Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01777295
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Collaborators:
Region of Wallonia
Public Private Partnership with Institute for Medical Immunology (Universite Libre de Bruxelles)
Information provided by (Responsible Party):
GlaxoSmithKline

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.


Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A. Biological: EngerixTM-B Biological: Placebo Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Development of Read-outs to Detect and Characterise the Early and Adaptive Immune Responses in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen in Combination With a GSK Biologicals' Adjuvant System
Actual Study Start Date : February 25, 2013
Actual Primary Completion Date : May 17, 2016
Actual Study Completion Date : September 13, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HBsAg/AS Group
Subjects in this group received 1 dose of Placebo at Day -30 followed by 2 doses of HBsAg/AS, at Day 0 and Day 30.
Biological: Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Other Name: HBsAg/AS

Biological: Placebo
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Active Comparator: Engerix-B Group
Subjects in this group received 1 dose of Placebo at Day -30 followed by 3 doses of Engerix-B at Day 0, Day 30 and Day 180.
Biological: EngerixTM-B
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Other Name: Engerix-B

Biological: Placebo
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.




Primary Outcome Measures :
  1. Concentrations of Cytokines and Chemokines - Step 1 [ Time Frame: 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.

  2. Cytokines and Chemokines Concentrations - Step 1 [ Time Frame: 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.

  3. Concentrations of Cytokines and Chemokines in Step 1 [ Time Frame: 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.

  4. Concentrations of Cytokines and Chemokines During Step 1 [ Time Frame: 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.

  5. Concentrations of Cytokines/Chemokines - Step 1 [ Time Frame: 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.

  6. Concentrations of Cytokines/Chemokines in Step 1 [ Time Frame: 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.

  7. Concentrations of Cytokines/Chemokines During Step 1 [ Time Frame: 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.

  8. Cytokines and Chemokines Concentrations in Step 1 [ Time Frame: 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.

  9. Cytokines and Chemokines Concetrations During Step 1 [ Time Frame: 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.

  10. Cytokines/Chemokines Concentrations in Step 1 [ Time Frame: 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.

  11. Cytokines and Chemokines Concentrations During Step 1 [ Time Frame: 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.

  12. Concentrations of Cytokines and Chemokines - Study Step 1 [ Time Frame: 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.

  13. Concentrations of Cytokines and Chemokines in Step 1 of Study [ Time Frame: 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.

  14. Concentrations of Cytokines and Chemokines During Step 1 of Study [ Time Frame: 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.

  15. Cytokines and Chemokines Concentrations - Study Step 1 [ Time Frame: 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.

  16. Cytokines and Chemokines Concentrations in Step 1 of Study [ Time Frame: 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.

  17. Cytokines and Chemokines Concentrations During Step 1 of Study [ Time Frame: 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.

  18. Cytokines/Chemokines Concentrations - Study Step 1 [ Time Frame: 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.

  19. Cytokines/Chemokines Concentrations in Step 1 of Study [ Time Frame: 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.

  20. Cytokines/Chemokines Concentrations During Step 1 of Study [ Time Frame: 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.

  21. Plasma Concentrations of Cytokines and Chemokines - Step 1 [ Time Frame: 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.

  22. Plasma Concentrations of Cytokines and Chemokines - Study Step 1 [ Time Frame: 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.

  23. Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study [ Time Frame: 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.

  24. Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study [ Time Frame: 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.

  25. Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study [ Time Frame: 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.

  26. Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study [ Time Frame: 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.

  27. Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study [ Time Frame: 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.

  28. Concentrations of Plasma Cytokines and Chemokines - Step 1 [ Time Frame: 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.

  29. Concentrations of Plasma Cytokines and Chemokines in Step 1 [ Time Frame: 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.

  30. Concentrations of Plasma Cytokines and Chemokines During Step 1 [ Time Frame: 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.

  31. Concentrations of Cytokines and Chemokines - Step 2 [ Time Frame: 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.

  32. Cytokines and Chemokines Concentrations - Step 2 [ Time Frame: 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.

  33. Concentrations of Cytokines and Chemokines During Step 2 [ Time Frame: 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.

  34. Concentrations of Cytokines and Chemokines in Step 2 [ Time Frame: 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.

  35. Concentrations of Cytokines/Chemokines - Step 2 [ Time Frame: 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.

  36. Concentrations of Cytokines/Chemokines in Step 2 [ Time Frame: 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.


  37. Concentrations of Cytokines/Chemokines During Step 2 [ Time Frame: 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.


  38. Plasma Concentrations of Cytokines and Chemokines - Study Step 2 [ Time Frame: 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.

  39. Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study [ Time Frame: 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.

  40. Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study [ Time Frame: 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 Outcome Measures :
  1. Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1 [ Time Frame: 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).

  2. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1 [ 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 ]
    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.

  3. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1 [ 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 ]
    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

  4. Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1 [ Time Frame: 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.

