/ million cells |
| HBsAg/AS_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 44 | 4494 T cells/ million cells |
| HBsAg/AS_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 180 | 1119 T cells/ million cells |
| Engerix-B_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | PRE | 1 T cells/ million cells |
| Engerix-B_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 44 | 260 T cells/ million cells |
| Engerix-B_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 180 | 34 T cells/ million cells |
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).
Time frame: At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | PRE | 1 T cells/ million cells |
| HBsAg/AS_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 44 | 38 T cells/ million cells |
| Engerix-B_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | PRE | 1 T cells/ million cells |
| Engerix-B_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 44 | 1 T cells/ million cells |
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).
Time frame: At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | PRE | 1 T ceclls/ million cells |
| HBsAg/AS_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 44 | 38 T ceclls/ million cells |
| HBsAg/AS_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 180 | 1 T ceclls/ million cells |
| Engerix-B_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | PRE | 1 T ceclls/ million cells |
| Engerix-B_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 44 | 1 T ceclls/ million cells |
| Engerix-B_1 Group | Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 | Day 180 | 1 T ceclls/ million cells |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1 (Day 0 H12) | 27 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2 (Day 30 H6) | 27 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1, Day 1 | 25.5 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2 (Day 30 H12) | 27 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1 (Day 0 H6) | 26.5 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2 (Day 30 H18) | 32 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1, Day 7 | 26.5 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2, Day 31 | 27 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1 (Day 0 H18) | 28 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2, Day 37 | 27 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2, Day 30 | 27 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2, Day 60 | 28 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1, Day 0 | 27.5 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2, Day 60 | 28 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1, Day 0 | 27 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1 (Day 0 H6) | 26 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1 (Day 0 H12) | 26 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1 (Day 0 H18) | 24 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1, Day 1 | 27 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 1, Day 7 | 28 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2, Day 30 | 30 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2 (Day 30 H6) | 28 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2 (Day 30 H12) | 28 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2 (Day 30 H18) | 26 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2, Day 31 | 27 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 | ALT, Dose 2, Day 37 | 26 U/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, PRE | 27.5 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, D30 | 25.5 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, D32 | 27 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, D37 | 23 U/L |
| HBsAg/AS_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, D60 | 30 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, D210 | 29.5 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, PRE | 31 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, D180 | 34.5 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, D182 | 31 U/L |
| Engerix-B_1 Group | Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 | ALT, D187 | 34 U/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1 (Day 0 H12) | 20 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2 (Day 30 H6) | 21 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1, Day 1 | 19 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2 (Day 30 H12) | 20 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1 (Day 0 H6) | 20.5 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2 (Day 30 H18) | 20 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1, Day 7 | 21 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2, Day 31 | 19 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1 (Day 0 H18) | 19 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2, Day 37 | 22 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2, Day 30 | 21 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2, Day 60 | 21 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1, Day 0 | 21 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2, Day 60 | 21.5 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1, Day 0 | 23 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1 (Day 0 H6) | 21 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1 (Day 0 H12) | 20 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1 (Day 0 H18) | 18 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1, Day 1 | 20 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 1, Day 7 | 21 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2, Day 30 | 23 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2 (Day 30 H6) | 22 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2 (Day 30 H12) | 21 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2 (Day 30 H18) | 19.5 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2, Day 31 | 21 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 | AST, Dose 2, Day 37 | 23 U/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, PRE | 22.5 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, D30 | 22.5 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, D32 | 24 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, D37 | 20.5 U/L |
| HBsAg/AS_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, D60 | 21.5 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, D210 | 22.5 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, PRE | 28 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, D180 | 25 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, D182 | 29 U/L |
| Engerix-B_1 Group | Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 | AST, D187 | 25 U/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1 (Day 0 H12) | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2 (Day 30 H6) | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1, Day 1 | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2 (Day 30 H12) | 0.02 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1 (Day 0 H6) | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2 (Day 30 H18) | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1, Day 7 | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2, Day 31 | 0.02 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1 (Day 0 H18) | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2, Day 37 | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2, Day 30 | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2, Day 60 | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1, Day 0 | 0.03 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2, Day 60 | 0.03 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1, Day 0 | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1 (Day 0 H6) | 0.03 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1 (Day 0 H12) | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1 (Day 0 H18) | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1, Day 1 | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 1, Day 7 | 0.03 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2, Day 30 | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2 (Day 30 H6) | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2 (Day 30 H12) | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2 (Day 30 H18) | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2, Day 31 | 0.03 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 1 | Basophils, Dose 2, Day 37 | 0.03 billion cells/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, PRE | 0.04 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, D30 | 0.02 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, D32 | 0.04 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, D37 | 0.03 billion cells/L |
| HBsAg/AS_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, D60 | 0.05 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, D210 | 0.03 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, PRE | 0.03 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, D180 | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, D182 | 0.02 billion cells/L |
| Engerix-B_1 Group | Levels of Basophils in Blood Samples - Step 2 | Basophils, D187 | 0.03 billion cells/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1 (Day 0 H12) | 1.5 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2 (Day 30 H6) | 1.2 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1, Day 1 | 5.8 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2 (Day 30 H12) | 1.8 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1 (Day 0 H6) | 0.8 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2 (Day 30 H18) | 3.15 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1, Day 7 | 1.9 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2, Day 31 | 5.8 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1 (Day 0 H18) | 2.9 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2, Day 37 | 2.1 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2, Day 30 | 1.3 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2, Day 60 | 1.4 mg/L |
| HBsAg/AS_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1, Day 0 | 1.15 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2, Day 60 | 1.05 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1, Day 0 | 1.7 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1 (Day 0 H6) | 1.6 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1 (Day 0 H12) | 1.4 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1 (Day 0 H18) | 1.25 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1, Day 1 | 1.2 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 1, Day 7 | 1.3 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2, Day 30 | 1.4 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2 (Day 30 H6) | 1.5 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2 (Day 30 H12) | 1.55 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2 (Day 30 H18) | 0.75 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2, Day 31 | 1.2 mg/L |
| Engerix-B_1 Group | Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 | CRP, Dose 2, Day 37 | 1.3 mg/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1 (Day 0 H12) | 64.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2 (Day 30 H6) | 81 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1, Day 1 | 54 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2 (Day 30 H12) | 72 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1 (Day 0 H6 | 69.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2 (Day 30 H18) | 68.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1, Day 7 | 66 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2, Day 31 | 67 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1 (Day 0 H18) | 59 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2, Day 37 | 83 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2, Day 30 | 83 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2, Day 60 | 82 mg/dL |
| HBsAg/AS_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1, Day 0 | 75 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2, Day 60 | 82.5 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1, Day 0 | 80 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1 (Day 0 H6 | 75 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1 (Day 0 H12) | 77 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1 (Day 0 H18) | 61 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1, Day 1 | 69 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 1, Day 7 | 80 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2, Day 30 | 87 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2 (Day 30 H6) | 86 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2 (Day 30 H12) | 80.5 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2 (Day 30 H18) | 70 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2, Day 31 | 75 mg/dL |
| Engerix-B_1 Group | Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 | CPK, Dose 2, Day 37 | 93.5 mg/dL |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0 H12) | 72 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0 H18) | 73 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D60) | 78 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30) | 81 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H1.5) | 75 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H3) | 75.5 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H6) | 73.5 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H9) | 76 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H12) | 78 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H18) | 75 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-29) | 77 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-28) | 75 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-27) | 78 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-23) | 76 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0) | 76 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0 H1.5) | 74 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0 H6) | 73.5 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D1) | 72 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D2) | 74 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D7) | 75 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30) | 76 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H1.5) | 72 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H3) | 72 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H6) | 72 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H9) | 75 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H12) | 73 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H18) | 70 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D31) | 71 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D32) | 77 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D33) | 77 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D37) | 76 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0 H1.5) | 73 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0 H12) | 72 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H18) | 71.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D37) | 74 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0 H6) | 72 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D60) | 73 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0 H18) | 66.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30) | 76.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H6) | 70.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H1.5) | 72 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D1) | 76 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H3) | 71.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D32) | 74 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H6) | 71.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D2) | 73 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H9) | 75 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H9) | 75 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H12) | 72.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D7) | 73 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-30 H18) | 68 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D31) | 71 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-29) | 73.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30) | 77.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-28) | 74.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H12) | 72.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-27) | 75 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H1.5) | 70 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, placebo (D-23) | 75.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D33) | 73 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 1 (D0) | 76 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 1 | Diastolic, Dose 2 (D30 H3) | 72 mmHg |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D0 | 74 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D30 H0 | 74.5 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D30 H6 | 71 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D31 | 71.5 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D32 | 71.5 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D37 | 70 mmHg |
| HBsAg/AS_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D60 | 72 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D210 | 71.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D0 | 70 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D180 H0 | 69 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D180 H6 | 68.5 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D181 | 72 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D182 | 70 mmHg |
| Engerix-B_1 Group | Levels of Diastolic Blood Pressure - Step 2 | Diastolic, D187 | 72 mmHg |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2, Day 30 | 0.18 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2 (Day 30 H6) | 0.18 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2 (Day 30 H12) | 0.19 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2 (Day 30 H18) | 0.14 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2, Day 31 | 0.14 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2, Day 37 | 0.19 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2, Day 60 | 0.19 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1, Day 0 | 0.2 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1 (Day 0 H6) | 0.19 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1 (Day 0 H12) | 0.21 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1 (Day 0 H18) | 0.16 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1, Day 1 | 0.15 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1, Day 7 | 0.14 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1 (Day 0 H18) | 0.2 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1, Day 0 | 0.13 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2 (Day 30 H6) | 0.13 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1, Day 7 | 0.11 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2 (Day 30 H12) | 0.14 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1 (Day 0 H6) | 0.13 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2 (Day 30 H18) | 0.19 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1, Day 1 | 0.1 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2, Day 31 | 0.13 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 1 (Day 0 H12) | 0.17 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2, Day 37 | 0.15 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2, Day 30 | 0.14 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 1 | Eosinophils, Dose 2, Day 60 | 0.14 billion cells/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, PRE | 0.16 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, D30 | 0.17 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, D32 | 0.25 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, D37 | 0.19 billion cells/L |
| HBsAg/AS_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, D60 | 0.2 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, D210 | 0.16 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, PRE | 0.18 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, D180 | 0.14 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, D182 | 0.17 billion cells/L |
| Engerix-B_1 Group | Levels of Eosinophils in Blood Samples - Step 2 | Eosinophils, D187 | 0.18 billion cells/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1 (Day 0 H12) | 13.25 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2 (Day 30 H6) | 13.4 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1, Day 1 | 13.5 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2 (Day 30 H12) | 13.2 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1 (Day 0 H6) | 13.45 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2 (Day 30 H18) | 13.15 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1, Day 7 | 13.35 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2, Day 31 | 13.5 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1 (Day 0 H18) | 12.6 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2, Day 37 | 13.6 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2, Day 30 | 13.7 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2, Day 60 | 13.5 g/dL |
| HBsAg/AS_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1, Day 0 | 13.35 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2, Day 60 | 13.8 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1, Day 0 | 13.8 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1 (Day 0 H6) | 13.6 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1 (Day 0 H12) | 13.2 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1 (Day 0 H18) | 13.15 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1, Day 1 | 13.8 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 1, Day 7 | 13.8 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2, Day 30 | 13.4 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2 (Day 30 H6) | 13.55 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2 (Day 30 H12) | 13.1 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2 (Day 30 H18) | 13.05 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2, Day 31 | 13.75 g/dL |
| Engerix-B_1 Group | Levels of Haemoglobin in Blood Samples - Step 1 | Haemoglobin, Dose 2, Day 37 | 13.65 g/dL |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H1.5) | 75 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30) | 75.5 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H3) | 69.5 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H6) | 69 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H9) | 66.5 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H12) | 71.5 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H18) | 66 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-29) | 74.5 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-28) | 70 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-27) | 72 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-23) | 72 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0) | 69.5 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0 H1.5) | 67.5 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0 H6) | 66 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0 H12) | 76 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0 H18) | 76 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D1) | 72 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D2) | 71.5 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D7) | 74 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30) | 65 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H1.5) | 69 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H3) | 66 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H6) | 73 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H9) | 72 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H12) | 79 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H18) | 84.5 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D31) | 81 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D32) | 70 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D33) | 69 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D37) | 67 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D60) | 72 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0 H18) | 67 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H9) | 65.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30) | 70 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H1.5) | 73 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D1) | 67 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H3) | 63.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D32) | 70.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H6) | 69 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D2) | 69 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H9) | 65 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H12) | 69.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H12) | 72.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D7) | 71 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-30 H18) | 70 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D37) | 72.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-29) | 65.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30) | 66.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-28) | 73.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H18) | 74.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-27) | 70 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H1.5) | 68.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, placebo (D-23) | 66 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D33) | 70.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0) | 72 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H3) | 65 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0 H1.5) | 68 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D31) | 66.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0 H6) | 68 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D30 H6) | 71.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 1 (D0 H12) | 69 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 1 | Heart rate, Dose 2 (D60) | 71 beats/minute |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 2 | Heart rate, PRE | 72 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D30 H0 | 70 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D30 H6 | 68 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D31 | 84 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D32 | 73 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D37 | 65 beats/minute |
| HBsAg/AS_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D60 | 65 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D210 | 76.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 2 | Heart rate, PRE | 70 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D180 H0 | 71.5 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D180 H6 | 70 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D181 | 81 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D182 | 72 beats/minute |
| Engerix-B_1 Group | Levels of Heart Rate - Step 2 | Heart rate, D187 | 78 beats/minute |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1 (Day 0 H12) | 412 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2 (Day 30 H6) | 437 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1, Day 1 | 389 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2 (Day 30 H12) | 425 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1 (Day 0 H6) | 414 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2 (Day 30 H18) | 403 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1, Day 7 | 417.5 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2, Day 31 | 408 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1 (Day 0 H18) | 422 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2, Day 37 | 442 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2, Day 30 | 391 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2, Day 60 | 422 U/L |
| HBsAg/AS_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1, Day 0 | 401.5 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2, Day 60 | 404 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1, Day 0 | 382 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1 (Day 0 H6) | 389 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1 (Day 0 H12) | 378 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1 (Day 0 H18) | 369.5 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1, Day 1 | 367 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 1, Day 7 | 392 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2, Day 30 | 395 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2 (Day 30 H6) | 396.5 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2 (Day 30 H12) | 382.5 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2 (Day 30 H18) | 334.5 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2, Day 31 | 372 U/L |
| Engerix-B_1 Group | Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 | LDH, Dose 2, Day 37 | 403 U/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1 (Day 0 H12) | 1.97 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2 (Day 30 H6) | 1.81 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1, Day 1 | 1.58 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2 (Day 30 H12) | 1.9 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1 (Day 0 H6) | 1.89 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2 (Day 30 H18) | 1.46 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1, Day 7 | 1.69 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2, Day 31 | 1.19 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1 (Day 0 H18) | 1.73 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2, Day 37 | 1.74 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2, Day 30 | 1.67 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2, Day 60 | 1.76 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1, Day 0 | 1.84 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2, Day 60 | 2.09 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1, Day 0 | 1.99 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1 (Day 0 H6) | 2.07 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1 (Day 0 H12) | 2.39 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1 (Day 0 H18) | 3.08 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1, Day 1 | 1.94 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 1, Day 7 | 1.97 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2, Day 30 | 1.97 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2 (Day 30 H6) | 2.11 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2 (Day 30 H12) | 2.35 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2 (Day 30 H18) | 2.99 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2, Day 31 | 2.01 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 1 | Lymphocytes, Dose 2, Day 37 | 2.01 billion cells/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D0 | 2.13 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D30 | 2.14 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D32 | 1.7 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D37 | 2.12 billion cells/L |
| HBsAg/AS_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D60 | 2.12 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D210 | 1.91 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D0 | 1.96 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D180 | 1.93 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D182 | 2.04 billion cells/L |
| Engerix-B_1 Group | Levels of Lymphocytes in Blood Samples - Step 2 | Lymphocytes, D187 | 2.07 billion cells/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1 (Day 0 H12) | 0.79 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2 (Day 30 H6) | 0.67 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1, Day 1 | 0.72 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2 (Day 30 H12) | 0.66 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1 (Day 0 H6) | 0.67 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2 (Day 30 H18) | 0.8 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1, Day 7 | 0.54 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2, Day 31 | 0.67 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1 (Day 0 H18) | 0.79 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2, Day 37 | 0.51 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2, Day 30 | 0.55 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2, Day 60 | 0.51 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1, Day 0 | 0.55 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2, Day 60 | 0.52 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1, Day 0 | 0.55 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1 (Day 0 H6) | 0.52 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1 (Day 0 H12) | 0.53 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1 (Day 0 H18) | 0.59 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1, Day 1 | 0.45 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 1, Day 7 | 0.44 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2, Day 30 | 0.5 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2 (Day 30 H6) | 0.48 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2 (Day 30 H12) | 0.51 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2 (Day 30 H18) | 0.49 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2, Day 31 | 0.51 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 1 | Monocytes, Dose 2, Day 37 | 0.51 billion cells/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D0 | 0.64 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D30 | 0.54 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D32 | 0.87 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D37 | 0.47 billion cells/L |
| HBsAg/AS_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D60 | 0.58 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D210 | 0.52 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D0 | 0.5 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D180 | 0.46 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D182 | 0.43 billion cells/L |
| Engerix-B_1 Group | Levels of Monocytes in Blood Samples - Step 2 | Monocytes, D187 | 0.44 billion cells/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1 (Day 0 H12) | 7.61 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2 (Day 30 H6) | 5.9 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1, Day 1 | 6.13 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2 (Day 30 H12) | 7.07 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1 (Day 0 H6) | 6.48 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2 (Day 30 H18) | 7.42 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1, Day 7 | 4.17 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2, Day 31 | 6.32 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1 (Day 0 H18) | 6.07 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2, Day 37 | 3.64 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2, Day 30 | 3.66 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2, Day 60 | 3.96 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1, Day 0 | 3.7 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2, Day 60 | 2.95 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1, Day 0 | 3.36 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1 (Day 0 H6) | 4.12 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1 (Day 0 H12) | 3.39 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1 (Day 0 H18) | 3.61 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1, Day 1 | 3.76 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 1, Day 7 | 3.46 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2, Day 30 | 2.91 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2 (Day 30 H6) | 3.39 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2 (Day 30 H12) | 3.36 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2 (Day 30 H18) | 3.02 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2, Day 31 | 3.2 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 1 | Neutrophils, Dose 2, Day 37 | 3.13 billion cells/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D0 | 4.02 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D30 | 3.41 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D32 | 3.42 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D37 | 3.22 billion cells/L |
| HBsAg/AS_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D60 | 4.18 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D210 | 3.28 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D0 | 3.11 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D180 | 3.29 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D182 | 3.16 billion cells/L |
| Engerix-B_1 Group | Levels of Neutrophils in Blood Samples - Step 2 | Neutrophils, D187 | 3.9 billion cells/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1 (Day 0 H12) | 4.42 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2 (Day 30 H6) | 4.43 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1, Day 1 | 4.48 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2 (Day 30 H12) | 4.33 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1 (Day 0 H6) | 4.45 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2 (Day 30 H18) | 4.22 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1, Day 7 | 4.54 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2, Day 31 | 4.42 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1 (Day 0 H18) | 4.19 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2, Day 37 | 4.5 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2, Day 30 | 4.48 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2, Day 60 | 4.5 trillion cells/L |
| HBsAg/AS_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1, Day 0 | 4.51 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2, Day 60 | 4.61 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1, Day 0 | 4.56 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1 (Day 0 H6) | 4.58 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1 (Day 0 H12) | 4.51 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1 (Day 0 H18) | 4.36 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1, Day 1 | 4.62 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 1, Day 7 | 4.54 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2, Day 30 | 4.53 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2 (Day 30 H6) | 4.49 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2 (Day 30 H12) | 4.46 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2 (Day 30 H18) | 4.34 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2, Day 31 | 4.58 trillion cells/L |
| Engerix-B_1 Group | Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 | RBC, Dose 2, Day 37 | 4.52 trillion cells/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0 H1.5) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0 H6) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0 H12) | 13.5 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0 H18) | 13 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H1.5) | 13 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H3) | 13 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H6) | 12.5 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H9) | 13 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H12) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D1) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D2) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D7) | 13.5 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H1.5) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H3) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H6) | 13 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H9) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H12) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H18) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D31) | 13 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D32) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D33) | 13 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D37) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D60) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H18) | 13 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-29) | 13.5 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-28) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-27) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-23) | 14 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-28) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0 H1.5) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H6) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0 H6) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D60) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0 H12) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H9) | 13.5 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H12) | 14.5 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30) | 13 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H12) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H1.5) | 14.5 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-23) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H3) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H18) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H6) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H18) | 12 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-30 H9) | 15 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D31) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0 H18) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-27) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D1) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D32) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D2) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, placebo (D-29) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D7) | 13 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D33) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 1 (D0) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H1.5) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D37) | 14 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 1 | Respiratory Rate, Dose 2 (D30 H3) | 14 breaths/min |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, PRE | 12 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D30 H0 | 12.5 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D30 H6 | 12 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D31 | 13 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D32 | 12 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D37 | 13.5 breaths/min |
| HBsAg/AS_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D60 | 12 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D210 | 13.5 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, PRE | 12 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D180 H0 | 12.5 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D180 H6 | 12.5 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D181 | 12 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D182 | 13 breaths/min |
| Engerix-B_1 Group | Levels of Respiratory Rate - Step 2 | Respiratory rate, D187 | 13 breaths/min |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, PRE | 5.55 mg/L |
| HBsAg/AS_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D2 | 24.2 mg/L |
| HBsAg/AS_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D30 | 6.8 mg/L |
| HBsAg/AS_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D31 | 20.45 mg/L |
| HBsAg/AS_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D32 | 33.75 mg/L |
| HBsAg/AS_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D37 | 6.7 mg/L |
| HBsAg/AS_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D60 | 5 mg/L |
| Engerix-B_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D187 | 5 mg/L |
| Engerix-B_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, PRE | 5.8 mg/L |
| Engerix-B_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D210 | 5 mg/L |
| Engerix-B_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D2 | 5 mg/L |
| Engerix-B_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D180 | 5.25 mg/L |
| Engerix-B_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D181 | 5 mg/L |
| Engerix-B_1 Group | Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 | CRP, D182 | 5 mg/L |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1 (Day 0 H12) | 0.78 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2 (Day 30 H6) | 0.75 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1, Day 1 | 0.74 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2 (Day 30 H12) | 0.76 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1 (Day 0 H6) | 0.75 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2 (Day 30 H18) | 0.74 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1, Day 7 | 0.81 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2, Day 31 | 0.79 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1 (Day 0 H18) | 0.7 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2, Day 37 | 0.81 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2, Day 30 | 0.82 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2, Day 60 | 0.84 mg/dL |
| HBsAg/AS_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1, Day 0 | 0.8 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2, Day 60 | 0.78 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1, Day 0 | 0.79 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1 (Day 0 H6) | 0.72 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1 (Day 0 H12) | 0.73 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1 (Day 0 H18) | 0.71 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1, Day 1 | 0.77 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 1, Day 7 | 0.76 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2, Day 30 | 0.79 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2 (Day 30 H6) | 0.73 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2 (Day 30 H12) | 0.72 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2 (Day 30 H18) | 0.73 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2, Day 31 | 0.76 mg/dL |
| Engerix-B_1 Group | Levels of Serum Creatinine in Blood Samples - Step 1 | Creatinine, Dose 2, Day 37 | 0.73 mg/dL |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0) | 118 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D33) | 116 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0 H1.5) | 116 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H9) | 120.5 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0 H6) | 117 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30) | 123.5 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0 H12) | 115 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H12) | 116 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0 H18) | 112 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H12) | 121.5 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H18) | 109.5 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D37) | 120 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H18) | 111 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D60) | 120 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H1.5) | 117 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-29) | 116.5 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D1) | 114 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D32) | 116 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D2) | 115 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-28) | 121 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D7) | 116 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30) | 115 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H3) | 117.5 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H1.5) | 115 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-27) | 119 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H3) | 116 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D31) | 114 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H6) | 117 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-23) | 118 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H9) | 117 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H6) | 118 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0 H12) | 114 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H12) | 116.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H18) | 107 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D31) | 109.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D32) | 110.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30) | 116 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H1.5) | 114 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H3) | 114 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H6) | 112 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H9) | 114.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H12) | 112 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-30 H18) | 106 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-29) | 112 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-28) | 114 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-27) | 115.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, placebo (D-23) | 115 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0) | 114 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0 H1.5) | 109 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0 H6) | 112 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D0 H18) | 105 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D33) | 111.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D37) | 112 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D60) | 115 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D7) | 113 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D1) | 114 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 1 (D2) | 111 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30) | 112.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H1.5) | 109.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H3) | 113 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H6) | 112 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 1 | Systolic, Dose 2 (D30 H9) | 116 mmHg |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D37 | 108.5 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, PRE | 114 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D30 H0 | 114 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D30 H6 | 116 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D31 | 112 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D32 | 111.5 mmHg |
| HBsAg/AS_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D60 | 113 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D210 | 112 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D180 H0 | 111.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, PRE | 112 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D180 H6 | 111.5 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D181 | 115 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D182 | 117 mmHg |
| Engerix-B_1 Group | Levels of Systolic Pressure - Step 2 | Systolic, D187 | 112 mmHg |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1 (Day 0 H12) | 0.4 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1 (Day 0 H18) | 0.6 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1, Day 1 | 0.7 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1, Day 7 | 0.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2, Day 30 | 0.6 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2 (Day 30 H6) | 0.4 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2 (Day 30 H12) | 0.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2 (Day 30 H18) | 0.6 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2, Day 31 | 0.7 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2, Day 37 | 0.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2, Day 60 | 0.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1, Day 0 | 0.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1 (Day 0 H6) | 0.4 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2, Day 60 | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2 (Day 30 H18) | 0.45 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1 (Day 0 H18) | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1 (Day 0 H6) | 0.4 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1, Day 1 | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2, Day 31 | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1, Day 7 | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1, Day 0 | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2, Day 30 | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2, Day 37 | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2 (Day 30 H6) | 0.4 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 1 (Day 0 H12) | 0.3 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 1 | Total bilirubin, Dose 2 (Day 30 H12) | 0.4 mg/dL |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, PRE | 0.4 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D2 | 0.45 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D30 | 0.45 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D31 | 0.55 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D32 | 0.4 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D37 | 0.45 mg/dL |
| HBsAg/AS_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D60 | 0.4 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D187 | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, PRE | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D210 | 0.6 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D2 | 0.5 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D180 | 0.45 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D181 | 0.6 mg/dL |
| Engerix-B_1 Group | Levels of Total Bilirubin in Blood Samples - Step 2 | Total Bilirubin, D182 | 0.6 mg/dL |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1 (Day 0 H12) | 27 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2 (Day 30 H6) | 29 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1, Day 1 | 23.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2 (Day 30 H12) | 28 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1 (Day 0 H6) | 27 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2 (Day 30 H18) | 25.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1, Day 7 | 27.5 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2, Day 31 | 23 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1 (Day 0 H18) | 23 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2, Day 37 | 26 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2, Day 30 | 28 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2, Day 60 | 29 mg/dL |
| HBsAg/AS_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1, Day 0 | 27.5 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2, Day 60 | 27 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1, Day 0 | 30 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1 (Day 0 H6) | 30 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1 (Day 0 H12) | 29 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1 (Day 0 H18) | 27 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1, Day 1 | 25 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 1, Day 7 | 27 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2, Day 30 | 26 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2 (Day 30 H6) | 26 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2 (Day 30 H12) | 27 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2 (Day 30 H18) | 24.5 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2, Day 31 | 26 mg/dL |
| Engerix-B_1 Group | Levels of Urea in Blood Samples - Step 1 | Urea Nitrogen, Dose 2, Day 37 | 25.5 mg/dL |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1 (Day 0 H12) | 10.45 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2 (Day 30 H6) | 9.28 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1, Day 1 | 8.7 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2 (Day 30 H12) | 9.88 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1 (Day 0 H6) | 9.73 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2 (Day 30 H18) | 9.57 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1, Day 7 | 6.67 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2, Day 31 | 8.21 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1 (Day 0 H18) | 8.72 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2, Day 37 | 5.7 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2, Day 30 | 6.04 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2, Day 60 | 6.48 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1, Day 0 | 6.25 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2, Day 60 | 6.07 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1, Day 0 | 6.33 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1 (Day 0 H6) | 6.49 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1 (Day 0 H12) | 6.84 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1 (Day 0 H18) | 7.43 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1, Day 1 | 6.25 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 1, Day 7 | 6.14 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2, Day 30 | 5.77 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2 (Day 30 H6) | 6.07 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2 (Day 30 H12) | 6.28 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2 (Day 30 H18) | 6.8 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2, Day 31 | 6.34 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cells (WBC) - Step 1 | WBC, Dose 2, Day 37 | 6.25 billion cells/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, PRE | 6.93 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, D30 | 6.41 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, D32 | 6.29 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, D37 | 6.37 billion cells/L |
| HBsAg/AS_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, D60 | 7.03 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, D210 | 5.91 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, PRE | 5.67 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, D180 | 6.02 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, D182 | 6.15 billion cells/L |
| Engerix-B_1 Group | Levels of White Blood Cell (WBC) in Blood Samples - Step 2 | WBC, D187 | 7.35 billion cells/L |
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.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Redness, Dose 1 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Pain, Dose 2 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Swelling, Dose 1 | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Redness, Dose 2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Pain, Dose 1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Redness, Dose 2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Pain, Across doses | 31 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Swelling, Dose 1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Pain, Across doses | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Swelling, Dose 2 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Redness, Across doses | 12 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Redness, Dose 1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Redness, Across doses | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Swelling, Dose 2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Swelling, Across doses | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Pain, Dose 2 | 25 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Swelling, Across doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Pain, Dose 1 | 28 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Swelling, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Pain, Across doses | 12 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Pain, Across doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Redness, Across doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Redness, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Swelling, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Swelling, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Pain, Dose 1 | 10 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Pain, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Redness, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Redness, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Swelling, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Swelling, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Pain, Dose 2 | 7 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Pain, Dose 2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Redness, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Redness, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Swelling, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Swelling, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Pain, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Pain, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Redness, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Grade 3 Redness, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step | Any Swelling, Dose 3 | 0 Participants |
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.
Time frame: During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 pain, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any pain, D2 | 15 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any pain, D1 | 18 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 pain, D2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 redness, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any redness, D2 | 5 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any swelling, Across Doses | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 redness, D2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 pain, D1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any swelling, D2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any pain, PP | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 swelling, D2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any redness, D1 | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any pain, Across Doses | 21 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any swelling, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 pain, Across Doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 redness, D1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any redness, Across Doses | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any redness, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 redness, Across Doses | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any swelling, D1 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 swelling, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 swelling, Across Doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 swelling, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any redness, D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any pain, PP | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 pain, PP | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any redness, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 redness, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any swelling, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 swelling, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any pain, D1 | 7 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 pain, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any redness, D1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 redness, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any swelling, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 swelling, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any pain, D2 | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 pain, D2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 redness, D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any swelling, D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 swelling, D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any pain, Across Doses | 8 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 pain, Across Doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any redness, Across Doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 redness, Across Doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Any swelling, Across Doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 | Grade 3 swelling, Across Doses | 0 Participants |
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.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Redness, Dose 1 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Pain, Dose 2 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Swelling, Dose 1 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Redness, Dose 2 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Pain, Dose 1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Redness, Dose 2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Pain, Across doses | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Swelling, Dose 1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Pain, Across doses | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Swelling, Dose 2 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Redness, Across doses | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Redness, Dose 1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Redness, Across doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Swelling, Dose 2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Swelling, Across doses | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Pain, Dose 2 | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Swelling, Across doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Pain, Dose 1 | 10 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Swelling, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Pain, Across doses | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Pain, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Redness, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Redness, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Swelling, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Swelling, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Pain, Dose 1 | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Pain, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Redness, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Redness, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Swelling, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Swelling, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Pain, Dose 2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Pain, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Redness, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Redness, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Swelling, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Swelling, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Pain, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Pain, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Redness, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Grade 3 Redness, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 | Any Swelling, Dose 3 | 0 Participants |
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).
Time frame: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Myalgia, Dose 2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Shivering, Across doses | 16 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Myalgia, Dose 2 | 19 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Gastrointestinal Symptoms, Dose 1 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Shivering, Dose 2 | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Malaise, Dose 1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Shivering, Dose 2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Shivering, Dose 1 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Shivering, Dose 2 | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Gastrointestinal Symptoms, Dose 1 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Shivering, Dose 1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Malaise, Dose 1 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Shivering, Dose 1 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Headache, Dose 1 | 21 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Fatigue, Dose 2 | 17 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Myalgia, Dose 1 | 17 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Fatigue, Dose 2 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Fatigue, Dose 1 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Fatigue, Dose 2 | 17 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Myalgia, Dose 1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Gastrointestinal Symptoms, Dose 2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Myalgia, Across doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Gastrointestinal Symptoms, Dose 2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Headache, Dose 1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Gastrointestinal Symptoms, Dose 2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Myalgia, Across doses | 22 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Headache, Dose 2 | 20 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Gastrointestinal Symptoms, Dose 1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Fatigue, Across doses | 18 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Headache, Dose 2 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Fatigue, Across doses | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Myalgia, Dose 1 | 16 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Fatigue, Across doses | 18 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Headache, Dose 2 | 20 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Gastrointestinal Symptoms, Across doses | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Headache, Dose 1 | 18 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Gastrointestinal Symptoms, Across doses | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Malaise, Dose 2 | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Gastrointestinal Symptoms, Across doses | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Shivering, Across doses | 16 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Headache, Across doses | 26 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Malaise, Dose 2 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Headache, Across doses | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Fatigue, Dose 1 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Headache, Across doses | 24 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Malaise, Dose 2 | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Malaise, Across doses | 15 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Shivering, Across doses | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Malaise, Across doses | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Myalgia, Dose 2 | 19 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Malaise, Across doses | 15 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Malaise, Dose 1 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Myalgia, Across doses | 23 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Fatigue, Dose 1 | 11 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Myalgia, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Myalgia, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Myalgia, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Shivering, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Shivering, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Shivering, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Fatigue, Across doses | 12 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Fatigue, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Fatigue, Across doses | 11 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Gastrointestinal Symptoms, Across doses | 12 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Gastrointestinal Symptoms, Across doses | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Gastrointestinal Symptoms, Across doses | 11 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Headache, Across doses | 11 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Headache, Across doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Headache, Across doses | 10 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Malaise, Across doses | 7 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Malaise, Across doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Malaise, Across doses | 7 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Myalgia, Across doses | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Fatigue, Dose 1 | 9 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Fatigue, Dose 1 | 8 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Gastrointestinal Symptoms, Dose 1 | 9 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Gastrointestinal Symptoms, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Gastrointestinal Symptoms, Dose 1 | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Headache, Dose 1 | 9 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Headache, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Headache, Dose 1 | 7 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Malaise, Dose 1 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Malaise, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Malaise, Dose 1 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Myalgia, Dose 1 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Myalgia, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Myalgia, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Myalgia, Across doses | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Shivering, Across doses | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Shivering, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Shivering, Across doses | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Myalgia, Dose 1 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Shivering, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Shivering, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Shivering, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Fatigue, Dose 2 | 9 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Fatigue, Dose 2 | 8 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Gastrointestinal Symptoms, Dose 2 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Gastrointestinal Symptoms, Dose 2 | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Gastrointestinal Symptoms, Dose 2 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Headache, Dose 2 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Headache, Dose 2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Headache, Dose 2 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Malaise, Dose 2 | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Malaise, Dose 2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Malaise, Dose 2 | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Myalgia, Dose 2 | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Myalgia, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Myalgia, Dose 2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Shivering, Dose 2 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Shivering, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Shivering, Dose 2 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Fatigue, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Fatigue, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Fatigue, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Gastrointestinal Symptoms, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Gastrointestinal Symptoms, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Gastrointestinal Symptoms, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Headache, Dose 3 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Headache, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Headache, Dose 3 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Any Malaise, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Grade 3 Malaise, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step | Related Malaise, Dose 3 | 0 Participants |
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
Time frame: During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any Fatigue, D2 | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related malaise, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 fatigue, D2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 fatigue, D1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related fatigue, D2 | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any headache, PP | 11 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any gastrointestinal symptoms, D2 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related fatigue, D1 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 gastrointestinal symptoms, D2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any myalgia, PP | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related gastrointestinal symptoms, D2 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any gastrointestinal symptoms, D1 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any headache, D2 | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related fatigue, PP | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 headache, D2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 gastrointestinal symptoms, D1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related headache, D2 | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 myalgia, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any malaise, D2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related gastrointestinal symptoms, D1 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 malaise, D2 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 headache, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related malaise, D2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any headache, D1 | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any myalgia, D2 | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related myalgia, PP | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 myalgia, D2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 headache, D1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related myalgia, D2 | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 gastrointestinal symptoms, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any shivering, D2 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related headache, D1 | 11 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 shivering, D2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any shivering, PP | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related shivering, D2 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any malaise, D1 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any temperature (≥37.5 °C), D2 | 5 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related headache, PP | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 temperature (> 39.5 °C), D2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 malaise, D1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related temperature, D2 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 shivering, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any Fatigue, Across Doses | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related malaise, D1 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 fatigue, Across Doses | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 fatigue, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related fatigue, Across Doses | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any myalgia, D1 | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any gastrointestinal symptoms, Across Doses | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related shivering, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 gastrointestinal symptoms, Across Doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 myalgia, D1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related gastrointestinal symptoms, Across Doses | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any malaise, PP | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any headache, Across Doses | 17 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related myalgia, D1 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 headache, Across Doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any temperature, PP | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related headache, Across Doses | 15 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any shivering, D1 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any malaise, Across Doses | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related gastrointestinal symptoms, PP | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 malaise, Across Doses | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 shivering, D1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related malaise, Across Doses | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 temperature, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any myalgia, Across Doses | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related shivering, D1 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 myalgia, Across Doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 malaise, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related myalgia, Across Doses | 13 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any temperature (≥37.5 °C), D1 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any shivering, Across Doses | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related temperature, PP | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 shivering, Across Doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 temperature (> 39.5 °C), D1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related shivering, Across Doses | 10 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any gastrointestinal symptoms, PP | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any temperature (≥37.5 °C), Across Doses | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related temperature, D1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 temperature (> 39.5 °C), Across Doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any Fatigue, D1 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related temperature, Across Doses | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any fatigue, PP | 8 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related temperature, Across Doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any fatigue, PP | 12 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 fatigue, PP | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related fatigue, PP | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any gastrointestinal symptoms, PP | 8 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 gastrointestinal symptoms, PP | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related gastrointestinal symptoms, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any headache, PP | 13 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 headache, PP | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related headache, PP | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any malaise, PP | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 malaise, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related malaise, PP | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any myalgia, PP | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 myalgia, PP | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related myalgia, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any shivering, PP | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 shivering, PP | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related shivering, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any temperature, PP | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 temperature, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related temperature, PP | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any Fatigue, D1 | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 fatigue, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related fatigue, D1 | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any gastrointestinal symptoms, D1 | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 gastrointestinal symptoms, D1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related gastrointestinal symptoms, D1 | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any headache, D1 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 headache, D1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related headache, D1 | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any malaise, D1 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 malaise, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related malaise, D1 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any myalgia, D1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 myalgia, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related myalgia, D1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any shivering, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 shivering, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related shivering, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any temperature (≥37.5 °C), D1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 temperature (> 39.5 °C), D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related temperature, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any Fatigue, D2 | 8 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 fatigue, D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related fatigue, D2 | 7 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any gastrointestinal symptoms, D2 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 gastrointestinal symptoms, D2 | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related gastrointestinal symptoms, D2 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any headache, D2 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 headache, D2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related headache, D2 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any malaise, D2 | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 malaise, D2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related malaise, D2 | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any myalgia, D2 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 myalgia, D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related myalgia, D2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any shivering, D2 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 shivering, D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related shivering, D2 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any temperature (≥37.5 °C), D2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 temperature (> 39.5 °C), D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related temperature, D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any Fatigue, Across Doses | 9 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 fatigue, Across Doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related fatigue, Across Doses | 9 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any gastrointestinal symptoms, Across Doses | 8 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 gastrointestinal symptoms, Across Doses | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related gastrointestinal symptoms, Across Doses | 7 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any headache, Across Doses | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 headache, Across Doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related headache, Across Doses | 6 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any malaise, Across Doses | 7 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 malaise, Across Doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related malaise, Across Doses | 7 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any myalgia, Across Doses | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 myalgia, Across Doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related myalgia, Across Doses | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any shivering, Across Doses | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 shivering, Across Doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Related shivering, Across Doses | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Any temperature (≥37.5 °C), Across Doses | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 | Grade 3 temperature (> 39.5 °C), Across Doses | 0 Participants |
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.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Malaise, Dose 1 | 5 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Fatigue, Dose 2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Headache, Dose 1 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Fatigue, Dose 2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Myalgia, Dose 1 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Gastrointestinal Symptoms, Dose 2 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Fatigue, Dose 1 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Gastrointestinal Symptoms, Dose 2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Myalgia, Dose 1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Gastrointestinal Symptoms, Dose 2 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Headache, Dose 1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Headache, Dose 2 | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Myalgia, Dose 1 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Headache, Dose 2 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Gastrointestinal Symptoms, Dose 1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Headache, Dose 2 | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Shivering, Dose 1 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Malaise, Dose 2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Headache, Dose 1 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Malaise, Dose 2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Shivering, Dose 1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Fatigue, Across doses | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Malaise, Dose 2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Fatigue, Across doses | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Fatigue, Dose 1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Fatigue, Across doses | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Myalgia, Dose 2 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Gastrointestinal Symptoms, Across doses | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Shivering, Dose 1 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Gastrointestinal Symptoms, Across doses | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Myalgia, Dose 2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Gastrointestinal Symptoms, Across doses | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Malaise, Dose 1 | 5 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Headache, Across doses | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Myalgia, Dose 2 | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Headache, Across doses | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Temperature, Dose 1 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Headache, Across doses | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Shivering, Dose 2 | 5 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Malaise, Across doses | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Gastrointestinal Symptoms, Dose 1 | 5 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Malaise, Across doses | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Shivering, Dose 2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Malaise, Across doses | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Temperature, Dose 1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Myalgia, Across doses | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Shivering, Dose 2 | 5 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Myalgia, Across doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Malaise, Dose 1 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Myalgia, Across doses | 9 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Temperature, Dose 2 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Shivering, Across doses | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Temperature, Dose 1 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Shivering, Across doses | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Temperature, Dose 2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Shivering, Across doses | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Gastrointestinal Symptoms, Dose 1 | 5 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Temperature, Across doses | 6 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Temperature, Dose 2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Temperature, Across doses | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Fatigue, Dose 2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Temperature, Across doses | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Fatigue, Dose 1 | 8 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Temperature, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Fatigue, Across doses | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Fatigue, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Fatigue, Across doses | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Gastrointestinal Symptoms, Across doses | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Gastrointestinal Symptoms, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Gastrointestinal Symptoms, Across doses | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Headache, Across doses | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Headache, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Headache, Across doses | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Malaise, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Malaise, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Malaise, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Myalgia, Across doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Myalgia, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Myalgia, Across doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Shivering, Across doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Shivering, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Shivering, Across doses | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Temperature, Across doses | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Temperature, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Temperature, Across doses | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Fatigue, Dose 1 | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Fatigue, Dose 1 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Gastrointestinal Symptoms, Dose 1 | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Gastrointestinal Symptoms, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Gastrointestinal Symptoms, Dose 1 | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Headache, Dose 1 | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Headache, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Headache, Dose 1 | 3 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Malaise, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Malaise, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Malaise, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Myalgia, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Myalgia, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Myalgia, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Shivering, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Shivering, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Shivering, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Temperature, Dose 1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Temperature, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Temperature, Dose 1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Fatigue, Dose 2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Fatigue, Dose 2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Gastrointestinal Symptoms, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Gastrointestinal Symptoms, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Gastrointestinal Symptoms, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Headache, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Headache, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Headache, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Malaise, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Malaise, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Malaise, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Myalgia, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Myalgia, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Myalgia, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Shivering, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Shivering, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Shivering, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Temperature, Dose 2 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Temperature, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Temperature, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Fatigue, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Fatigue, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Fatigue, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Gastrointestinal Symptoms, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Gastrointestinal Symptoms, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Gastrointestinal Symptoms, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Headache, Dose 3 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Headache, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Headache, Dose 3 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Malaise, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Malaise, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Malaise, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Myalgia, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Myalgia, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Myalgia, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Shivering, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Shivering, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Related Shivering, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Any Temperature, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 | Grade 3 Temperature, Dose 3 | 0 Participants |
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.
Time frame: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step | 1 Participants |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1 | MAEs - Day 60 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1 | MAEs - Day 210 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1 | MAEs - Day 60 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1 | MAEs - Day 210 | 1 Participants |
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.
Time frame: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2 | 0 Participants |
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.
Time frame: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step | 0 Participants |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1 | pIMDs - Day 60 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1 | pIMDs - Day 210 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1 | pIMDs - Day 60 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1 | pIMDs - Day 210 | 0 Participants |
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.
Time frame: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2 | 0 Participants |
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.
Time frame: Within the 28-day (Days 0-27) post-vaccination period.
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step | 20 Participants |
| Engerix-B_1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step | 19 Participants |
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.
Time frame: Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period.
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1 | Any AEs, post-placebo | 12 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1 | Any AEs, post-product administration | 14 Participants |
| Engerix-B_1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1 | Any AEs, post-placebo | 16 Participants |
| Engerix-B_1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1 | Any AEs, post-product administration | 15 Participants |
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.
Time frame: Within the 28-day (Days 0-27) and post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2 | 4 Participants |
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.
Time frame: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step | 1 Participants |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Serious Adverse Events (SAEs) - Step 1 | Day 60 SAEs | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Serious Adverse Events (SAEs) - Step 1 | Day 210 SAEs | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Serious Adverse Events (SAEs) - Step 1 | Day 60 SAEs | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Serious Adverse Events (SAEs) - Step 1 | Day 210 SAEs | 1 Participants |
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.
Time frame: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Serious Adverse Events (SAEs) - Step 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Serious Adverse Events (SAEs) - Step 2 | 0 Participants |
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.
Time frame: Up to 3 days post-Dose 2 vaccine administration in HBsAg/AS_1+2 Group
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step | Pain | 26 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step | Redness | 12 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step | Swelling | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step | Induration | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step | Muscle stiffness | 22 Participants |
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.
Time frame: Up to 4 days post-placebo/vaccine administration.
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Fever (≥37.5), placebo | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Fever (≥37.5), D1 | 2 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Fever (≥37.5), D2 | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Pain, placebo | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Pain, D1 | 19 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Pain, D2 | 19 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Redness, placebo | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Redness, D1 | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Redness, D2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Induration, placebo | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Induration, D1 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Induration, D2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Swelling, placebo | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Swelling, D1 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Swelling, D2 | 4 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Muscle stiffness, placebo | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Muscle stiffness, D1 | 14 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Muscle stiffness, D2 | 15 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Swelling, D1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Fever (≥37.5), placebo | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Induration, placebo | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Fever (≥37.5), D1 | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Muscle stiffness, D2 | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Fever (≥37.5), D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Induration, D1 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Pain, placebo | 4 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Swelling, D2 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Pain, D1 | 9 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Induration, D2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Pain, D2 | 8 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Muscle stiffness, D1 | 5 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Redness, placebo | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Swelling, placebo | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Redness, D1 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Muscle stiffness, placebo | 2 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 | Redness, D2 | 0 Participants |
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.
Time frame: Up to 3 days post-placebo/vaccine administration.
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Pain, Dose 2 | 8 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Pain, Dose 3 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Redness, Dose 2 | 5 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Redness, Dose 3 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Swelling, Dose 2 | 3 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Swelling, Dose 3 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Induration, Dose 2 | 1 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Induration, Dose 3 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Fever, Dose 2 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Fever, Dose 3 | 0 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Muscle stiffness, Dose 2 | 7 Participants |
| HBsAg/AS_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Muscle stiffness, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Muscle stiffness, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Pain, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Induration, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Pain, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Fever, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Redness, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Induration, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Redness, Dose 3 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Muscle stiffness, Dose 3 | 1 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Swelling, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Fever, Dose 2 | 0 Participants |
| Engerix-B_1 Group | Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 | Swelling, Dose 3 | 0 Participants |
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.
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1 (Day 0 H12) | 235 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1 (Day 0 H18) | 222 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1, Day 1 | 220.5 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1, Day 7 | 263.5 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2, Day 30 | 224 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2 (Day 30 H6) | 238 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2 (Day 30 H12) | 226 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2 (Day 30 H18) | 230.5 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2, Day 31 | 218 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2, Day 37 | 253 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2, Day 60 | 240 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1, Day 0 | 228 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1 (Day 0 H6) | 229 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2, Day 60 | 241.5 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2 (Day 30 H18) | 229 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1 (Day 0 H18) | 233 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1 (Day 0 H6) | 231 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1, Day 1 | 227 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2, Day 31 | 217.5 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1, Day 7 | 247 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1, Day 0 | 225 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2, Day 30 | 228 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2, Day 37 | 243 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2 (Day 30 H6) | 232 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 1 (Day 0 H12) | 230 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 1 | Platelets, Dose 2 (Day 30 H12) | 234 billion cells/L |
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).
Time frame: 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D0 | 269 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D30 | 272.5 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D32 | 257 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D37 | 315.5 billion cells/L |
| HBsAg/AS_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D60 | 282 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D210 | 264.5 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D0 | 272 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D180 | 247 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D182 | 263 billion cells/L |
| Engerix-B_1 Group | Platelet Count in Blood Samples - Step 2 | Platelets, D187 | 272 billion cells/L |