  5. Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1 [ Time Frame: 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.

  6. Number of Subjects With Serious Adverse Events (SAEs) - Step 1 [ 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 ]
    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.

  7. Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1 [ 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 ]
    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.

  8. Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1 [ 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 ]
    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.

  9. Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1 [ 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 ]
    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.

  10. Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1 [ 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 ]
    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.

  11. Levels of Basophils in Blood Samples - Step 1 [ 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 ]
    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.

  12. Levels of Total Bilirubin in Blood Samples - Step 1 [ 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 ]
    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.

  13. Levels of Serum Creatinine in Blood Samples - Step 1 [ 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 ]
    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.

  14. Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1 [ 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 ]
    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.

  15. Levels of C-reactive Protein (CRP) in Blood Samples - Step 1 [ 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 ]
    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.

  16. Levels of Eosinophils in Blood Samples - Step 1 [ 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 ]
    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.

  17. Levels of Haemoglobin in Blood Samples - Step 1 [ 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 ]
    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.

  18. Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1 [ 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 ]
    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.

  19. Levels of Lymphocytes in Blood Samples - Step 1 [ 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 ]
    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.

  20. Levels of Monocytes in Blood Samples - Step 1 [ 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 ]
    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.

  21. Levels of Neutrophils in Blood Samples - Step 1 [ 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 ]
    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.

  22. Platelet Count in Blood Samples - Step 1 [ 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 ]
    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.

  23. Levels of Red Blood Cell (RBC) in Blood Samples - Step 1 [ 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 ]
    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.

  24. Levels of Urea in Blood Samples - Step 1 [ 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 ]
    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.

  25. Levels of White Blood Cells (WBC) - Step 1 [ 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 ]
    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.

  26. Levels of Diastolic Blood Pressure - Step 1 [ 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 ]
    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).

  27. Levels of Heart Rate - Step 1 [ 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 ]
    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).

  28. Levels of Respiratory Rate - Step 1 [ 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 ]
    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).

  29. Levels of Systolic Pressure - Step 1 [ 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 ]
    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).

  30. Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno [ Time Frame: 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).

  31. Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence [ Time Frame: 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).

  32. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2 [ Time Frame: 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.

  33. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step [ Time Frame: 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.

  34. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2 [ Time Frame: 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.

  35. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step [ Time Frame: 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).

  36. Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2 [ Time Frame: 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.

  37. Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step [ Time Frame: 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.

  38. Number of Subjects With Serious Adverse Events (SAEs) - Step 2 [ Time Frame: 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.

  39. Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step [ 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 ]
    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.

  40. Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2 [ Time Frame: 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.

  41. Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step [ 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 ]
    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.

  42. Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2 [ Time Frame: 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.

  43. Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step [ 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 ]
    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.

  44. Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2 [ 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 ]
    Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L).

  45. Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2 [ 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 ]
    Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L).

  46. Levels of Basophils in Blood Samples - Step 2 [ 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 ]
    Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L).

  47. Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2 [ 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 ]
    Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L).

  48. Levels of Eosinophils in Blood Samples - Step 2 [ 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 ]
    Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L).

  49. Levels of White Blood Cell (WBC) in Blood Samples - Step 2 [ 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 ]
    Haematological laboratory parameters assessed included white blood cells levels. WBC levels were expressed in billion cells per liter (billion cells/L).

  50. Levels of Lymphocytes in Blood Samples - Step 2 [ 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 ]
    Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L).

  51. Levels of Monocytes in Blood Samples - Step 2 [ 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 ]
    Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L).

  52. Levels of Neutrophils in Blood Samples - Step 2 [ 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 ]
    Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L).

  53. Platelet Count in Blood Samples - Step 2 [ 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 ]
    Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L).

  54. Levels of Total Bilirubin in Blood Samples - Step 2 [ 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 ]
    Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL).

  55. Levels of Diastolic Blood Pressure - Step 2 [ 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 ]
    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).

  56. Levels of Heart Rate - Step 2 [ 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 ]
    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).

  57. Levels of Respiratory Rate - Step 2 [ 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 ]
    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).

  58. Levels of Systolic Pressure - Step 2 [ 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 ]
    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).

  59. -Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 [ Time Frame: 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).

  60. Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1 [ Time Frame: 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).

  61. Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 [ Time Frame: 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).

  62. Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1 [ Time Frame: 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).

  63. Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2 [ Time Frame: 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.

  64. Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777295


Locations
Layout table for location information
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2060
Sponsors and Collaborators
GlaxoSmithKline
Region of Wallonia
Public Private Partnership with Institute for Medical Immunology (Universite Libre de Bruxelles)
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01777295     History of Changes
Other Study ID Numbers: 116640
2012-001344-22 ( EudraCT Number )
First Posted: January 28, 2013    Key Record Dates
Results First Posted: January 4, 2019
Last Update Posted: January 4, 2019
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Adults
Reactogenicity
Naive
Immune responses
Read-outs
Hepatitis B
Healthy
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections