CompletedNCT01777295Updated Jan 4, 2019Results posted

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

A Phase 2 interventional study of Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A. and EngerixTM-B in Hepatitis B, sponsored by GlaxoSmithKline. Completed at 1 site in Belgium. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-04.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 81
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Hepatitis B

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Keywords

Adults
Reactogenicity
Naive
Immune responses
Read-outs
Hepatitis B
Healthy

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 81 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 81 participants (actual)

Study arms

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. · Biological: Placebo
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 · Biological: Placebo

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.
Also known as: HBsAg/AS
BiologicalEngerixTM-B
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Also known as: Engerix-B
BiologicalPlacebo
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

What researchers measure

Primary outcomes

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Secondary outcomes

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
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
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
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
-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
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
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
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
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.
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

Results

Posted Jan 4, 2019

Participant flow

Participant flow — Overall Study
Milestone	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group
Started	40	41
Completed	36	38
Not completed	4	3
Withdrew: Withdrawal by subject	2	2
Withdrew: Pregnancy	0	1
Withdrew: Personal problem	1	0
Withdrew: Investigator call for aes check	1	0

Outcome measures

PrimaryConcentrations 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
Reported as:: Median · pg/mL

Concentrations of Cytokines and Chemokines - Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6000 (4600 to 8300)	6250 (4600 to 7800)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 4.5)	3.3 (3.3 to 4.1)
IL-18	198 (148 to 290)	177 (152 to 215)
IL-2	5.9 (5.9 to 7)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	26000 (20000 to 30000)	22500 (22000 to 30000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.7 (4.2 to 6.6)	5.1 (3.9 to 5.9)
IP-10	225 (176 to 402)	247.5 (195 to 280)
MCP-1	107 (89 to 142)	98.5 (83 to 117)
MCP-2	18 (13 to 25)	19.5 (17 to 26)
MCP-4	1230 (1070 to 1550)	1170 (1100 to 1600)
MIG	513 (354 to 682)	435 (285 to 674)
MIP-1 alpha	20 (18 to 25)	20 (18 to 24)
MIP-1 beta	190 (162 to 228)	138 (126 to 205)
MIP-3 alpha	25 (11 to 32)	18 (11 to 28)
MPIF-1	1600 (1200 to 1800)	1450 (1200 to 1600)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines and Chemokines Concentrations - Step 1

Time frame:: Post-placebo at Day -30 plus 1.5 Hours
Reported as:: Median · pg/mL

Cytokines and Chemokines Concentrations - Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5900 (4100 to 8500)	6450 (4500 to 7600)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.7)	3.3 (3.3 to 3.7)
IL-18	172 (141 to 225)	179.5 (136 to 215)
IL-2	5.9 (5.9 to 7)	5.9 (5.9 to 6.3)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	26000 (21000 to 30000)	22000 (19000 to 29000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.2 (3.7 to 4.9)	4.2 (3.2 to 5.3)
IP-10	220 (183 to 330)	207 (172 to 240)
MCP-1	79 (58 to 101)	77.5 (63 to 96)
MCP-2	17 (13 to 24)	19 (14 to 25)
MCP-4	1300 (933 to 1480)	1190 (896 to 1300)
MIG	392 (344 to 575)	336 (269 to 487)
MIP-1 alpha	18 (18 to 21)	18 (18 to 19)
MIP-1 beta	141 (108 to 191)	124.5 (107 to 151)
MIP-3 alpha	16 (13 to 27)	16 (13 to 22)
MPIF-1	1500 (1200 to 1600)	1400 (1000 to 1600)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Cytokines and Chemokines in Step 1

Time frame:: Post-placebo at Day -30 plus 3 Hours
Reported as:: Median · pg/mL

Concentrations of Cytokines and Chemokines in Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5600 (3800 to 7800)	6300 (4100 to 7600)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 4.2)	3.3 (3.3 to 3.4)
IL-18	168 (154 to 283)	173 (142 to 202)
IL-2	5.9 (5.9 to 7.4)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	28000 (22000 to 34000)	26000 (21000 to 33000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.2 (3.5 to 6.4)	4 (3.2 to 5.3)
IP-10	223 (169 to 396)	217.5 (175 to 251)
MCP-1	79 (65 to 92)	64 (48 to 104)
MCP-2	21 (14 to 27)	20 (18 to 23)
MCP-4	1170 (951 to 1440)	1175 (1060 to 1310)
MIG	439 (347 to 558)	343 (285 to 504)
MIP-1 alpha	18 (18 to 21)	18 (18 to 21)
MIP-1 beta	163 (120 to 199)	127 (112 to 147)
MIP-3 alpha	18 (12 to 27)	18 (14 to 22)
MPIF-1	1600 (1200 to 1900)	1300 (1000 to 1500)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Cytokines and Chemokines During Step 1

Time frame:: Post-placebo at Day -30 plus 6 Hours
Reported as:: Median · pg/mL

Concentrations of Cytokines and Chemokines During Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5200 (3900 to 8300)	6050 (4200 to 8100)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 4.6)	3.3 (3.3 to 3.6)
IL-18	176 (160 to 273)	177.5 (132 to 233)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 6)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 2)	1.6 (1.6 to 1.6)
IL-6r	27000 (21000 to 32000)	24500 (20000 to 33000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.5 (3.7 to 6)	4.5 (3.9 to 5.8)
IP-10	217 (177 to 400)	218 (174 to 252)
MCP-1	104 (76 to 119)	101 (76 to 129)
MCP-2	18 (14 to 24)	20.5 (16 to 23)
MCP-4	1310 (1030 to 1570)	1245 (1110 to 1490)
MIG	500 (320 to 614)	378 (313 to 566)
MIP-1 alpha	18 (18 to 21)	18 (18 to 19)
MIP-1 beta	166 (140 to 215)	146 (129 to 180)
MIP-3 alpha	21 (15 to 26)	20 (15 to 24)
MPIF-1	1500 (1200 to 1800)	1400 (1100 to 1700)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Cytokines/Chemokines - Step 1

Time frame:: Post-placebo at Day -30 plus 9 Hours
Reported as:: Median · pg/mL

Concentrations of Cytokines/Chemokines - Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5300 (3600 to 7100)	6100 (4600 to 7500)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 4.8)	3.3 (3.3 to 3.3)
IL-18	173 (139 to 226)	167.5 (117 to 202)
IL-2	5.9 (5.9 to 14)	5.9 (5.9 to 7.2)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 2.7)	1.6 (1.6 to 1.6)
IL-6r	24000 (19000 to 31000)	26000 (19000 to 29000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.9 (3.7 to 6.9)	4.5 (3.6 to 5.3)
IP-10	210 (162 to 327)	205.5 (159 to 227)
MCP-1	86 (65 to 104)	81 (61 to 109)
MCP-2	17 (15 to 24)	17 (15 to 21)
MCP-4	1310 (1050 to 1610)	1145 (944 to 1400)
MIG	452 (313 to 610)	327 (244 to 528)
MIP-1 alpha	18 (18 to 22)	18 (18 to 18)
MIP-1 beta	131 (111 to 185)	119.5 (102 to 134)
MIP-3 alpha	19 (11 to 25)	15 (11 to 17)
MPIF-1	1400 (1100 to 1800)	1200 (1000 to 1400)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Cytokines/Chemokines in Step 1

Time frame:: Post-placebo at Day -30 plus 12 Hours
Reported as:: Median · pg/mL

Concentrations of Cytokines/Chemokines in Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5200 (3500 to 7900)	5600 (4000 to 7800)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.3)	3.3 (3.3 to 3.3)
IL-18	171 (150 to 244)	180 (131 to 222)
IL-2	5.9 (5.9 to 6.3)	5.9 (5.9 to 6.3)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	26000 (21000 to 32000)	24000 (21000 to 34000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.6 (3.9 to 5.9)	4.5 (3.9 to 5.8)
IP-10	217 (160 to 335)	214 (182 to 246)
MCP-1	117 (79 to 133)	120 (96 to 137)
MCP-2	18 (14 to 26)	19 (17 to 25)
MCP-4	1260 (1000 to 1480)	1160 (997 to 1480)
MIG	460 (344 to 623)	412 (341 to 564)
MIP-1 alpha	18 (18 to 21)	18 (18 to 21)
MIP-1 beta	159 (120 to 179)	137 (118 to 167)
MIP-3 alpha	21 (14 to 26)	22 (17 to 28)
MPIF-1	1400 (1200 to 1700)	1300 (1000 to 1500)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Cytokines/Chemokines During Step 1

Time frame:: Post-placebo at Day -30 plus 18 Hours
Reported as:: Median · pg/mL

Concentrations of Cytokines/Chemokines During Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	4950 (2900 to 6500)	4200 (2700 to 6300)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.6)	3.3 (3.3 to 3.3)
IL-18	174 (118 to 267)	142 (81 to 182)
IL-2	6 (5.9 to 6.3)	5.9 (5.9 to 6)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 2.4)
IL-6r	21500 (18000 to 29000)	21000 (18000 to 28000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.5 (4.6 to 8.2)	6.1 (4.9 to 7.8)
IP-10	243.5 (174 to 386)	238 (170 to 483)
MCP-1	98 (76 to 119)	109 (79 to 132)
MCP-2	18 (12 to 26)	17 (16 to 27)
MCP-4	1445 (1130 to 1640)	1390 (1140 to 1710)
MIG	420 (373 to 636)	458 (340 to 811)
MIP-1 alpha	18 (18 to 26)	18 (18 to 23)
MIP-1 beta	143.5 (136 to 182)	165 (128 to 216)
MIP-3 alpha	30 (21 to 34)	20 (17 to 38)
MPIF-1	1400 (1300 to 1700)	1100 (920 to 1500)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines and Chemokines Concentrations in Step 1

Time frame:: Post-placebo at Day -29
Reported as:: Median · pg/mL

Cytokines and Chemokines Concentrations in Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5900 (4300 to 8500)	6350 (4500 to 8600)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 4.5)	3.3 (3.3 to 3.3)
IL-18	186 (149 to 261)	177.5 (136 to 242)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.7)	1.6 (1.6 to 1.7)
IL-6r	27000 (19000 to 35000)	26500 (19000 to 31000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.4 (3.9 to 6.9)	5.2 (4.3 to 6.8)
IP-10	241 (190 to 345)	244.5 (200 to 307)
MCP-1	93 (73 to 116)	81.5 (66 to 104)
MCP-2	19 (15 to 24)	19 (16 to 25)
MCP-4	1230 (1070 to 1350)	1170 (1020 to 1450)
MIG	528 (327 to 695)	418.5 (352 to 721)
MIP-1 alpha	19 (18 to 24)	18 (18 to 21)
MIP-1 beta	169 (124 to 219)	141.5 (123 to 188)
MIP-3 alpha	22 (17 to 28)	21 (14 to 28)
MPIF-1	1700 (1200 to 1900)	1500 (1100 to 1700)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines and Chemokines Concetrations During Step 1

Time frame:: Post-placebo at Day -28
Reported as:: Median · pg/mL

Cytokines and Chemokines Concetrations During Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5900 (3700 to 7800)	6250 (4300 to 7900)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.9)	3.3 (3.3 to 3.9)
IL-18	182 (148 to 288)	178.5 (120 to 232)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	27000 (20000 to 35000)	25500 (20000 to 28000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.8 (3.7 to 6.5)	4.9 (3.5 to 6.6)
IP-10	270 (205 to 381)	228 (186 to 304)
MCP-1	74 (56 to 112)	73.5 (47 to 90)
MCP-2	19 (13 to 26)	18.5 (15 to 26)
MCP-4	1200 (937 to 1530)	1140 (951 to 1340)
MIG	468 (336 to 568)	397 (292 to 587)
MIP-1 alpha	18 (18 to 21)	18 (18 to 18)
MIP-1 beta	174 (141 to 227)	151.5 (113 to 175)
MIP-3 alpha	20 (15 to 28)	17.5 (11 to 33)
MPIF-1	1500 (1200 to 1800)	1350 (970 to 1600)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines/Chemokines Concentrations in Step 1

Time frame:: Post-placebo at Day -27
Reported as:: Median · pg/mL

Cytokines/Chemokines Concentrations in Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6150 (3700 to 8200)	6250 (4000 to 7200)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.4 (3.3 to 4.5)	3.3 (3.3 to 4.2)
IL-18	183 (157 to 236)	174.5 (139 to 217)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.7)	1.6 (1.6 to 1.7)
IL-6r	26000 (21000 to 32000)	24000 (21000 to 29000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.3 (3.4 to 6.6)	4.2 (3.6 to 5.4)
IP-10	239 (189 to 348)	220.5 (186 to 281)
MCP-1	84.5 (65 to 110)	86.5 (73 to 109)
MCP-2	18.5 (14 to 22)	20 (15 to 25)
MCP-4	1150 (989 to 1270)	1060 (911 to 1360)
MIG	429.5 (349 to 542)	403.5 (300 to 635)
MIP-1 alpha	18 (18 to 23)	18 (18 to 19)
MIP-1 beta	165 (117 to 196)	141 (106 to 181)
MIP-3 alpha	20.5 (18 to 27)	21 (18 to 26)
MPIF-1	1350 (1200 to 1700)	1300 (1100 to 1600)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines and Chemokines Concentrations During Step 1

Time frame:: Post-placebo at Day -23
Reported as:: Median · pg/mL

Cytokines and Chemokines Concentrations During Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5500 (4000 to 8300)	6150 (4700 to 7900)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 4.3)	3.3 (3.3 to 3.5)
IL-18	184 (150 to 247)	176.5 (122 to 208)
IL-2	5.9 (5.9 to 7)	5.9 (5.9 to 7)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	27000 (17000 to 310000)	23500 (19000 to 28000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.5 (3.9 to 6.8)	5 (3.5 to 5.8)
IP-10	241 (190 to 366)	223 (186 to 285)
MCP-1	88 (55 to 143)	72 (66 to 96)
MCP-2	15 (14 to 25)	19 (16 to 23)
MCP-4	1390 (1000 to 1480)	1145 (1000 to 1350)
MIG	391 (337 to 524)	375.5 (286 to 625)
MIP-1 alpha	18 (18 to 22)	18 (18 to 19)
MIP-1 beta	165 (128 to 199)	138.5 (113 to 158)
MIP-3 alpha	21 (13 to 28)	16 (10 to 21)
MPIF-1	1600 (1200 to 1800)	1350 (1000 to 1700)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Cytokines and Chemokines - Study Step 1

Time frame:: Pre-dose1 at Day 0
Reported as:: Median · pg/mL

Concentrations of Cytokines and Chemokines - Study Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6100 (4200 to 9000)	6150 (5000 to 8600)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.5)	3.3 (3.3 to 3.9)
IL-18	169 (151 to 237)	171 (119 to 207)
IL-2	5.9 (5.9 to 6.5)	5.9 (5.9 to 6.5)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	27000 (20000 to 32000)	24500 (22000 to 29000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.9 (4.2 to 6.2)	5 (4.2 to 7.4)
IP-10	243 (199 to 294)	225 (178 to 334)
MCP-1	94 (75 to 121)	92.5 (80 to 125)
MCP-2	18 (14 to 22)	19 (16 to 28)
MCP-4	1310 (1110 to 1570)	1260 (1030 to 1520)
MIG	496 (328 to 705)	462.5 (303 to 701)
MIP-1 alpha	18 (18 to 23)	18 (18 to 19)
MIP-1 beta	164 (121 to 198)	153 (124 to 196)
MIP-3 alpha	20 (11 to 27)	19.5 (14 to 24)
MPIF-1	1500 (1300 to 1700)	1300 (1000 to 1500)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Cytokines and Chemokines in Step 1 of Study

Time frame:: Post-dose1 at Day 0 plus 1.5 Hours
Reported as:: Median · pg/mL

Concentrations of Cytokines and Chemokines in Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5500 (4000 to 8400)	5900 (4800 to 8100)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.8)	3.3 (3.3 to 3.9)
IL-18	168 (144 to 220)	168 (126 to 208)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 7.4)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	26000 (21000 to 32000)	25000 (19000 to 29000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.9 (3.6 to 5.5)	4.2 (3.3 to 5.1)
IP-10	224 (198 to 318)	226 (186 to 265)
MCP-1	74 (56 to 97)	75 (56 to 108)
MCP-2	18 (14 to 23)	20 (16 to 22)
MCP-4	1240 (943 to 1520)	1240 (951 to 1340)
MIG	423 (385 to 535)	378 (308 to 522)
MIP-1 alpha	18 (18 to 22)	18 (18 to 19)
MIP-1 beta	164 (132 to 194)	137 (114 to 167)
MIP-3 alpha	18 (15 to 26)	20 (14 to 24)
MPIF-1	1500 (1300 to 1800)	1200 (970 to 1400)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Cytokines and Chemokines During Step 1 of Study

Time frame:: Post-dose1 at Day 0 plus 6 Hours
Reported as:: Median · pg/mL

Concentrations of Cytokines and Chemokines During Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5400 (4100 to 7600)	5900 (4300 to 7600)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.3)	3.3 (3.3 to 3.3)
IL-18	170 (130 to 225)	169 (110 to 220)
IL-2	5.9 (5.9 to 6)	5.9 (5.9 to 6)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	3.4 (2.4 to 6)	1.6 (1.6 to 1.7)
IL-6r	26000 (20000 to 33000)	25000 (22000 to 30000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.6 (3.9 to 5.5)	4.6 (3.9 to 7.2)
IP-10	207 (179 to 270)	204 (180 to 282)
MCP-1	94 (75 to 123)	85 (66 to 112)
MCP-2	18 (15 to 20)	18.5 (16 to 23)
MCP-4	1130 (912 to 1390)	1130 (989 to 1310)
MIG	459 (332 to 567)	372.5 (302 to 557)
MIP-1 alpha	18 (18 to 21)	18 (18 to 19)
MIP-1 beta	165 (129 to 181)	141 (111 to 174)
MIP-3 alpha	19 (15 to 28)	18.5 (12 to 23)
MPIF-1	1400 (1200 to 1600)	1300 (1000 to 1500)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines and Chemokines Concentrations - Study Step 1

Time frame:: Post-dose1 at Day 0 plus 12 Hours
Reported as:: Median · pg/mL

Cytokines and Chemokines Concentrations - Study Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5900 (4400 to 8800)	6400 (5000 to 8000)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.9 (3.3 to 5.5)	3.3 (3.3 to 3.3)
IL-18	171 (155 to 235)	181.5 (128 to 205)
IL-2	5.9 (5.9 to 6.5)	5.9 (5.9 to 6)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	6.3 (3.9 to 8.2)	1.6 (1.6 to 1.6)
IL-6r	26000 (21000 to 32000)	24000 (22000 to 33000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.2 (3.5 to 5.1)	4.8 (4 to 5.6)
IP-10	236 (197 to 281)	194 (167 to 282)
MCP-1	111 (87 to 137)	111.5 (84 to 129)
MCP-2	19 (15 to 27)	19.5 (15 to 25)
MCP-4	1260 (1000 to 1530)	1265 (1030 to 1520)
MIG	478 (361 to 614)	410 (296 to 588)
MIP-1 alpha	18 (18 to 21)	18 (18 to 19)
MIP-1 beta	183 (142 to 212)	132 (102 to 171)
MIP-3 alpha	20 (17 to 28)	19.5 (14 to 27)
MPIF-1	1600 (1200 to 1700)	1300 (1000 to 1700)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines and Chemokines Concentrations in Step 1 of Study

Time frame:: Post-dose1 at Day 0 plus 18 Hours
Reported as:: Median · pg/mL

Cytokines and Chemokines Concentrations in Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5750 (3400 to 8000)	4700 (3500 to 5900)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.8 (1.6 to 2.4)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 4.8)	3.3 (3.3 to 3.3)
IL-18	180 (155 to 217)	126 (93 to 168)
IL-2	5.9 (5.9 to 6)	5.9 (5.9 to 6)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	4.5 (3.1 to 6.9)	1.6 (1.6 to 1.6)
IL-6r	22500 (17000 to 26000)	22000 (19000 to 31000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.9 (4.5 to 6.4)	5.1 (4.2 to 6)
IP-10	319 (268 to 477)	228 (184 to 258)
MCP-1	111 (91 to 130)	115 (98 to 130)
MCP-2	29.5 (19 to 34)	20 (17 to 22)
MCP-4	1400 (1310 to 1650)	1400 (1220 to 1560)
MIG	571 (443 to 684)	473 (367 to 722)
MIP-1 alpha	18 (18 to 20)	18 (18 to 18)
MIP-1 beta	258 (200 to 303)	134 (117 to 206)
MIP-3 alpha	35.5 (24 to 45)	20 (17 to 30)
MPIF-1	1850 (1500 to 2100)	1400 (1100 to 1600)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines and Chemokines Concentrations During Step 1 of Study

Time frame:: Post-dose1 at Day 1
Reported as:: Median · pg/mL

Cytokines and Chemokines Concentrations During Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5950 (4200 to 9500)	6000 (4900 to 8900)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	5.2 (3.6 to 6.8)	3.3 (3.3 to 3.6)
IL-18	198.5 (167 to 267)	181 (123 to 200)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	3 (1.6 to 4.1)	1.6 (1.6 to 1.6)
IL-6r	26500 (22000 to 35000)	24500 (21500 to 31000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.1 (4.1 to 6.3)	4.4 (3.8 to 5.6)
IP-10	295 (251 to 414)	219 (179 to 326)
MCP-1	85.5 (67 to 101)	92 (73 to 112)
MCP-2	21 (16 to 26)	20 (17 to 25)
MCP-4	1360 (1120 to 1600)	1270 (1100 to 1630)
MIG	526 (441 to 678)	425 (299 to 606)
MIP-1 alpha	18 (18 to 22)	18 (18 to 20)
MIP-1 beta	282.5 (234 to 408)	145 (130 to 207)
MIP-3 alpha	17 (14 to 28)	16 (12 to 23)
MPIF-1	2300 (2000 to 2600)	1400 (1200 to 1800)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines/Chemokines Concentrations - Study Step 1

Time frame:: Post-dose1 at Day 2
Reported as:: Median · pg/mL

Cytokines/Chemokines Concentrations - Study Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5800 (4300 to 9300)	6300 (5000 to 7400)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.6 (3.3 to 4.3)	3.3 (3.3 to 3.7)
IL-18	219 (165 to 252)	167 (130 to 219)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	25000 (18000 to 33000)	24000 (20000 to 30000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.8 (3.8 to 6.4)	5 (4.2 to 5.6)
IP-10	455 (291 to 569)	214 (174 to 303)
MCP-1	83 (55 to 95)	79 (58 to 101)
MCP-2	22 (17 to 25)	20 (15 to 25)
MCP-4	1300 (1010 to 1600)	1230 (1010 to 1390)
MIG	546 (435 to 593)	364 (255 to 620)
MIP-1 alpha	18 (18 to 22)	18 (18 to 21)
MIP-1 beta	200 (160 to 265)	149 (126 to 189)
MIP-3 alpha	19 (14 to 25)	21 (16 to 28)
MPIF-1	1600 (1300 to 2000)	1300 (890 to 1500)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines/Chemokines Concentrations in Step 1 of Study

Time frame:: Post-dose1 at Day 7
Reported as:: Median · pg/mL

Cytokines/Chemokines Concentrations in Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6600 (4100 to 8600)	6700 (4800 to 8500)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.6 (3.3 to 4.9)	3.3 (3.3 to 3.9)
IL-18	202 (168 to 265)	191 (126 to 231)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	27000 (21000 to 35000)	25000 (21000 to 31000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5 (4.2 to 6.9)	5.1 (4.2 to 6.7)
IP-10	235 (178 to 350)	220.5 (185 to 279)
MCP-1	94 (73 to 119)	88.5 (71 to 125)
MCP-2	20 (16 to 24)	22.5 (18 to 30)
MCP-4	1250 (1040 to 1390)	1240 (1010 to 1420)
MIG	475 (384 to 582)	436.5 (304 to 687)
MIP-1 alpha	18 (18 to 26)	18 (18 to 22)
MIP-1 beta	171 (142 to 243)	173.5 (146 to 213)
MIP-3 alpha	18 (14 to 26)	22 (16 to 34)
MPIF-1	1600 (1300 to 2100)	1300 (1100 to 1500)
TNF-alpha	13 (13 to 17)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines/Chemokines Concentrations During Step 1 of Study

Time frame:: Post-dose1 at Day 30
Reported as:: Median · pg/mL

Cytokines/Chemokines Concentrations During Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6200 (4300 to 9000)	6500 (5200 to 8000)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.4)	3.3 (3.3 to 3.4)
IL-18	202 (151 to 248)	183 (136 to 234)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 2.3)	1.6 (1.6 to 1.6)
IL-6r	27000 (20000 to 32000)	26000 (21000 to 30000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.8 (3.9 to 6)	4.3 (3.4 to 5.8)
IP-10	245 (211 to 349)	235 (183 to 264)
MCP-1	99 (72 to 136)	86 (72 to 111)
MCP-2	16 (14 to 23)	20 (14 to 24)
MCP-4	1180 (937 to 1340)	1010 (937 to 1210)
MIG	475 (393 to 768)	452 (281 to 691)
MIP-1 alpha	18 (18 to 21)	18 (18 to 18)
MIP-1 beta	175 (141 to 240)	147 (126 to 181)
MIP-3 alpha	20 (15 to 30)	20 (16 to 27)
MPIF-1	1500 (1300 to 1800)	1300 (940 to 1500)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines and Chemokines - Step 1

Time frame:: Post-dose 2 at Day 30 plus 1.5 Hours
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines and Chemokines - Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6300 (3900 to 7600)	5700 (4900 to 6800)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 4.5)	3.3 (3.3 to 4.3)
IL-18	171 (143 to 223)	176 (127 to 207)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	24000 (18000 to 30000)	25000 (20000 to 31000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	3.2 (3 to 5.6)	4.3 (2.7 to 5)
IP-10	223 (189 to 336)	215 (173 to 247)
MCP-1	85 (58 to 112)	87 (66 to 104)
MCP-2	15 (12 to 23)	18 (15 to 22)
MCP-4	1250 (1030 to 1400)	1090 (1020 to 1330)
MIG	421 (361 to 856)	367 (269 to 575)
MIP-1 alpha	18 (18 to 22)	18 (18 to 20)
MIP-1 beta	164 (132 to 196)	136 (115 to 170)
MIP-3 alpha	17 (10 to 22)	14 (11 to 19)
MPIF-1	1400 (1200 to 1500)	1200 (930 to 1500)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines and Chemokines - Study Step 1

Time frame:: Post-dose 2 at Day 30 plus 3 Hours
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines and Chemokines - Study Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6550 (4000 to 8200)	5700 (4450 to 6850)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 4.5)	3.3 (3.3 to 3.4)
IL-18	171.5 (146 to 204)	158 (104 to 206.5)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 2.5)	1.6 (1.6 to 1.6)
IL-6r	26000 (18000 to 31000)	23000 (19000 to 28500)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.7 (3.9 to 6)	4.5 (3.8 to 5)
IP-10	208 (182 to 275)	205.5 (176 to 243.5)
MCP-1	75 (62 to 95)	75 (51 to 85)
MCP-2	15.5 (12 to 27)	18 (14.5 to 22.5)
MCP-4	1095 (979 to 1410)	1085 (824.5 to 1250)
MIG	378.5 (313 to 513)	358 (237 to 650.5)
MIP-1 alpha	18 (18 to 20)	18 (18 to 18.5)
MIP-1 beta	153 (135 to 220)	138 (123.5 to 157.5)
MIP-3 alpha	15 (10 to 22)	14 (10 to 15.5)
MPIF-1	1500 (1200 to 1600)	1200 (980 to 1450)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines and Chemokines in Step 1 of Study

Time frame:: Post-dose 2 at Day 30 plus 6 hours
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6000 (4200 to 8100)	5850 (4550 to 7000)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.7)	3.3 (3.3 to 3.3)
IL-18	173.5 (151 to 227)	183 (127.5 to 211.5)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	4.4 (2.8 to 6.7)	1.6 (1.6 to 1.6)
IL-6r	23000 (18000 to 29000)	24500 (20500 to 30500)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.2 (3.5 to 6.7)	4.5 (3.5 to 5.2)
IP-10	210.5 (182 to 248)	196.5 (160 to 248.5)
MCP-1	116.5 (98 to 132)	95 (79 to 121)
MCP-2	17 (12 to 24)	18.5 (15 to 24)
MCP-4	1245 (954 to 1590)	1065 (936 to 1350)
MIG	375 (320 to 505)	387.5 (239 to 671)
MIP-1 alpha	18 (18 to 19)	18 (18 to 18)
MIP-1 beta	177.5 (128 to 225)	139.5 (127.5 to 163.5)
MIP-3 alpha	16 (10 to 24)	16 (12 to 22)
MPIF-1	1400 (1200 to 1600)	1300 (1015 to 1700)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines and Chemokines During Step 1 of Study

Time frame:: Post-dose 2 at Day 30 plus 9 Hours
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6200 (4100 to 7400)	5500 (4350 to 6850)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 5.2)	3.3 (3.3 to 3.4)
IL-18	177 (139 to 240)	165 (115 to 229.5)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 6.6)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	4.8 (3.2 to 6.7)	1.6 (1.6 to 1.6)
IL-6r	23000 (17000 to 30000)	24500 (18500 to 30500)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.1 (3.2 to 5.5)	4 (3.2 to 5.4)
IP-10	217 (180 to 326)	204 (168 to 234)
MCP-1	103 (88 to 119)	80 (55 to 106)
MCP-2	18 (14 to 24)	18.5 (14.5 to 20.5)
MCP-4	1190 (999 to 1470)	1075 (820 to 1295)
MIG	424 (384 to 621)	350 (300 to 620)
MIP-1 alpha	18 (18 to 19)	18 (18 to 18)
MIP-1 beta	167 (120 to 220)	123.5 (108.5 to 146.5)
MIP-3 alpha	16 (14 to 23)	15.5 (11 to 19)
MPIF-1	1400 (1100 to 1600)	1200 (950 to 1400)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines/Chemokines During Step 1 of Study

Time frame:: Post-dose 2 at Day 30 plus 12 Hours
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5800 (4000 to 7800)	5800 (4500 to 7000)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	2.3 (1.6 to 3.1)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.8)	3.3 (3.3 to 3.3)
IL-18	166 (146 to 212)	174 (124 to 220)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	6.4 (5 to 9)	1.6 (1.6 to 1.7)
IL-6r	23000 (21000 to 31000)	24000 (21000 to 32000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.9 (4.1 to 6)	5.2 (3.2 to 6)
IP-10	240 (228 to 335)	200 (166 to 240)
MCP-1	117 (96 to 150)	95 (71 to 121)
MCP-2	20 (14 to 26)	18 (15 to 22)
MCP-4	1100 (916 to 1330)	1040 (852 to 1170)
MIG	499 (398 to 872)	377 (290 to 689)
MIP-1 alpha	18 (18 to 20)	18 (18 to 18)
MIP-1 beta	191 (162 to 238)	134 (118 to 162)
MIP-3 alpha	20 (15 to 26)	14 (11 to 20)
MPIF-1	1500 (1100 to 1700)	1300 (1100 to 1500)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines/Chemokines - Step 1 of Study

Time frame:: Post-dose 2 at Day 30 plus 18 Hours
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	5400 (3400 to 8000)	4500 (2900 to 5800)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	5.2 (1.6 to 7.4)	1.6 (1.6 to 1.6)
IL-10	4.5 (3.3 to 6)	3.3 (3.3 to 3.4)
IL-18	164.5 (151 to 241)	168 (128 to 197)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	6.3 (4.2 to 8.3)	1.6 (1.6 to 1.6)
IL-6r	19500 (13000 to 24000)	24000 (17000 to 32000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	4.8 (4.1 to 5.4)	5 (3.5 to 5.9)
IP-10	589.5 (296 to 715)	216 (196 to 430)
MCP-1	104.5 (76 to 116)	96 (91 to 106)
MCP-2	33 (19 to 54)	22 (16 to 23)
MCP-4	1220 (1090 to 1290)	1260 (1000 to 1340)
MIG	565.5 (373 to 791)	442 (300 to 633)
MIP-1 alpha	18 (18 to 23)	18 (18 to 23)
MIP-1 beta	283.5 (228 to 327)	144 (111 to 176)
MIP-3 alpha	24 (19 to 31)	17 (11 to 20)
MPIF-1	1600 (1300 to 2300)	1400 (1100 to 1700)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines/Chemokines in Step 1 of Study

Time frame:: Post-dose 2 at Day 31
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6800 (4300 to 8200)	5800 (5200 to 7100)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	4.8 (1.7 to 8.6)	1.6 (1.6 to 1.6)
IL-10	4.8 (3.3 to 6.3)	3.3 (3.3 to 3.3)
IL-18	185 (151 to 258)	166 (137 to 217)
IL-2	8.5 (5.9 to 8.5)	5.9 (5.9 to 8.5)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	3.6 (1.7 to 7.2)	1.6 (1.6 to 1.6)
IL-6r	26000 (17000 to 33000)	24000 (22000 to 31000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.6 (4.8 to 7)	4.8 (3.9 to 5.9)
IP-10	763 (405 to 1130)	212 (197 to 270)
MCP-1	101 (79 to 137)	71 (60 to 93)
MCP-2	35 (19 to 67)	17 (14 to 19)
MCP-4	1250 (1090 to 1400)	1090 (912 to 1330)
MIG	763 (604 to 1260)	427 (308 to 597)
MIP-1 alpha	18 (18 to 21)	18 (18 to 18)
MIP-1 beta	383 (301 to 540)	142 (120 to 176)
MIP-3 alpha	22 (17 to 25)	19 (12 to 28)
MPIF-1	2000 (1500 to 2300)	1100 (950 to 1600)
TNF-alpha	15 (13 to 21)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Plasma Cytokines and Chemokines - Step 1

Time frame:: Post-dose 2 at Day 32
Reported as:: Median · pg/mL

Concentrations of Plasma Cytokines and Chemokines - Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	7000 (4400 to 9100)	6000 (4900 to 8000)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.5 (3.3 to 5.3)	3.3 (3.3 to 3.5)
IL-18	238 (195 to 269)	190 (135 to 238)
IL-2	5.9 (5.9 to 7)	5.9 (5.9 to 7)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 2.5)	1.6 (1.6 to 1.6)
IL-6r	27000 (21000 to 32000)	24000 (21000 to 31000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.5 (4.3 to 6.5)	5.1 (4 to 6.5)
IP-10	760 (492 to 993)	226 (192 to 276)
MCP-1	75 (55 to 94)	77 (65 to 121)
MCP-2	24 (17 to 31)	21 (17 to 25)
MCP-4	1350 (1080 to 1580)	1260 (1010 to 1560)
MIG	850 (667 to 1070)	410 (320 to 581)
MIP-1 alpha	18 (18 to 19)	18 (18 to 23)
MIP-1 beta	268 (222 to 307)	142 (124 to 171)
MIP-3 alpha	23 (16 to 30)	19 (13 to 28)
MPIF-1	1800 (1400 to 2300)	1200 (990 to 1700)
TNF-alpha	13 (13 to 14)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Plasma Cytokines and Chemokines in Step 1

Time frame:: Post-dose 2 at Day 33
Reported as:: Median · pg/mL

Concentrations of Plasma Cytokines and Chemokines in Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6400 (4400 to 8700)	6300 (5100 to 8000)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.6)	3.3 (3.3 to 3.6)
IL-18	256 (195 to 351)	181 (142 to 231)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	26000 (21000 to 33000)	25000 (21000 to 28000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.5 (4.3 to 7.4)	5.5 (4.3 to 6.2)
IP-10	366 (288 to 524)	249 (220 to 319)
MCP-1	85 (65 to 101)	93 (77 to 131)
MCP-2	20 (16 to 28)	20 (17 to 26)
MCP-4	1390 (1190 to 1600)	1280 (1090 to 1600)
MIG	796 (586 to 908)	537 (456 to 722)
MIP-1 alpha	22 (18 to 24)	19 (18 to 22)
MIP-1 beta	241 (175 to 279)	163 (135 to 201)
MIP-3 alpha	25 (21 to 40)	25 (21 to 32)
MPIF-1	1800 (1400 to 2200)	1300 (1100 to 1600)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3.4)

PrimaryConcentrations of Plasma Cytokines and Chemokines During Step 1

Time frame:: Post-dose 2 at Day 37
Reported as:: Median · pg/mL

Concentrations of Plasma Cytokines and Chemokines During Step 1
pg/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
E-selectin	6200 (4000 to 8200)	6000 (5000 to 7700)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.3)	3.3 (3.3 to 3.3)
IL-18	194 (156 to 256)	166 (123 to 196)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	28000 (16000 to 35000)	25000 (20000 to 27000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.3 (3.9 to 6.6)	5.5 (4.6 to 6)
IP-10	259 (213 to 296)	223 (179 to 289)
MCP-1	83 (66 to 109)	85 (63 to 99)
MCP-2	17 (13 to 23)	20 (16 to 24)
MCP-4	1220 (1110 to 1480)	1210 (1010 to 1340)
MIG	447 (398 to 535)	364 (284 to 472)
MIP-1 alpha	18 (18 to 23)	18 (18 to 19)
MIP-1 beta	150 (119 to 190)	151 (126 to 175)
MIP-3 alpha	18 (15 to 28)	18 (15 to 24)
MPIF-1	1600 (1200 to 1800)	1300 (1000 to 1400)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryConcentrations of Cytokines and Chemokines - Step 2

Time frame:: Pre-dose 1 at Day 0
Reported as:: Median · pg/mL

Concentrations of Cytokines and Chemokines - Step 2
pg/mL	HBsAg/AS_2 Group	Engerix-B_2 Group
E-selectin	8100 (4200 to 8900)	5400 (4400 to 5500)
GM-CSF	14 (14 to 14)	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.8)	3.3 (3.3 to 3.3)
IL-18	199.5 (175 to 377)	179 (152 to 182)
IL-2	5.9 (5.9 to 5.9)	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)	1.6 (1.6 to 1.6)
IL-6r	32000 (29000 to 36000)	30000 (28000 to 36000)
IL-7	8.2 (8.2 to 8.2)	8.2 (8.2 to 8.2)
IL-8	5.3 (3.5 to 11)	4.4 (3.5 to 6.2)
IP-10	300.5 (275 to 370)	234 (166 to 278)
MCP-1	86.5 (77 to 132)	87 (67 to 96)
MCP-2	22.5 (17 to 27)	27 (19 to 30)
MCP-4	1805 (1300 to 2010)	2120 (1720 to 2260)
MIP-1 alpha	18 (18 to 18)	18 (18 to 18)
MIP-1 beta	234 (186 to 255)	253 (200 to 300)
MIP-3 alpha	28.5 (23 to 64)	29 (17 to 42)
MPIF-1	1095 (820 to 1200)	1100 (930 to 1200)
TNF-alpha	13 (13 to 13)	13 (13 to 13)
TNF-beta	3 (3 to 3)	3 (3 to 3)

PrimaryCytokines and Chemokines Concentrations - Step 2

Time frame:: Post-dose 1 at Day 1
Reported as:: Median · pg/mL

Cytokines and Chemokines Concentrations - Step 2
pg/mL	HBsAg/AS_2 Group
E-selectin	7900 (4300 to 9100)
GM-CSF	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)
IL-10	3.8 (3.3 to 4.7)
IL-18	206 (182 to 260)
IL-2	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)
IL-6	1.7 (1.6 to 2.6)
IL-6r	24000 (22000 to 33000)
IL-7	8.2 (8.2 to 8.2)
IL-8	3.9 (2.6 to 7.1)
IP-10	294 (199 to 390)
MCP-1	35 (27 to 114)
MCP-2	26 (20 to 29)
MCP-4	1240 (1130 to 1640)
MIP-1 alpha	18 (18 to 32)
MIP-1 beta	318 (241 to 391)
MIP-3 alpha	32 (17 to 46)
MPIF-1	1400 (1200 to 1500)
TNF-alpha	13 (13 to 13)
TNF-beta	3 (3 to 3)

PrimaryConcentrations of Cytokines and Chemokines During Step 2

Time frame:: Post-dose 1 at Day 30
Reported as:: Median · pg/mL

Concentrations of Cytokines and Chemokines During Step 2
pg/mL	HBsAg/AS_2 Group
E-selectin	6200 (3600 to 8450)
GM-CSF	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.6)
IL-18	166.5 (132.5 to 271.5)
IL-2	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 11.2)
IL-5	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.7)
IL-6r	29000 (24500 to 33500)
IL-7	8.2 (8.2 to 10.1)
IL-8	4.3 (3.1 to 8.4)
IP-10	231.5 (160.5 to 318.5)
MCP-1	46 (35 to 115.5)
MCP-2	19.5 (17 to 20.5)
MCP-4	1340 (1115 to 1450)
MIP-1 alpha	18 (18 to 18)
MIP-1 beta	172 (158.5 to 196.5)
MIP-3 alpha	25 (15 to 30.5)
MPIF-1	1200 (855 to 1400)
TNF-alpha	13 (13 to 13)
TNF-beta	3 (3 to 3)

PrimaryConcentrations of Cytokines and Chemokines in Step 2

Time frame:: Post-dose2 at Day 30 plus 6 Hours
Reported as:: Median · pg/mL

Concentrations of Cytokines and Chemokines in Step 2
pg/mL	HBsAg/AS_2 Group
E-selectin	5400 (3400 to 8300)
GM-CSF	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.3)
IL-18	172 (150 to 247)
IL-2	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 10)
IL-5	2.7 (2.7 to 2.7)
IL-6	3.7 (1.6 to 4.7)
IL-6r	34000 (27000 to 43000)
IL-7	12 (8.2 to 21)
IL-8	6.1 (3.6 to 9.1)
IP-10	163 (128 to 205)
MCP-1	59 (27 to 86)
MCP-2	22 (18 to 25)
MCP-4	1330 (979 to 1540)
MIP-1 alpha	18 (18 to 18)
MIP-1 beta	182 (154 to 266)
MIP-3 alpha	21 (13 to 28)
MPIF-1	1300 (980 to 1700)
TNF-alpha	13 (13 to 13)
TNF-beta	3 (3 to 6.3)

PrimaryConcentrations of Cytokines/Chemokines - Step 2

Time frame:: Post-dose 2 at Day 31
Reported as:: Median · pg/mL

Concentrations of Cytokines/Chemokines - Step 2
pg/mL	HBsAg/AS_2 Group
E-selectin	7450 (4600 to 10500)
GM-CSF	14 (14 to 14)
IFN-γ	6.2 (3.4 to 17.6)
IL-10	3.3 (3.3 to 4.4)
IL-18	234 (181 to 339.5)
IL-2	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)
IL-4	9.7 (9.4 to 10)
IL-5	2.7 (2.7 to 2.7)
IL-6	4 (2.2 to 5.7)
IL-6r	30500 (27000 to 41500)
IL-7	10.1 (8.2 to 23.5)
IL-8	7.9 (7.3 to 10.9)
IP-10	737.5 (510 to 1270)
MCP-1	142.5 (104 to 153)
MCP-2	40.5 (32 to 72.5)
MCP-4	1330 (974 to 1780)
MIP-1 alpha	18 (18 to 18)
MIP-1 beta	580 (359.5 to 780.5)
MIP-3 alpha	28 (19 to 39.5)
MPIF-1	1750 (1500 to 1850)
TNF-alpha	13 (13 to 13)
TNF-beta	3 (3 to 3)

PrimaryConcentrations of Cytokines/Chemokines in Step 2

Time frame:: Post-dose 2 at Day 37
Reported as:: Median · pg/mL

Concentrations of Cytokines/Chemokines in Step 2
pg/mL	HBsAg/AS_2 Group
E-selectin	6550 (3250 to 8450)
GM-CSF	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.8)
IL-18	232 (145.5 to 322)
IL-2	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)
IL-4	9.7 (9.4 to 14)
IL-5	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.7)
IL-6r	28000 (26500 to 34500)
IL-7	8.2 (8.2 to 8.2)
IL-8	8.5 (6.7 to 9.7)
IP-10	170 (143 to 210)
MCP-1	72.5 (27 to 104)
MCP-2	18.5 (15 to 23)
MCP-4	1275 (881.5 to 1635)
MIP-1 alpha	18 (18 to 18)
MIP-1 beta	174 (152.5 to 187.5)
MIP-3 alpha	17 (11.5 to 94)
MPIF-1	1100 (995 to 1450)
TNF-alpha	13 (13 to 13)
TNF-beta	3 (3 to 11.2)

PrimaryConcentrations of Cytokines/Chemokines During Step 2

Time frame:: Post-dose 2 at Day 180
Reported as:: Median · pg/mL

Concentrations of Cytokines/Chemokines During Step 2
pg/mL	Engerix-B_2 Group
E-selectin	4900 (4300 to 5800)
GM-CSF	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.3)
IL-18	159 (144 to 190)
IL-2	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)
IL-6r	24000 (24000 to 32000)
IL-7	8.2 (8.2 to 8.2)
IL-8	4.4 (3.5 to 5.3)
IP-10	156 (121 to 260)
MCP-1	77 (57 to 77)
MCP-2	20 (14 to 27)
MCP-4	1640 (1540 to 1810)
MIP-1 alpha	18 (18 to 18)
MIP-1 beta	189 (177 to 257)
MIP-3 alpha	25 (13 to 32)
MPIF-1	920 (830 to 970)
TNF-alpha	13 (13 to 13)
TNF-beta	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines and Chemokines - Study Step 2

Time frame:: Post-dose 3 at Day 180 plus 6 Hours
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines and Chemokines - Study Step 2
pg/mL	Engerix-B_2 Group
E-selectin	4600 (4100 to 5800)
GM-CSF	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.3)
IL-18	144 (133 to 152)
IL-2	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)
IL-6r	25000 (24000 to 30000)
IL-7	8.2 (8.2 to 8.2)
IL-8	3.5 (2.6 to 4.4)
IP-10	145 (105 to 214)
MCP-1	46 (35 to 67)
MCP-2	22 (15 to 26)
MCP-4	1640 (1350 to 1720)
MIP-1 alpha	18 (18 to 18)
MIP-1 beta	193 (175 to 211)
MIP-3 alpha	21 (15 to 25)
MPIF-1	890 (840 to 1100)
TNF-alpha	13 (13 to 13)
TNF-beta	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines and Chemokines in Step 2 of Study

Time frame:: Post-dose 3 at Day 181
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
pg/mL	Engerix-B_2 Group
E-selectin	4900 (4300 to 5900)
GM-CSF	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.8)
IL-18	152 (140.5 to 192)
IL-2	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 11.2)
IL-5	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)
IL-6r	24500 (22500 to 31500)
IL-7	8.2 (8.2 to 8.2)
IL-8	3.5 (2.6 to 3.5)
IP-10	152 (119.5 to 211.5)
MCP-1	67 (35 to 86.5)
MCP-2	19.5 (13 to 25.5)
MCP-4	1720 (1390 to 1790)
MIP-1 alpha	18 (18 to 18)
MIP-1 beta	173.5 (166.5 to 213)
MIP-3 alpha	17 (15 to 21)
MPIF-1	875 (745 to 1100)
TNF-alpha	13 (13 to 13)
TNF-beta	3 (3 to 3)

PrimaryPlasma Concentrations of Cytokines and Chemokines During Step 2 of Study

Time frame:: Post-dose 3 at Day 187
Reported as:: Median · pg/mL

Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
pg/mL	Engerix-B_2 Group
E-selectin	4600 (4200 to 5500)
GM-CSF	14 (14 to 14)
IFN-γ	1.6 (1.6 to 1.6)
IL-10	3.3 (3.3 to 3.3)
IL-18	163 (137 to 167)
IL-2	5.9 (5.9 to 5.9)
IL-3	1.6 (1.6 to 1.6)
IL-4	9.4 (9.4 to 9.4)
IL-5	2.7 (2.7 to 2.7)
IL-6	1.6 (1.6 to 1.6)
IL-6r	30000 (26000 to 35000)
IL-7	8.2 (8.2 to 8.2)
IL-8	3.5 (3.5 to 4.4)
IP-10	201 (107 to 201)
MCP-1	35 (35 to 35)
MCP-2	22 (17 to 25)
MCP-4	1810 (1720 to 2120)
MIP-1 alpha	18 (18 to 18)
MIP-1 beta	175 (175 to 193)
MIP-3 alpha	17 (17 to 25)
MPIF-1	820 (750 to 970)
TNF-alpha	13 (13 to 13)
TNF-beta	3 (3 to 3)

SecondaryAnti-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
Reported as:: Geometric mean · mIU/mL

Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1
mIU/mL	HBsAg/AS_1 Group	Engerix-B_1 Group
Anti-HBs, PRE (D0)	3.1 (3.1 to 3.1)	3.1 (3.1 to 3.1)
Anti-HBs, PII (D60)	3322.4 (2332.2 to 4733.0)	35.8 (11.6 to 111.1)

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Participants	HBsAg/AS_1 Group	Engerix-B_1 Group
Any pain, PP	2	3
Grade 3 pain, PP	0	1
Any redness, PP	0	0
Grade 3 redness, PP	0	0
Any swelling, PP	0	0
Grade 3 swelling, PP	0	0
Any pain, D1	18	7
Grade 3 pain, D1	0	0
Any redness, D1	6	1
Grade 3 redness, D1	0	0
Any swelling, D1	4	0
Grade 3 swelling, D1	0	0
Any pain, D2	15	6
Grade 3 pain, D2	0	1
Any redness, D2	5	0
Grade 3 redness, D2	1	0
Any swelling, D2	1	0
Grade 3 swelling, D2	0	0
Any pain, Across Doses	21	8
Grade 3 pain, Across Doses	0	1
Any redness, Across Doses	8	1
Grade 3 redness, Across Doses	1	0
Any swelling, Across Doses	4	0
Grade 3 swelling, Across Doses	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Participants	HBsAg/AS_1 Group	Engerix-B_1 Group
Any fatigue, PP	8	12
Grade 3 fatigue, PP	0	1
Related fatigue, PP	2	2
Any gastrointestinal symptoms, PP	8	8
Grade 3 gastrointestinal symptoms, PP	0	2
Related gastrointestinal symptoms, PP	1	0
Any headache, PP	11	13
Grade 3 headache, PP	0	1
Related headache, PP	2	2
Any malaise, PP	3	4
Grade 3 malaise, PP	0	0
Related malaise, PP	0	1
Any myalgia, PP	2	5
Grade 3 myalgia, PP	0	1
Related myalgia, PP	1	0
Any shivering, PP	4	3
Grade 3 shivering, PP	0	1
Related shivering, PP	0	0
Any temperature, PP	1	2
Grade 3 temperature, PP	0	0
Related temperature, PP	0	0
Any Fatigue, D1	3	6
Grade 3 fatigue, D1	1	0
Related fatigue, D1	2	6
Any gastrointestinal symptoms, D1	4	6
Grade 3 gastrointestinal symptoms, D1	0	1
Related gastrointestinal symptoms, D1	4	3
Any headache, D1	14	5
Grade 3 headache, D1	0	1
Related headache, D1	11	4
Any malaise, D1	4	2
Grade 3 malaise, D1	0	0
Related malaise, D1	4	2
Any myalgia, D1	10	1
Grade 3 myalgia, D1	0	0
Related myalgia, D1	9	1
Any shivering, D1	2	0
Grade 3 shivering, D1	0	0
Related shivering, D1	2	0
Any temperature (≥37.5 °C), D1	2	1
Grade 3 temperature (> 39.5 °C), D1	0	0
Related temperature, D1	1	0
Any Fatigue, D2	10	8
Grade 3 fatigue, D2	1	0
Related fatigue, D2	10	7
Any gastrointestinal symptoms, D2	4	5
Grade 3 gastrointestinal symptoms, D2	0	3
Related gastrointestinal symptoms, D2	4	5
Any headache, D2	14	5
Grade 3 headache, D2	0	1
Related headache, D2	14	5
Any malaise, D2	7	6
Grade 3 malaise, D2	2	1
Related malaise, D2	7	6
Any myalgia, D2	10	2
Grade 3 myalgia, D2	0	0
Related myalgia, D2	10	1
Any shivering, D2	9	2
Grade 3 shivering, D2	0	0
Related shivering, D2	9	2
Any temperature (≥37.5 °C), D2	5	1
Grade 3 temperature (> 39.5 °C), D2	0	0
Related temperature, D2	4	0
Any Fatigue, Across Doses	10	9
Grade 3 fatigue, Across Doses	2	0
Related fatigue, Across Doses	10	9
Any gastrointestinal symptoms, Across Doses	8	8
Grade 3 gastrointestinal symptoms, Across Doses	0	4
Related gastrointestinal symptoms, Across Doses	8	7
Any headache, Across Doses	17	6
Grade 3 headache, Across Doses	0	1
Related headache, Across Doses	15	6
Any malaise, Across Doses	8	7
Grade 3 malaise, Across Doses	2	1
Related malaise, Across Doses	8	7
Any myalgia, Across Doses	14	2
Grade 3 myalgia, Across Doses	0	0
Related myalgia, Across Doses	13	2
Any shivering, Across Doses	10	2
Grade 3 shivering, Across Doses	0	0
Related shivering, Across Doses	10	2
Any temperature (≥37.5 °C), Across Doses	6	2
Grade 3 temperature (> 39.5 °C), Across Doses	0	0
Related temperature, Across Doses	4	0

SecondaryNumber 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.
Reported as:: Count of participants · Participants

Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Participants	HBsAg/AS_1 Group	Engerix-B_1 Group
Fever (≥37.5), placebo	0	0
Fever (≥37.5), D1	2	2
Fever (≥37.5), D2	8	0
Pain, placebo	1	4
Pain, D1	19	9
Pain, D2	19	8
Redness, placebo	0	0
Redness, D1	8	1
Redness, D2	7	0
Induration, placebo	0	0
Induration, D1	0	0
Induration, D2	1	0
Swelling, placebo	0	0
Swelling, D1	3	1
Swelling, D2	4	1
Muscle stiffness, placebo	0	2
Muscle stiffness, D1	14	5
Muscle stiffness, D2	15	4

SecondaryNumber 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.
Reported as:: Count of participants · Participants

Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1
Participants	HBsAg/AS_1 Group	Engerix-B_1 Group
Any AEs, post-placebo	12	16
Any AEs, post-product administration	14	15

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Serious Adverse Events (SAEs) - Step 1
Participants	HBsAg/AS_1 Group	Engerix-B_1 Group
Day 60 SAEs	0	0
Day 210 SAEs	0	1

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1
Participants	HBsAg/AS_1 Group	Engerix-B_1 Group
pIMDs - Day 60	0	0
pIMDs - Day 210	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1
Participants	HBsAg/AS_1 Group	Engerix-B_1 Group
MAEs - Day 60	0	0
MAEs - Day 210	0	1

SecondaryLevels 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
Reported as:: Median · U/L

Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
U/L	HBsAg/AS_1 Group	Engerix-B_1 Group
ALT, Dose 1, Day 0	27.5 (22.5 to 32.5)	27 (23 to 31)
ALT, Dose 1 (Day 0 H6)	26.5 (22 to 33)	26 (22 to 34)
ALT, Dose 1 (Day 0 H12)	27 (23.5 to 31.5)	26 (24 to 33)
ALT, Dose 1 (Day 0 H18)	28 (25 to 35)	24 (16 to 48)
ALT, Dose 1, Day 1	25.5 (20 to 33)	27 (20 to 35)
ALT, Dose 1, Day 7	26.5 (22 to 32.5)	28 (19 to 34)
ALT, Dose 2, Day 30	27 (22 to 36)	30 (24 to 33)
ALT, Dose 2 (Day 30 H6)	27 (23 to 34)	28 (25 to 32)
ALT, Dose 2 (Day 30 H12)	27 (24 to 34)	28 (23 to 33.5)
ALT, Dose 2 (Day 30 H18)	32 (25 to 37)	26 (24 to 46)
ALT, Dose 2, Day 31	27 (22 to 33)	27 (23 to 34)
ALT, Dose 2, Day 37	27 (22 to 30)	26 (23.5 to 33)
ALT, Dose 2, Day 60	28 (23 to 32)	28 (22.5 to 36)

SecondaryLevels 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
Reported as:: Median · U/L

Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
U/L	HBsAg/AS_1 Group	Engerix-B_1 Group
AST, Dose 1, Day 0	21 (18 to 26)	23 (18 to 25)
AST, Dose 1 (Day 0 H6)	20.5 (18.5 to 24)	21 (17 to 25)
AST, Dose 1 (Day 0 H12)	20 (18.5 to 22.5)	20 (17 to 25)
AST, Dose 1 (Day 0 H18)	19 (15 to 24)	18 (17 to 28)
AST, Dose 1, Day 1	19 (16 to 22.5)	20 (18 to 23)
AST, Dose 1, Day 7	21 (18.5 to 25.5)	21 (18 to 29)
AST, Dose 2, Day 30	21 (19 to 26)	23 (19 to 25)
AST, Dose 2 (Day 30 H6)	21 (19 to 24)	22 (20 to 25.5)
AST, Dose 2 (Day 30 H12)	20 (18 to 25)	21 (20 to 24.5)
AST, Dose 2 (Day 30 H18)	20 (19 to 22)	19.5 (16 to 30)
AST, Dose 2, Day 31	19 (17 to 23)	21 (18 to 25.5)
AST, Dose 2, Day 37	22 (19 to 25)	23 (18 to 29.5)
AST, Dose 2, Day 60	21 (18 to 26)	21.5 (18 to 28.5)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Basophils in Blood Samples - Step 1
billion cells/L	HBsAg/AS_1 Group	Engerix-B_1 Group
Basophils, Dose 1, Day 0	0.03 (0.02 to 0.04)	0.02 (0.02 to 0.03)
Basophils, Dose 1 (Day 0 H6)	0.03 (0.02 to 0.04)	0.03 (0.02 to 0.03)
Basophils, Dose 1 (Day 0 H12)	0.03 (0.02 to 0.05)	0.02 (0.02 to 0.03)
Basophils, Dose 1 (Day 0 H18)	0.03 (0.01 to 0.03)	0.02 (0.01 to 0.03)
Basophils, Dose 1, Day 1	0.03 (0.01 to 0.04)	0.02 (0.02 to 0.03)
Basophils, Dose 1, Day 7	0.03 (0.02 to 0.04)	0.03 (0.02 to 0.04)
Basophils, Dose 2, Day 30	0.03 (0.02 to 0.04)	0.02 (0.02 to 0.04)
Basophils, Dose 2 (Day 30 H6)	0.03 (0.02 to 0.04)	0.02 (0.02 to 0.03)
Basophils, Dose 2 (Day 30 H12)	0.02 (0.01 to 0.03)	0.02 (0.02 to 0.04)
Basophils, Dose 2 (Day 30 H18)	0.03 (0.01 to 0.03)	0.02 (0.01 to 0.03)
Basophils, Dose 2, Day 31	0.02 (0.01 to 0.03)	0.03 (0.02 to 0.04)
Basophils, Dose 2, Day 37	0.03 (0.02 to 0.06)	0.03 (0.02 to 0.03)
Basophils, Dose 2, Day 60	0.03 (0.02 to 0.04)	0.03 (0.02 to 0.03)

SecondaryLevels 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
Reported as:: Median · mg/dL

Levels of Total Bilirubin in Blood Samples - Step 1
mg/dL	HBsAg/AS_1 Group	Engerix-B_1 Group
Total bilirubin, Dose 1, Day 0	0.5 (0.4 to 0.7)	0.5 (0.3 to 0.7)
Total bilirubin, Dose 1 (Day 0 H6)	0.4 (0.25 to 0.5)	0.4 (0.3 to 0.5)
Total bilirubin, Dose 1 (Day 0 H12)	0.4 (0.3 to 0.6)	0.3 (0.3 to 0.5)
Total bilirubin, Dose 1 (Day 0 H18)	0.6 (0.4 to 0.8)	0.5 (0.3 to 0.6)
Total bilirubin, Dose 1, Day 1	0.7 (0.6 to 0.9)	0.5 (0.3 to 0.8)
Total bilirubin, Dose 1, Day 7	0.5 (0.4 to 0.7)	0.5 (0.3 to 0.6)
Total bilirubin, Dose 2, Day 30	0.6 (0.4 to 0.7)	0.5 (0.4 to 0.7)
Total bilirubin, Dose 2 (Day 30 H6)	0.4 (0.3 to 0.5)	0.4 (0.3 to 0.5)
Total bilirubin, Dose 2 (Day 30 H12)	0.5 (0.4 to 0.6)	0.4 (0.3 to 0.5)
Total bilirubin, Dose 2 (Day 30 H18)	0.6 (0.4 to 0.7)	0.45 (0.3 to 0.5)
Total bilirubin, Dose 2, Day 31	0.7 (0.5 to 1)	0.5 (0.45 to 0.7)
Total bilirubin, Dose 2, Day 37	0.5 (0.3 to 0.8)	0.5 (0.4 to 0.65)
Total bilirubin, Dose 2, Day 60	0.5 (0.4 to 0.6)	0.5 (0.4 to 0.6)

SecondaryLevels 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
Reported as:: Median · mg/dL

Levels of Serum Creatinine in Blood Samples - Step 1
mg/dL	HBsAg/AS_1 Group	Engerix-B_1 Group
Creatinine, Dose 1, Day 0	0.8 (0.75 to 0.93)	0.79 (0.72 to 0.85)
Creatinine, Dose 1 (Day 0 H6)	0.75 (0.66 to 0.85)	0.72 (0.69 to 0.82)
Creatinine, Dose 1 (Day 0 H12)	0.78 (0.66 to 0.83)	0.73 (0.68 to 0.83)
Creatinine, Dose 1 (Day 0 H18)	0.7 (0.61 to 0.77)	0.71 (0.63 to 0.84)
Creatinine, Dose 1, Day 1	0.74 (0.68 to 0.91)	0.77 (0.71 to 0.85)
Creatinine, Dose 1, Day 7	0.81 (0.71 to 0.93)	0.76 (0.69 to 0.87)
Creatinine, Dose 2, Day 30	0.82 (0.74 to 0.96)	0.79 (0.72 to 0.83)
Creatinine, Dose 2 (Day 30 H6)	0.75 (0.68 to 0.85)	0.73 (0.67 to 0.83)
Creatinine, Dose 2 (Day 30 H12)	0.76 (0.68 to 0.85)	0.72 (0.69 to 0.82)
Creatinine, Dose 2 (Day 30 H18)	0.74 (0.68 to 0.81)	0.73 (0.65 to 0.82)
Creatinine, Dose 2, Day 31	0.79 (0.69 to 0.93)	0.76 (0.7 to 0.87)
Creatinine, Dose 2, Day 37	0.81 (0.73 to 0.93)	0.73 (0.7 to 0.9)
Creatinine, Dose 2, Day 60	0.84 (0.69 to 0.97)	0.78 (0.72 to 0.91)

SecondaryLevels 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
Reported as:: Median · mg/dL

Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
mg/dL	HBsAg/AS_1 Group	Engerix-B_1 Group
CPK, Dose 1, Day 0	75 (56.5 to 108)	80 (62 to 148)
CPK, Dose 1 (Day 0 H6	69.5 (53 to 106)	75 (60 to 120)
CPK, Dose 1 (Day 0 H12)	64.5 (51 to 94.5)	77 (57 to 110)
CPK, Dose 1 (Day 0 H18)	59 (49 to 90)	61 (44 to 103)
CPK, Dose 1, Day 1	54 (42.5 to 79.5)	69 (46 to 96)
CPK, Dose 1, Day 7	66 (55.5 to 95)	80 (57 to 117)
CPK, Dose 2, Day 30	83 (48 to 122)	87 (55 to 145)
CPK, Dose 2 (Day 30 H6)	81 (45 to 108)	86 (53.5 to 140.5)
CPK, Dose 2 (Day 30 H12)	72 (50 to 98)	80.5 (54 to 134)
CPK, Dose 2 (Day 30 H18)	68.5 (53 to 103)	70 (37 to 120)
CPK, Dose 2, Day 31	67 (44 to 87)	75 (50 to 119)
CPK, Dose 2, Day 37	83 (59 to 119)	93.5 (54 to 115.5)
CPK, Dose 2, Day 60	82 (55 to 118)	82.5 (62 to 122)

SecondaryLevels 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
Reported as:: Median · mg/L

Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
mg/L	HBsAg/AS_1 Group	Engerix-B_1 Group
CRP, Dose 1, Day 0	1.15 (0.5 to 3)	1.7 (0.5 to 2.5)
CRP, Dose 1 (Day 0 H6)	0.8 (0.5 to 2.9)	1.6 (0.5 to 2.4)
CRP, Dose 1 (Day 0 H12)	1.5 (0.5 to 3.35)	1.4 (0.5 to 2.1)
CRP, Dose 1 (Day 0 H18)	2.9 (1.5 to 4.4)	1.25 (0.5 to 1.8)
CRP, Dose 1, Day 1	5.8 (3.1 to 11.1)	1.2 (0.5 to 1.8)
CRP, Dose 1, Day 7	1.9 (0.5 to 4.25)	1.3 (0.5 to 2.6)
CRP, Dose 2, Day 30	1.3 (0.5 to 4.3)	1.4 (0.5 to 3.1)
CRP, Dose 2 (Day 30 H6)	1.2 (0.5 to 2.3)	1.5 (0.5 to 3.05)
CRP, Dose 2 (Day 30 H12)	1.8 (0.5 to 2.8)	1.55 (0.5 to 3.1)
CRP, Dose 2 (Day 30 H18)	3.15 (2.1 to 5.3)	0.75 (0.5 to 2.8)
CRP, Dose 2, Day 31	5.8 (2.6 to 14.5)	1.2 (0.5 to 2.65)
CRP, Dose 2, Day 37	2.1 (1.1 to 5.8)	1.3 (0.5 to 2.95)
CRP, Dose 2, Day 60	1.4 (0.5 to 3.9)	1.05 (0.5 to 3.85)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Eosinophils in Blood Samples - Step 1
billion cells/L	HBsAg/AS_1 Group	Engerix-B_1 Group
Eosinophils, Dose 1, Day 0	0.2 (0.11 to 0.25)	0.13 (0.1 to 0.21)
Eosinophils, Dose 1 (Day 0 H6)	0.19 (0.13 to 0.27)	0.13 (0.09 to 0.21)
Eosinophils, Dose 1 (Day 0 H12)	0.21 (0.15 to 0.27)	0.17 (0.12 to 0.21)
Eosinophils, Dose 1 (Day 0 H18)	0.16 (0.12 to 0.3)	0.2 (0.16 to 0.31)
Eosinophils, Dose 1, Day 1	0.15 (0.08 to 0.25)	0.1 (0.07 to 0.2)
Eosinophils, Dose 1, Day 7	0.14 (0.08 to 0.2)	0.11 (0.09 to 0.17)
Eosinophils, Dose 2, Day 30	0.18 (0.11 to 0.25)	0.14 (0.09 to 0.26)
Eosinophils, Dose 2 (Day 30 H6)	0.18 (0.1 to 0.29)	0.13 (0.09 to 0.22)
Eosinophils, Dose 2 (Day 30 H12)	0.19 (0.12 to 0.31)	0.14 (0.09 to 0.24)
Eosinophils, Dose 2 (Day 30 H18)	0.14 (0.05 to 0.21)	0.19 (0.12 to 0.32)
Eosinophils, Dose 2, Day 31	0.14 (0.05 to 0.2)	0.13 (0.09 to 0.22)
Eosinophils, Dose 2, Day 37	0.19 (0.11 to 0.24)	0.15 (0.09 to 0.23)
Eosinophils, Dose 2, Day 60	0.19 (0.1 to 0.28)	0.14 (0.11 to 0.24)

SecondaryLevels 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
Reported as:: Median · g/dL

Levels of Haemoglobin in Blood Samples - Step 1
g/dL	HBsAg/AS_1 Group	Engerix-B_1 Group
Haemoglobin, Dose 1, Day 0	13.35 (12.7 to 14.5)	13.8 (12.5 to 14.8)
Haemoglobin, Dose 1 (Day 0 H6)	13.45 (12.3 to 14.05)	13.6 (12.5 to 14.6)
Haemoglobin, Dose 1 (Day 0 H12)	13.25 (12.3 to 14.3)	13.2 (12.6 to 14.5)
Haemoglobin, Dose 1 (Day 0 H18)	12.6 (12 to 13.9)	13.15 (12.5 to 14.5)
Haemoglobin, Dose 1, Day 1	13.5 (12.6 to 14.45)	13.8 (12.9 to 14.7)
Haemoglobin, Dose 1, Day 7	13.35 (12.55 to 14.35)	13.8 (12.8 to 14.6)
Haemoglobin, Dose 2, Day 30	13.7 (12.7 to 14.3)	13.4 (12.6 to 14.3)
Haemoglobin, Dose 2 (Day 30 H6)	13.4 (12.5 to 14)	13.55 (12.45 to 14.15)
Haemoglobin, Dose 2 (Day 30 H12)	13.2 (12.6 to 14.1)	13.1 (12.4 to 14.15)
Haemoglobin, Dose 2 (Day 30 H18)	13.15 (11.7 to 13.9)	13.05 (12.3 to 14.1)
Haemoglobin, Dose 2, Day 31	13.5 (12.5 to 14.4)	13.75 (12.65 to 14.6)
Haemoglobin, Dose 2, Day 37	13.6 (12.6 to 14.5)	13.65 (12.35 to 14.5)
Haemoglobin, Dose 2, Day 60	13.5 (12.4 to 14.5)	13.8 (12.2 to 14.5)

SecondaryLevels 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
Reported as:: Median · U/L

Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
U/L	HBsAg/AS_1 Group	Engerix-B_1 Group
LDH, Dose 1, Day 0	401.5 (377 to 473.5)	382 (346 to 438)
LDH, Dose 1 (Day 0 H6)	414 (388.5 to 449.5)	389 (353 to 423)
LDH, Dose 1 (Day 0 H12)	412 (392 to 457.5)	378 (339 to 426)
LDH, Dose 1 (Day 0 H18)	422 (341 to 461)	369.5 (302 to 410)
LDH, Dose 1, Day 1	389 (352 to 466)	367 (342 to 411)
LDH, Dose 1, Day 7	417.5 (382.5 to 479.5)	392 (371 to 436)
LDH, Dose 2, Day 30	391 (360 to 456)	395 (348 to 426)
LDH, Dose 2 (Day 30 H6)	437 (397 to 470)	396.5 (350.5 to 428)
LDH, Dose 2 (Day 30 H12)	425 (403 to 470)	382.5 (338.5 to 424)
LDH, Dose 2 (Day 30 H18)	403 (365 to 450)	334.5 (297 to 390)
LDH, Dose 2, Day 31	408 (373 to 453)	372 (354 to 403)
LDH, Dose 2, Day 37	442 (412 to 464)	403 (368.5 to 446)
LDH, Dose 2, Day 60	422 (397 to 478)	404 (374 to 431.5)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Lymphocytes in Blood Samples - Step 1
billion cells/L	HBsAg/AS_1 Group	Engerix-B_1 Group
Lymphocytes, Dose 1, Day 0	1.84 (1.45 to 1.98)	1.99 (1.61 to 2.26)
Lymphocytes, Dose 1 (Day 0 H6)	1.89 (1.48 to 2.35)	2.07 (1.52 to 2.46)
Lymphocytes, Dose 1 (Day 0 H12)	1.97 (1.72 to 2.33)	2.39 (2 to 2.97)
Lymphocytes, Dose 1 (Day 0 H18)	1.73 (1.41 to 2.48)	3.08 (2.45 to 3.53)
Lymphocytes, Dose 1, Day 1	1.58 (1.25 to 1.83)	1.94 (1.66 to 2.26)
Lymphocytes, Dose 1, Day 7	1.69 (1.37 to 1.91)	1.97 (1.56 to 2.17)
Lymphocytes, Dose 2, Day 30	1.67 (1.36 to 2.03)	1.97 (1.64 to 2.5)
Lymphocytes, Dose 2 (Day 30 H6)	1.81 (1.56 to 2.16)	2.11 (1.78 to 2.59)
Lymphocytes, Dose 2 (Day 30 H12)	1.9 (1.36 to 2.39)	2.35 (2.1 to 2.82)
Lymphocytes, Dose 2 (Day 30 H18)	1.46 (1.06 to 1.83)	2.99 (2.45 to 3.53)
Lymphocytes, Dose 2, Day 31	1.19 (0.89 to 1.43)	2.01 (1.75 to 2.5)
Lymphocytes, Dose 2, Day 37	1.74 (1.41 to 2.21)	2.01 (1.64 to 2.36)
Lymphocytes, Dose 2, Day 60	1.76 (1.4 to 2.29)	2.09 (1.73 to 2.31)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Monocytes in Blood Samples - Step 1
billion cells/L	HBsAg/AS_1 Group	Engerix-B_1 Group
Monocytes, Dose 1, Day 0	0.55 (0.45 to 0.66)	0.55 (0.4 to 0.62)
Monocytes, Dose 1 (Day 0 H6)	0.67 (0.59 to 0.76)	0.52 (0.4 to 0.55)
Monocytes, Dose 1 (Day 0 H12)	0.79 (0.62 to 0.9)	0.53 (0.41 to 0.6)
Monocytes, Dose 1 (Day 0 H18)	0.79 (0.66 to 0.92)	0.59 (0.5 to 0.61)
Monocytes, Dose 1, Day 1	0.72 (0.6 to 0.84)	0.45 (0.4 to 0.54)
Monocytes, Dose 1, Day 7	0.54 (0.43 to 0.63)	0.44 (0.37 to 0.58)
Monocytes, Dose 2, Day 30	0.55 (0.47 to 0.65)	0.5 (0.43 to 0.63)
Monocytes, Dose 2 (Day 30 H6)	0.67 (0.54 to 0.78)	0.48 (0.4 to 0.56)
Monocytes, Dose 2 (Day 30 H12)	0.66 (0.57 to 0.87)	0.51 (0.39 to 0.61)
Monocytes, Dose 2 (Day 30 H18)	0.8 (0.62 to 0.94)	0.49 (0.43 to 0.59)
Monocytes, Dose 2, Day 31	0.67 (0.53 to 0.81)	0.51 (0.44 to 0.67)
Monocytes, Dose 2, Day 37	0.51 (0.39 to 0.64)	0.51 (0.44 to 0.59)
Monocytes, Dose 2, Day 60	0.51 (0.39 to 0.68)	0.52 (0.44 to 0.64)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Neutrophils in Blood Samples - Step 1
billion cells/L	HBsAg/AS_1 Group	Engerix-B_1 Group
Neutrophils, Dose 1, Day 0	3.7 (3 to 5.49)	3.36 (2.77 to 4.21)
Neutrophils, Dose 1 (Day 0 H6)	6.48 (5.02 to 7.84)	4.12 (2.96 to 4.41)
Neutrophils, Dose 1 (Day 0 H12)	7.61 (6.87 to 9.01)	3.39 (3 to 4.53)
Neutrophils, Dose 1 (Day 0 H18)	6.07 (5.56 to 8.31)	3.61 (3.31 to 4.12)
Neutrophils, Dose 1, Day 1	6.13 (4.26 to 6.76)	3.76 (3.12 to 4.23)
Neutrophils, Dose 1, Day 7	4.17 (3.05 to 5.17)	3.46 (2.73 to 4.19)
Neutrophils, Dose 2, Day 30	3.66 (3.08 to 4.49)	2.91 (2.43 to 3.91)
Neutrophils, Dose 2 (Day 30 H6)	5.9 (5.28 to 7.75)	3.39 (2.93 to 4.07)
Neutrophils, Dose 2 (Day 30 H12)	7.07 (6.47 to 8.58)	3.36 (2.59 to 4.12)
Neutrophils, Dose 2 (Day 30 H18)	7.42 (6.84 to 9.35)	3.02 (2.39 to 3.74)
Neutrophils, Dose 2, Day 31	6.32 (4.78 to 7.41)	3.2 (2.77 to 4.9)
Neutrophils, Dose 2, Day 37	3.64 (2.73 to 5.48)	3.13 (2.68 to 4.47)
Neutrophils, Dose 2, Day 60	3.96 (3.16 to 4.96)	2.95 (2.5 to 3.71)

SecondaryPlatelet 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
Reported as:: Median · billion cells/L

Platelet Count in Blood Samples - Step 1
billion cells/L	HBsAg/AS_1 Group	Engerix-B_1 Group
Platelets, Dose 1, Day 0	228 (191.5 to 261.5)	225 (207 to 266)
Platelets, Dose 1 (Day 0 H6)	229 (204 to 259.5)	231 (212 to 263)
Platelets, Dose 1 (Day 0 H12)	235 (193 to 259)	230 (217 to 263)
Platelets, Dose 1 (Day 0 H18)	222 (186 to 260)	233 (215 to 274)
Platelets, Dose 1, Day 1	220.5 (187.5 to 258)	227 (206 to 269)
Platelets, Dose 1, Day 7	263.5 (215.5 to 291)	247 (217 to 268)
Platelets, Dose 2, Day 30	224 (185 to 267)	228 (204 to 260)
Platelets, Dose 2 (Day 30 H6)	238 (195 to 270)	232 (212 to 261.5)
Platelets, Dose 2 (Day 30 H12)	226 (194 to 260)	234 (213.5 to 258)
Platelets, Dose 2 (Day 30 H18)	230.5 (179 to 276)	229 (199 to 275)
Platelets, Dose 2, Day 31	218 (170 to 238)	217.5 (204.5 to 256.5)
Platelets, Dose 2, Day 37	253 (205 to 301)	243 (208.5 to 282)
Platelets, Dose 2, Day 60	240 (195 to 283)	241.5 (208 to 276.5)

SecondaryLevels 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
Reported as:: Median · trillion cells/L

Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
trillion cells/L	HBsAg/AS_1 Group	Engerix-B_1 Group
RBC, Dose 1, Day 0	4.51 (4.33 to 4.83)	4.56 (4.27 to 4.96)
RBC, Dose 1 (Day 0 H6)	4.45 (4.18 to 4.82)	4.58 (4.24 to 4.78)
RBC, Dose 1 (Day 0 H12)	4.42 (4.12 to 4.68)	4.51 (4.27 to 4.78)
RBC, Dose 1 (Day 0 H18)	4.19 (4.02 to 4.79)	4.36 (4.19 to 4.72)
RBC, Dose 1, Day 1	4.48 (4.25 to 4.85)	4.62 (4.36 to 4.78)
RBC, Dose 1, Day 7	4.54 (4.24 to 4.75)	4.54 (4.38 to 4.92)
RBC, Dose 2, Day 30	4.48 (4.27 to 4.7)	4.53 (4.25 to 4.79)
RBC, Dose 2 (Day 30 H6)	4.43 (4.14 to 4.6)	4.49 (4.26 to 4.8)
RBC, Dose 2 (Day 30 H12)	4.33 (4.21 to 4.62)	4.46 (4.25 to 4.71)
RBC, Dose 2 (Day 30 H18)	4.22 (3.86 to 4.66)	4.34 (4.09 to 4.62)
RBC, Dose 2, Day 31	4.42 (4.12 to 4.85)	4.58 (4.38 to 4.9)
RBC, Dose 2, Day 37	4.5 (4.13 to 4.84)	4.52 (4.2 to 4.88)
RBC, Dose 2, Day 60	4.5 (4.14 to 4.94)	4.61 (4.41 to 4.85)

SecondaryLevels 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
Reported as:: Median · mg/dL

Levels of Urea in Blood Samples - Step 1
mg/dL	HBsAg/AS_1 Group	Engerix-B_1 Group
Urea Nitrogen, Dose 1, Day 0	27.5 (23 to 35.5)	30 (26 to 35)
Urea Nitrogen, Dose 1 (Day 0 H6)	27 (24 to 31.5)	30 (26 to 34)
Urea Nitrogen, Dose 1 (Day 0 H12)	27 (24 to 31.5)	29 (27 to 32)
Urea Nitrogen, Dose 1 (Day 0 H18)	23 (21 to 32)	27 (24 to 30)
Urea Nitrogen, Dose 1, Day 1	23.5 (18.5 to 29)	25 (23 to 30)
Urea Nitrogen, Dose 1, Day 7	27.5 (24.5 to 35)	27 (23 to 31)
Urea Nitrogen, Dose 2, Day 30	28 (25 to 37)	26 (22 to 33)
Urea Nitrogen, Dose 2 (Day 30 H6)	29 (24 to 34)	26 (23 to 32.5)
Urea Nitrogen, Dose 2 (Day 30 H12)	28 (24 to 34)	27 (23.5 to 32)
Urea Nitrogen, Dose 2 (Day 30 H18)	25.5 (21 to 31)	24.5 (22 to 28)
Urea Nitrogen, Dose 2, Day 31	23 (19 to 30)	26 (21 to 28.5)
Urea Nitrogen, Dose 2, Day 37	26 (22 to 36)	25.5 (23 to 31)
Urea Nitrogen, Dose 2, Day 60	29 (22 to 33)	27 (23.5 to 30)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of White Blood Cells (WBC) - Step 1
billion cells/L	HBsAg/AS_1 Group	Engerix-B_1 Group
WBC, Dose 1, Day 0	6.25 (5.53 to 8.49)	6.33 (5.46 to 7.03)
WBC, Dose 1 (Day 0 H6)	9.73 (7.7 to 11.3)	6.49 (5.78 to 7.37)
WBC, Dose 1 (Day 0 H12)	10.45 (9.75 to 12.4)	6.84 (6 to 7.4)
WBC, Dose 1 (Day 0 H18)	8.72 (7.63 to 12.2)	7.43 (7.15 to 8.02)
WBC, Dose 1, Day 1	8.7 (6.37 to 9.7)	6.25 (5.85 to 6.83)
WBC, Dose 1, Day 7	6.67 (5.49 to 8.17)	6.14 (5.27 to 7.32)
WBC, Dose 2, Day 30	6.04 (5.48 to 8.07)	5.77 (4.96 to 7.21)
WBC, Dose 2 (Day 30 H6)	9.28 (7.91 to 10.4)	6.07 (5.76 to 6.96)
WBC, Dose 2 (Day 30 H12)	9.88 (9.29 to 11.4)	6.28 (5.8 to 7.37)
WBC, Dose 2 (Day 30 H18)	9.57 (8.24 to 12.2)	6.8 (6.49 to 7.21)
WBC, Dose 2, Day 31	8.21 (6.78 to 9.36)	6.34 (5.67 to 7.16)
WBC, Dose 2, Day 37	5.7 (5.13 to 8.46)	6.25 (5.46 to 7.31)
WBC, Dose 2, Day 60	6.48 (5.45 to 8.24)	6.07 (5.04 to 6.7)

SecondaryLevels 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
Reported as:: Median · mmHg

Levels of Diastolic Blood Pressure - Step 1
mmHg	HBsAg/AS_1 Group	Engerix-B_1 Group
Diastolic, placebo (D-30)	81 (74 to 86)	76.5 (67 to 83)
Diastolic, placebo (D-30 H1.5)	75 (69 to 83)	72 (65 to 79)
Diastolic, placebo (D-30 H3)	75.5 (68 to 83)	71.5 (65 to 80)
Diastolic, placebo (D-30 H6)	73.5 (67 to 83)	71.5 (67 to 82)
Diastolic, placebo (D-30 H9)	76 (71 to 86)	75 (67 to 84)
Diastolic, placebo (D-30 H12)	78 (69 to 84)	72.5 (66 to 80)
Diastolic, placebo (D-30 H18)	75 (67 to 80)	68 (64 to 84)
Diastolic, placebo (D-29)	77 (70 to 83)	73.5 (64 to 81)
Diastolic, placebo (D-28)	75 (70 to 83)	74.5 (69 to 78)
Diastolic, placebo (D-27)	78 (72 to 82)	75 (71 to 81)
Diastolic, placebo (D-23)	76 (71 to 81)	75.5 (66 to 80)
Diastolic, Dose 1 (D0)	76 (70.5 to 83)	76 (68 to 85)
Diastolic, Dose 1 (D0 H1.5)	74 (70 to 81)	73 (67 to 78)
Diastolic, Dose 1 (D0 H6)	73.5 (67.5 to 80)	72 (65 to 78)
Diastolic, Dose 1 (D0 H12)	72 (69 to 79.5)	72 (66 to 79)
Diastolic, Dose 1 (D0 H18)	73 (61 to 78)	66.5 (60 to 78)
Diastolic, Dose 1 (D1)	72 (69 to 79)	76 (66 to 80)
Diastolic, Dose 1 (D2)	74 (70 to 81.5)	73 (67 to 79)
Diastolic, Dose 1 (D7)	75 (71 to 79.5)	73 (70 to 82)
Diastolic, Dose 2 (D30)	76 (69 to 80)	77.5 (68.5 to 83)
Diastolic, Dose 2 (D30 H1.5)	72 (67 to 78)	70 (66 to 76.5)
Diastolic, Dose 2 (D30 H3)	72 (68 to 79)	72 (63 to 78)
Diastolic, Dose 2 (D30 H6)	72 (69 to 75)	70.5 (65.5 to 75.5)
Diastolic, Dose 2 (D30 H9)	75 (71 to 79)	75 (65.5 to 81.5)
Diastolic, Dose 2 (D30 H12)	73 (68 to 78)	72.5 (66.5 to 79.5)
Diastolic, Dose 2 (D30 H18)	70 (64 to 74)	71.5 (66 to 79)
Diastolic, Dose 2 (D31)	71 (67 to 77)	71 (65.5 to 80)
Diastolic, Dose 2 (D32)	77 (71 to 81)	74 (67 to 79)
Diastolic, Dose 2 (D33)	77 (71 to 81)	73 (70.5 to 79.5)
Diastolic, Dose 2 (D37)	76 (68 to 86)	74 (68.5 to 79.5)
Diastolic, Dose 2 (D60)	78 (72 to 84)	73 (67 to 81.5)

SecondaryLevels 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
Reported as:: Median · beats/minute

Levels of Heart Rate - Step 1
beats/minute	HBsAg/AS_1 Group	Engerix-B_1 Group
Heart rate, placebo (D-30)	75.5 (62 to 86)	70 (64 to 79)
Heart rate, placebo (D-30 H1.5)	75 (62 to 82)	73 (62 to 77)
Heart rate, placebo (D-30 H3)	69.5 (56 to 76)	63.5 (58 to 71)
Heart rate, placebo (D-30 H6)	69 (61 to 78)	69 (60 to 80)
Heart rate, placebo (D-30 H9)	66.5 (56 to 82)	65 (55 to 70)
Heart rate, placebo (D-30 H12)	71.5 (64 to 80)	72.5 (60 to 81)
Heart rate, placebo (D-30 H18)	66 (55 to 75)	70 (66 to 77)
Heart rate, placebo (D-29)	74.5 (63 to 82)	65.5 (62 to 70)
Heart rate, placebo (D-28)	70 (66 to 82)	73.5 (65 to 81)
Heart rate, placebo (D-27)	72 (66 to 80)	70 (65 to 81)
Heart rate, placebo (D-23)	72 (66 to 80)	66 (58 to 75)
Heart rate, Dose 1 (D0)	69.5 (62 to 80.5)	72 (62 to 79)
Heart rate, Dose 1 (D0 H1.5)	67.5 (62 to 76)	68 (62 to 77)
Heart rate, Dose 1 (D0 H6)	66 (60.5 to 80.5)	68 (65 to 79)
Heart rate, Dose 1 (D0 H12)	76 (66.5 to 83)	69 (61 to 79)
Heart rate, Dose 1 (D0 H18)	76 (60 to 83)	67 (60 to 77)
Heart rate, Dose 1 (D1)	72 (65 to 82)	67 (64 to 75)
Heart rate, Dose 1 (D2)	71.5 (60 to 80)	69 (65 to 79)
Heart rate, Dose 1 (D7)	74 (63 to 80.5)	71 (62 to 82)
Heart rate, Dose 2 (D30)	65 (59 to 77)	66.5 (58 to 76.5)
Heart rate, Dose 2 (D30 H1.5)	69 (60 to 78)	68.5 (57.5 to 79)
Heart rate, Dose 2 (D30 H3)	66 (55 to 74)	65 (60.5 to 76)
Heart rate, Dose 2 (D30 H6)	73 (64 to 80)	71.5 (62.5 to 81)
Heart rate, Dose 2 (D30 H9)	72 (57 to 81)	65.5 (59 to 79)
Heart rate, Dose 2 (D30 H12)	79 (66 to 85)	69.5 (63 to 81)
Heart rate, Dose 2 (D30 H18)	84.5 (79 to 90)	74.5 (66 to 80)
Heart rate, Dose 2 (D31)	81 (65 to 89)	66.5 (58 to 77.5)
Heart rate, Dose 2 (D32)	70 (63 to 83)	70.5 (62 to 77.5)
Heart rate, Dose 2 (D33)	69 (63 to 81)	70.5 (64.5 to 79)
Heart rate, Dose 2 (D37)	67 (59 to 79)	72.5 (61.5 to 79.5)
Heart rate, Dose 2 (D60)	72 (67 to 80)	71 (63.5 to 79.5)

SecondaryLevels 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
Reported as:: Median · breaths/min

Levels of Respiratory Rate - Step 1
breaths/min	HBsAg/AS_1 Group	Engerix-B_1 Group
Respiratory Rate, placebo (D-30)	14 (12 to 16)	13 (12 to 16)
Respiratory Rate, placebo (D-30 H1.5)	13 (12 to 15)	14.5 (13 to 16)
Respiratory Rate, placebo (D-30 H3)	13 (12 to 15)	14 (12 to 15)
Respiratory Rate, placebo (D-30 H6)	12.5 (12 to 16)	14 (13 to 16)
Respiratory Rate, placebo (D-30 H9)	13 (12 to 15)	15 (13 to 16)
Respiratory Rate, placebo (D-30 H12)	14 (12 to 15)	14.5 (13 to 15)
Respiratory Rate, placebo (D-30 H18)	13 (12 to 14)	12 (11 to 14)
Respiratory Rate, placebo (D-29)	13.5 (12 to 16)	14 (13 to 15)
Respiratory Rate, placebo (D-28)	14 (12 to 16)	14 (13 to 16)
Respiratory Rate, placebo (D-27)	14 (12 to 14)	14 (13 to 14)
Respiratory Rate, placebo (D-23)	14 (12 to 15)	14 (13 to 15)
Respiratory Rate, Dose 1 (D0)	14 (12.5 to 15.5)	14 (12 to 15)
Respiratory Rate, Dose 1 (D0 H1.5)	14 (12 to 15)	14 (13 to 15)
Respiratory Rate, Dose 1 (D0 H6)	14 (13 to 15)	14 (13 to 15)
Respiratory Rate, Dose 1 (D0 H12)	13.5 (12 to 14)	14 (13 to 14)
Respiratory Rate, Dose 1 (D0 H18)	13 (12 to 15)	14 (13 to 15)
Respiratory Rate, Dose 1 (D1)	14 (12 to 15)	14 (13 to 14)
Respiratory Rate, Dose 1 (D2)	14 (13 to 14.5)	14 (12 to 15)
Respiratory Rate, Dose 1 (D7)	13.5 (13 to 14.5)	13 (13 to 14)
Respiratory Rate, Dose 2 (D30)	14 (12 to 15)	14 (12 to 16)
Respiratory Rate, Dose 2 (D30 H1.5)	14 (13 to 15)	14 (13 to 15)
Respiratory Rate, Dose 2 (D30 H3)	14 (12 to 15)	14 (12 to 15)
Respiratory Rate, Dose 2 (D30 H6)	13 (12 to 15)	14 (12 to 15)
Respiratory Rate, Dose 2 (D30 H9)	14 (12 to 15)	13.5 (12.5 to 14)
Respiratory Rate, Dose 2 (D30 H12)	14 (12 to 15)	14 (13 to 15)
Respiratory Rate, Dose 2 (D30 H18)	14 (12 to 15)	14 (14 to 15)
Respiratory Rate, Dose 2 (D31)	13 (12 to 15)	14 (12 to 15)
Respiratory Rate, Dose 2 (D32)	14 (12 to 14)	14 (13 to 15)
Respiratory Rate, Dose 2 (D33)	13 (12 to 14)	14 (13 to 15)
Respiratory Rate, Dose 2 (D37)	14 (12 to 16)	14 (12.5 to 15)
Respiratory Rate, Dose 2 (D60)	14 (12 to 15)	14 (13 to 16)

SecondaryLevels 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
Reported as:: Median · mmHg

Levels of Systolic Pressure - Step 1
mmHg	HBsAg/AS_1 Group	Engerix-B_1 Group
Systolic, placebo (D-30)	123.5 (112 to 130)	116 (106 to 125)
Systolic, placebo (D-30 H1.5)	117 (111 to 124)	114 (103 to 124)
Systolic, placebo (D-30 H3)	117.5 (112 to 126)	114 (105 to 118)
Systolic, placebo (D-30 H6)	118 (113 to 124)	112 (105 to 124)
Systolic, placebo (D-30 H9)	120.5 (112 to 131)	114.5 (106 to 123)
Systolic, placebo (D-30 H12)	121.5 (112 to 129)	112 (105 to 125)
Systolic, placebo (D-30 H18)	111 (106 to 122)	106 (96 to 118)
Systolic, placebo (D-29)	116.5 (111 to 124)	112 (104 to 122)
Systolic, placebo (D-28)	121 (110 to 124)	114 (103 to 121)
Systolic, placebo (D-27)	119 (112 to 124)	115.5 (109 to 121)
Systolic, placebo (D-23)	118 (110 to 123)	115 (104 to 122)
Systolic, Dose 1 (D0)	118 (112 to 122.5)	114 (108 to 124)
Systolic, Dose 1 (D0 H1.5)	116 (110.5 to 121.5)	109 (102 to 119)
Systolic, Dose 1 (D0 H6)	117 (111 to 121.5)	112 (103 to 117)
Systolic, Dose 1 (D0 H12)	115 (110 to 126)	114 (107 to 120)
Systolic, Dose 1 (D0 H18)	112 (104 to 121)	105 (99 to 122)
Systolic, Dose 1 (D1)	114 (108.5 to 119)	114 (104 to 123)
Systolic, Dose 1 (D2)	115 (110 to 124)	111 (103 to 118)
Systolic, Dose 1 (D7)	116 (111 to 120.5)	113 (107 to 123)
Systolic, Dose 2 (D30)	115 (112 to 121)	112.5 (106.5 to 122.5)
Systolic, Dose 2 (D30 H1.5)	115 (108 to 124)	109.5 (102 to 117.5)
Systolic, Dose 2 (D30 H3)	116 (111 to 124)	113 (103 to 120.5)
Systolic, Dose 2 (D30 H6)	117 (107 to 122)	112 (103.5 to 118)
Systolic, Dose 2 (D30 H9)	117 (108 to 121)	116 (108.5 to 124)
Systolic, Dose 2 (D30 H12)	116 (109 to 125)	116.5 (105 to 122)
Systolic, Dose 2 (D30 H18)	109.5 (102 to 115)	107 (100 to 122)
Systolic, Dose 2 (D31)	114 (108 to 123)	109.5 (104 to 119)
Systolic, Dose 2 (D32)	116 (113 to 120)	110.5 (103 to 115.5)
Systolic, Dose 2 (D33)	116 (112 to 122)	111.5 (106 to 119.5)
Systolic, Dose 2 (D37)	120 (108 to 126)	112 (106 to 124.5)
Systolic, Dose 2 (D60)	120 (109 to 125)	115 (106.5 to 122.5)

SecondaryAnti-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)
Reported as:: Geometric mean · mIU/mL

Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno
mIU/mL	HBsAg/AS_2 Group	Engerix-B_2 Group
Anti-HBs, PRE	3.1 (3.1 to 3.1)	3.1 (3.1 to 3.1)
Anti-HBs, D44	8447.1 (4040.7 to 17658.9)	—
Anti-HBs, D194	—	1996.3 (143.8 to 27707.6)

SecondaryAnti-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)
Reported as:: Geometric mean · mIU/mL

Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence
mIU/mL	HBsAg/AS_2 Group	Engerix-B_2 Group
Anti-HBs, PRE	3.1 (3.1 to 3.1)	3.1 (3.1 to 3.1)
Anti-HBs, D44	8447.1 (4040.7 to 17658.9)	—
Anti-HBs, D194	—	2454.9 (311.4 to 19354.5)

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Participants	HBsAg/AS_2 Group	Engerix-B_2 Group
Any Pain, Dose 1	10	3
Grade 3 Pain, Dose 1	0	0
Any Redness, Dose 1	3	0
Grade 3 Redness, Dose 1	0	0
Any Swelling, Dose 1	2	0
Grade 3 Swelling, Dose 1	0	0
Any Pain, Dose 2	10	1
Grade 3 Pain, Dose 2	2	0
Any Redness, Dose 2	2	0
Grade 3 Redness, Dose 2	0	0
Any Swelling, Dose 2	3	0
Grade 3 Swelling, Dose 2	0	0
Any Pain, Dose 3	—	1
Grade 3 Pain, Dose 3	—	0
Any Redness, Dose 3	—	0
Grade 3 Redness, Dose 3	—	0
Any Swelling, Dose 3	—	0
Grade 3 Swelling, Dose 3	—	0
Any Pain, Across doses	10	4
Grade 3 Pain, Across doses	2	0
Any Redness, Across doses	4	0
Grade 3 Redness, Across doses	0	0
Any Swelling, Across doses	3	0
Grade 3 Swelling, Across doses	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Participants	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group
Any Pain, Dose 1	28	10
Grade 3 Pain, Dose 1	0	0
Any Redness, Dose 1	9	1
Grade 3 Redness, Dose 1	0	0
Any Swelling, Dose 1	6	0
Grade 3 Swelling, Dose 1	0	0
Any Pain, Dose 2	25	7
Grade 3 Pain, Dose 2	2	1
Any Redness, Dose 2	7	0
Grade 3 Redness, Dose 2	1	0
Any Swelling, Dose 2	4	0
Grade 3 Swelling, Dose 2	0	0
Any Pain, Dose 3	—	1
Grade 3 Pain, Dose 3	—	0
Any Redness, Dose 3	—	0
Grade 3 Redness, Dose 3	—	0
Any Swelling, Dose 3	—	0
Grade 3 Swelling, Dose 3	—	0
Any Pain, Across doses	31	12
Grade 3 Pain, Across doses	2	1
Any Redness, Across doses	12	1
Grade 3 Redness, Across doses	1	0
Any Swelling, Across doses	7	0
Grade 3 Swelling, Across doses	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Participants	HBsAg/AS_2 Group	Engerix-B_2 Group
Any Fatigue, Dose 1	8	3
Grade 3 Fatigue, Dose 1	1	0
Related Fatigue, Dose 1	7	2
Any Gastrointestinal Symptoms, Dose 1	5	3
Grade 3 Gastrointestinal Symptoms, Dose 1	1	0
Related Gastrointestinal Symptoms, Dose 1	5	3
Any Headache, Dose 1	7	4
Grade 3 Headache, Dose 1	1	0
Related Headache, Dose 1	7	3
Any Malaise, Dose 1	5	0
Grade 3 Malaise, Dose 1	1	0
Related Malaise, Dose 1	5	0
Any Myalgia, Dose 1	7	1
Grade 3 Myalgia, Dose 1	0	0
Related Myalgia, Dose 1	7	1
Any Shivering, Dose 1	2	1
Grade 3 Shivering, Dose 1	1	0
Related Shivering, Dose 1	2	1
Any Temperature, Dose 1	3	1
Grade 3 Temperature, Dose 1	0	0
Related Temperature, Dose 1	3	0
Any Fatigue, Dose 2	7	1
Grade 3 Fatigue, Dose 2	1	0
Related Fatigue, Dose 2	7	1
Any Gastrointestinal Symptoms, Dose 2	3	0
Grade 3 Gastrointestinal Symptoms, Dose 2	1	0
Related Gastrointestinal Symptoms, Dose 2	3	0
Any Headache, Dose 2	6	0
Grade 3 Headache, Dose 2	3	0
Related Headache, Dose 2	6	0
Any Malaise, Dose 2	7	0
Grade 3 Malaise, Dose 2	1	0
Related Malaise, Dose 2	7	0
Any Myalgia, Dose 2	9	0
Grade 3 Myalgia, Dose 2	0	0
Related Myalgia, Dose 2	9	0
Any Shivering, Dose 2	5	0
Grade 3 Shivering, Dose 2	0	0
Related Shivering, Dose 2	5	0
Any Temperature, Dose 2	4	2
Grade 3 Temperature, Dose 2	0	0
Related Temperature, Dose 2	1	0
Any Fatigue, Dose 3	—	1
Grade 3 Fatigue, Dose 3	—	0
Related Fatigue, Dose 3	—	1
Any Gastrointestinal Symptoms, Dose 3	—	1
Grade 3 Gastrointestinal Symptoms, Dose 3	—	0
Related Gastrointestinal Symptoms, Dose 3	—	1
Any Headache, Dose 3	—	2
Grade 3 Headache, Dose 3	—	0
Related Headache, Dose 3	—	2
Any Malaise, Dose 3	—	0
Grade 3 Malaise, Dose 3	—	0
Related Malaise, Dose 3	—	0
Any Myalgia, Dose 3	—	0
Grade 3 Myalgia, Dose 3	—	0
Related Myalgia, Dose 3	—	0
Any Shivering, Dose 3	—	0
Grade 3 Shivering, Dose 3	—	0
Related Shivering, Dose 3	—	0
Any Temperature, Dose 3	—	0
Grade 3 Temperature, Dose 3	—	0
Related Temperature, Dose 3	—	0
Any Fatigue, Across doses	8	3
Grade 3 Fatigue, Across doses	2	0
Related Fatigue, Across doses	8	2
Any Gastrointestinal Symptoms, Across doses	6	4
Grade 3 Gastrointestinal Symptoms, Across doses	2	0
Related Gastrointestinal Symptoms, Across doses	6	4
Any Headache, Across doses	9	5
Grade 3 Headache, Across doses	4	0
Related Headache, Across doses	9	4
Any Malaise, Across doses	7	0
Grade 3 Malaise, Across doses	2	0
Related Malaise, Across doses	7	0
Any Myalgia, Across doses	9	1
Grade 3 Myalgia, Across doses	0	0
Related Myalgia, Across doses	9	1
Any Shivering, Across doses	6	1
Grade 3 Shivering, Across doses	1	0
Related Shivering, Across doses	6	1
Any Temperature, Across doses	6	3
Grade 3 Temperature, Across doses	0	0
Related Temperature, Across doses	3	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Participants	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group
Any Fatigue, Dose 1	11	9
Grade 3 Fatigue, Dose 1	2	0
Related Fatigue, Dose 1	9	8
Any Gastrointestinal Symptoms, Dose 1	9	9
Grade 3 Gastrointestinal Symptoms, Dose 1	1	1
Related Gastrointestinal Symptoms, Dose 1	9	6
Any Headache, Dose 1	21	9
Grade 3 Headache, Dose 1	1	1
Related Headache, Dose 1	18	7
Any Malaise, Dose 1	9	2
Grade 3 Malaise, Dose 1	1	0
Related Malaise, Dose 1	9	2
Any Myalgia, Dose 1	17	2
Grade 3 Myalgia, Dose 1	0	0
Related Myalgia, Dose 1	16	2
Any Shivering, Dose 1	4	1
Grade 3 Shivering, Dose 1	1	0
Related Shivering, Dose 1	4	1
Any Fatigue, Dose 2	17	9
Grade 3 Fatigue, Dose 2	2	0
Related Fatigue, Dose 2	17	8
Any Gastrointestinal Symptoms, Dose 2	7	5
Grade 3 Gastrointestinal Symptoms, Dose 2	1	3
Related Gastrointestinal Symptoms, Dose 2	7	5
Any Headache, Dose 2	20	5
Grade 3 Headache, Dose 2	3	1
Related Headache, Dose 2	20	5
Any Malaise, Dose 2	14	6
Grade 3 Malaise, Dose 2	3	1
Related Malaise, Dose 2	14	6
Any Myalgia, Dose 2	19	3
Grade 3 Myalgia, Dose 2	0	0
Related Myalgia, Dose 2	19	1
Any Shivering, Dose 2	14	2
Grade 3 Shivering, Dose 2	0	0
Related Shivering, Dose 2	14	2
Any Fatigue, Dose 3	—	1
Grade 3 Fatigue, Dose 3	—	0
Related Fatigue, Dose 3	—	1
Any Gastrointestinal Symptoms, Dose 3	—	1
Grade 3 Gastrointestinal Symptoms, Dose 3	—	0
Related Gastrointestinal Symptoms, Dose 3	—	1
Any Headache, Dose 3	—	2
Grade 3 Headache, Dose 3	—	0
Related Headache, Dose 3	—	2
Any Malaise, Dose 3	—	0
Grade 3 Malaise, Dose 3	—	0
Related Malaise, Dose 3	—	0
Any Myalgia, Dose 3	—	0
Grade 3 Myalgia, Dose 3	—	0
Related Myalgia, Dose 3	—	0
Any Shivering, Dose 3	—	0
Grade 3 Shivering, Dose 3	—	0
Related Shivering, Dose 3	—	0
Any Fatigue, Across doses	18	12
Grade 3 Fatigue, Across doses	4	0
Related Fatigue, Across doses	18	11
Any Gastrointestinal Symptoms, Across doses	14	12
Grade 3 Gastrointestinal Symptoms, Across doses	2	4
Related Gastrointestinal Symptoms, Across doses	14	11
Any Headache, Across doses	26	11
Grade 3 Headache, Across doses	4	1
Related Headache, Across doses	24	10
Any Malaise, Across doses	15	7
Grade 3 Malaise, Across doses	4	1
Related Malaise, Across doses	15	7
Any Myalgia, Across doses	23	4
Grade 3 Myalgia, Across doses	0	0
Related Myalgia, Across doses	22	3
Any Shivering, Across doses	16	3
Grade 3 Shivering, Across doses	1	0
Related Shivering, Across doses	16	3

SecondaryNumber of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2

Time frame:: Within the 28-day (Days 0-27) and post-vaccination period
Reported as:: Count of participants · Participants

Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2
Participants	HBsAg/AS_2 Group	Engerix-B_2 Group
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2	5	4

SecondaryNumber of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step

Time frame:: Within the 28-day (Days 0-27) post-vaccination period.
Reported as:: Count of participants · Participants

Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step
Participants	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step	20	19

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Serious Adverse Events (SAEs) - Step 2
Participants	HBsAg/AS_2 Group	Engerix-B_2 Group
Number of Subjects With Serious Adverse Events (SAEs) - Step 2	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step
Participants	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group
Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step	0	1

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2
Participants	HBsAg/AS_2 Group	Engerix-B_2 Group
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step
Participants	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step	0	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2
Participants	HBsAg/AS_2 Group	Engerix-B_2 Group
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2	2	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step
Participants	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step	2	1

SecondaryLevels 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
Reported as:: Median · U/L

Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
U/L	HBsAg/AS_2 Group	Engerix-B_2 Group
ALT, PRE	27.5 (23 to 33)	31 (28 to 38)
ALT, D30	25.5 (25 to 31)	—
ALT, D32	27 (20 to 36)	—
ALT, D37	23 (18 to 31)	—
ALT, D60	30 (23 to 33)	—
ALT, D180	—	34.5 (27 to 45)
ALT, D182	—	31 (25 to 42)
ALT, D187	—	34 (29 to 40)
ALT, D210	—	29.5 (22 to 48)

SecondaryLevels 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
Reported as:: Median · U/L

Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
U/L	HBsAg/AS_2 Group	Engerix-B_2 Group
AST, PRE	22.5 (21 to 24)	28 (23 to 38)
AST, D30	22.5 (20 to 26)	—
AST, D32	24 (22 to 26)	—
AST, D37	20.5 (18 to 24)	—
AST, D60	21.5 (18 to 31)	—
AST, D180	—	25 (18 to 43)
AST, D182	—	29 (23 to 39)
AST, D187	—	25 (20 to 36)
AST, D210	—	22.5 (20 to 28)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Basophils in Blood Samples - Step 2
billion cells/L	HBsAg/AS_2 Group	Engerix-B_2 Group
Basophils, PRE	0.04 (0.02 to 0.05)	0.03 (0.02 to 0.04)
Basophils, D30	0.02 (0.01 to 0.07)	—
Basophils, D32	0.04 (0.02 to 0.05)	—
Basophils, D37	0.03 (0.01 to 0.06)	—
Basophils, D60	0.05 (0.02 to 0.06)	—
Basophils, D180	—	0.02 (0.01 to 0.04)
Basophils, D182	—	0.02 (0.01 to 0.04)
Basophils, D187	—	0.03 (0.02 to 0.05)
Basophils, D210	—	0.03 (0.01 to 0.04)

SecondaryLevels 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
Reported as:: Median · mg/L

Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
mg/L	HBsAg/AS_2 Group	Engerix-B_2 Group
CRP, PRE	5.55 (5 to 6.8)	5.8 (5 to 9.5)
CRP, D2	24.2 (16.6 to 32.7)	5 (5 to 8.8)
CRP, D30	6.8 (5.1 to 8.2)	—
CRP, D31	20.45 (10.4 to 21.9)	—
CRP, D32	33.75 (12.7 to 44.6)	—
CRP, D37	6.7 (5.5 to 10)	—
CRP, D60	5 (5 to 6.2)	—
CRP, D180	—	5.25 (5 to 6.8)
CRP, D181	—	5 (5 to 6)
CRP, D182	—	5 (5 to 7.3)
CRP, D187	—	5 (5 to 6.7)
CRP, D210	—	5 (5 to 7.8)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Eosinophils in Blood Samples - Step 2
billion cells/L	HBsAg/AS_2 Group	Engerix-B_2 Group
Eosinophils, PRE	0.16 (0.09 to 0.23)	0.18 (0.1 to 0.29)
Eosinophils, D30	0.17 (0.12 to 0.23)	—
Eosinophils, D32	0.25 (0.17 to 0.33)	—
Eosinophils, D37	0.19 (0.11 to 0.26)	—
Eosinophils, D60	0.2 (0.09 to 0.26)	—
Eosinophils, D180	—	0.14 (0.1 to 0.2)
Eosinophils, D182	—	0.17 (0.11 to 0.19)
Eosinophils, D187	—	0.18 (0.16 to 0.27)
Eosinophils, D210	—	0.16 (0.09 to 0.26)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of White Blood Cell (WBC) in Blood Samples - Step 2
billion cells/L	HBsAg/AS_2 Group	Engerix-B_2 Group
WBC, PRE	6.93 (5.51 to 9.67)	5.67 (5.13 to 7.46)
WBC, D30	6.41 (5.7 to 6.6)	—
WBC, D32	6.29 (5.24 to 8.09)	—
WBC, D37	6.37 (5.42 to 7.06)	—
WBC, D60	7.03 (5.65 to 8.5)	—
WBC, D180	—	6.02 (5.25 to 8.3)
WBC, D182	—	6.15 (5.6 to 8.1)
WBC, D187	—	7.35 (5.46 to 7.61)
WBC, D210	—	5.91 (4.48 to 8.53)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Lymphocytes in Blood Samples - Step 2
billion cells/L	HBsAg/AS_2 Group	Engerix-B_2 Group
Lymphocytes, D0	2.13 (1.83 to 2.55)	1.96 (1.69 to 2.37)
Lymphocytes, D30	2.14 (1.8 to 2.47)	—
Lymphocytes, D32	1.7 (1.47 to 1.82)	—
Lymphocytes, D37	2.12 (1.98 to 2.32)	—
Lymphocytes, D60	2.12 (1.72 to 2.34)	—
Lymphocytes, D180	—	1.93 (1.84 to 2.45)
Lymphocytes, D182	—	2.04 (1.75 to 2.44)
Lymphocytes, D187	—	2.07 (1.76 to 2.27)
Lymphocytes, D210	—	1.91 (1.46 to 2.94)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Monocytes in Blood Samples - Step 2
billion cells/L	HBsAg/AS_2 Group	Engerix-B_2 Group
Monocytes, D0	0.64 (0.47 to 0.74)	0.5 (0.28 to 0.69)
Monocytes, D30	0.54 (0.38 to 0.62)	—
Monocytes, D32	0.87 (0.8 to 1.07)	—
Monocytes, D37	0.47 (0.43 to 0.58)	—
Monocytes, D60	0.58 (0.49 to 0.68)	—
Monocytes, D180	—	0.46 (0.39 to 0.57)
Monocytes, D182	—	0.43 (0.42 to 0.66)
Monocytes, D187	—	0.44 (0.37 to 0.55)
Monocytes, D210	—	0.52 (0.34 to 0.62)

SecondaryLevels 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
Reported as:: Median · billion cells/L

Levels of Neutrophils in Blood Samples - Step 2
billion cells/L	HBsAg/AS_2 Group	Engerix-B_2 Group
Neutrophils, D0	4.02 (3.12 to 6.22)	3.11 (2.3 to 4.56)
Neutrophils, D30	3.41 (2.87 to 3.93)	—
Neutrophils, D32	3.42 (2.78 to 5.01)	—
Neutrophils, D37	3.22 (2.76 to 3.9)	—
Neutrophils, D60	4.18 (2.96 to 5.34)	—
Neutrophils, D180	—	3.29 (2.99 to 4.67)
Neutrophils, D182	—	3.16 (2.89 to 4.88)
Neutrophils, D187	—	3.9 (3.18 to 4.29)
Neutrophils, D210	—	3.28 (2.29 to 4.88)

SecondaryPlatelet 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
Reported as:: Median · billion cells/L

Platelet Count in Blood Samples - Step 2
billion cells/L	HBsAg/AS_2 Group	Engerix-B_2 Group
Platelets, D0	269 (255 to 312)	272 (215 to 322)
Platelets, D30	272.5 (215 to 330)	—
Platelets, D32	257 (204 to 303)	—
Platelets, D37	315.5 (286 to 330)	—
Platelets, D60	282 (257 to 323)	—
Platelets, D180	—	247 (237 to 276)
Platelets, D182	—	263 (248 to 274)
Platelets, D187	—	272 (260 to 280)
Platelets, D210	—	264.5 (214 to 314)

SecondaryLevels 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
Reported as:: Median · mg/dL

Levels of Total Bilirubin in Blood Samples - Step 2
mg/dL	HBsAg/AS_2 Group	Engerix-B_2 Group
Total Bilirubin, PRE	0.4 (0.4 to 0.8)	0.5 (0.3 to 0.7)
Total Bilirubin, D2	0.45 (0.4 to 0.6)	0.5 (0.3 to 1.5)
Total Bilirubin, D30	0.45 (0.3 to 0.8)	—
Total Bilirubin, D31	0.55 (0.4 to 1)	—
Total Bilirubin, D32	0.4 (0.2 to 0.6)	—
Total Bilirubin, D37	0.45 (0.3 to 0.6)	—
Total Bilirubin, D60	0.4 (0.3 to 0.6)	—
Total Bilirubin, D180	—	0.45 (0.4 to 0.6)
Total Bilirubin, D181	—	0.6 (0.4 to 0.7)
Total Bilirubin, D182	—	0.6 (0.5 to 0.7)
Total Bilirubin, D187	—	0.5 (0.5 to 0.7)
Total Bilirubin, D210	—	0.6 (0.5 to 0.7)

SecondaryLevels 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
Reported as:: Median · mmHg

Levels of Diastolic Blood Pressure - Step 2
mmHg	HBsAg/AS_2 Group	Engerix-B_2 Group
Diastolic, D0	74 (69 to 75)	70 (67 to 72)
Diastolic, D30 H0	74.5 (73 to 78)	—
Diastolic, D30 H6	71 (69 to 75)	—
Diastolic, D31	71.5 (68 to 78)	—
Diastolic, D32	71.5 (66 to 82)	—
Diastolic, D37	70 (69 to 76)	—
Diastolic, D60	72 (68 to 77)	—
Diastolic, D180 H0	—	69 (63 to 71)
Diastolic, D180 H6	—	68.5 (65 to 71)
Diastolic, D181	—	72 (66 to 75)
Diastolic, D182	—	70 (69 to 72)
Diastolic, D187	—	72 (64 to 77)
Diastolic, D210	—	71.5 (65 to 74)

SecondaryLevels 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
Reported as:: Median · beats/minute

Levels of Heart Rate - Step 2
beats/minute	HBsAg/AS_2 Group	Engerix-B_2 Group
Heart rate, PRE	72 (63 to 80)	70 (62 to 80)
Heart rate, D30 H0	70 (65 to 81)	—
Heart rate, D30 H6	68 (64 to 77)	—
Heart rate, D31	84 (70 to 90)	—
Heart rate, D32	73 (67 to 83)	—
Heart rate, D37	65 (56 to 73)	—
Heart rate, D60	65 (62 to 72)	—
Heart rate, D180 H0	—	71.5 (63 to 86)
Heart rate, D180 H6	—	70 (58 to 80)
Heart rate, D181	—	81 (73 to 91)
Heart rate, D182	—	72 (71 to 83)
Heart rate, D187	—	78 (67 to 84)
Heart rate, D210	—	76.5 (68 to 79)

SecondaryLevels 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
Reported as:: Median · breaths/min

Levels of Respiratory Rate - Step 2
breaths/min	HBsAg/AS_2 Group	Engerix-B_2 Group
Respiratory rate, PRE	12 (12 to 14)	12 (12 to 14)
Respiratory rate, D30 H0	12.5 (11 to 13)	—
Respiratory rate, D30 H6	12 (12 to 14)	—
Respiratory rate, D31	13 (12 to 14)	—
Respiratory rate, D32	12 (12 to 13)	—
Respiratory rate, D37	13.5 (12 to 14)	—
Respiratory rate, D60	12 (12 to 13)	—
Respiratory rate, D180 H0	—	12.5 (12 to 15)
Respiratory rate, D180 H6	—	12.5 (12 to 14)
Respiratory rate, D181	—	12 (12 to 14)
Respiratory rate, D182	—	13 (12 to 14)
Respiratory rate, D187	—	13 (12 to 15)
Respiratory rate, D210	—	13.5 (12 to 15)

SecondaryLevels 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
Reported as:: Median · mmHg

Levels of Systolic Pressure - Step 2
mmHg	HBsAg/AS_2 Group	Engerix-B_2 Group
Systolic, PRE	114 (110 to 116)	112 (103 to 115)
Systolic, D30 H0	114 (109 to 118)	—
Systolic, D30 H6	116 (104 to 121)	—
Systolic, D31	112 (108 to 113)	—
Systolic, D32	111.5 (102 to 116)	—
Systolic, D37	108.5 (105 to 117)	—
Systolic, D60	113 (104 to 122)	—
Systolic, D180 H0	—	111.5 (105 to 119)
Systolic, D180 H6	—	111.5 (108 to 114)
Systolic, D181	—	115 (112 to 129)
Systolic, D182	—	117 (108 to 120)
Systolic, D187	—	112 (110 to 115)
Systolic, D210	—	112 (108 to 116)

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
Reported as:: Median · T cells/million cells

-Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
T cells/million cells	HBsAg/AS_1 Group	Engerix-B_1 Group
PRE	8 (1 to 52)	1 (1 to 18)
Day 44	4494 (2441 to 7494)	268 (76 to 509)

SecondaryFrequency 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
Reported as:: Median · T cells/ million cells

Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
T cells/ million cells	HBsAg/AS_1 Group	Engerix-B_1 Group
PRE	8 (1 to 52)	1 (1 to 21)
Day 44	4494 (2441 to 7494)	260 (33 to 527)
Day 180	1119 (748 to 2181)	34 (1 to 155)

SecondaryFrequency 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
Reported as:: Median · T cells/ million cells

Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
T cells/ million cells	HBsAg/AS_1 Group	Engerix-B_1 Group
PRE	1 (1 to 24)	1 (1 to 1)
Day 44	38 (1 to 108)	1 (1 to 33)

SecondaryFrequency 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
Reported as:: Median · T ceclls/ million cells

Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
T ceclls/ million cells	HBsAg/AS_1 Group	Engerix-B_1 Group
PRE	1 (1 to 24)	1 (1 to 1)
Day 44	38 (1 to 108)	1 (1 to 42)
Day 180	1 (1 to 17)	1 (1 to 31)

SecondaryNumber of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2

Time frame:: Up to 3 days post-placebo/vaccine administration.
Reported as:: Count of participants · Participants

Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Participants	HBsAg/AS_2 Group	Engerix-B_2 Group
Pain, Dose 2	8	0
Pain, Dose 3	0	1
Redness, Dose 2	5	0
Redness, Dose 3	0	0
Swelling, Dose 2	3	0
Swelling, Dose 3	0	0
Induration, Dose 2	1	0
Induration, Dose 3	0	0
Fever, Dose 2	0	0
Fever, Dose 3	0	0
Muscle stiffness, Dose 2	7	0
Muscle stiffness, Dose 3	0	1

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Participants	HBsAg/AS_1+2 Group
Pain	26
Redness	12
Swelling	7
Induration	2
Muscle stiffness	22

Adverse events

Collected over Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
HBsAg/AS_1+2 Group	0/38 (0%)	0/38 (0%)	16/38 (42.1%)
Engerix-B_1+2 Group	0/40 (0%)	1/40 (2.5%)	13/40 (32.5%)

Most frequent serious events

Most frequent serious events
Event	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group
CholecystitisHepatobiliary disorders	0/38	1/40

Most frequent other events

Most frequent other events
Event	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	6/38	1/40
NasopharyngitisInfections and infestations	5/38	1/40
HeadacheNervous system disorders	2/38	5/40
Back painMusculoskeletal and connective tissue disorders	3/38	0/40
DysmenorrhoeaReproductive system and breast disorders	0/38	3/40
Influenza like illnessGeneral disorders	2/38	0/40
Oral herpesInfections and infestations	2/38	1/40
FatigueGeneral disorders	0/38	2/40
MigraineNervous system disorders	0/38	2/40
ToothacheGastrointestinal disorders	0/38	2/40

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group	Total
Mean	39.2 ± 4.1	37.5 ± 5.9	38.4 ± 5.2

Sex: Female, Male
Sex: Female, Male(Participants)	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group	Total
Female	25	26	51
Male	15	15	30

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	HBsAg/AS_1+2 Group	Engerix-B_1+2 Group	Total
Geographic ancestry — African Heritage / African American	1	0	1
Geographic ancestry — White - Arabic / North African Heritage	1	2	3
Geographic ancestry — White - Caucasian / European Heritage	38	39	77

Study locations

1 site

GSK Investigational Site
Antwerpen, 2060, Belgium

References and documents

Publications

Burny W, Herve C, Caubet M, Yarzabal JP, Didierlaurent AM. Utility of urinary cytokine levels as predictors of the immunogenicity and reactogenicity of AS01-adjuvanted hepatitis B vaccine in healthy adults. Vaccine. 2022 Apr 26;40(19):2714-2722. doi: 10.1016/j.vaccine.2022.03.050. Epub 2022 Mar 30. PubMed 35367070 ↗
Burny W, Marchant A, Herve C, Callegaro A, Caubet M, Fissette L, Gheyle L, Legrand C, Ndour C, Tavares Da Silva F, van der Most R, Willems F, Didierlaurent AM, Yarzabal J; ECR-008 study group. Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans. Vaccine. 2019 Mar 28;37(14):2004-2015. doi: 10.1016/j.vaccine.2019.02.015. Epub 2019 Mar 5. PubMed 30850240 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01777295
Lead sponsor: GlaxoSmithKline
Collaborators: Region of Wallonia, Public Private Partnership with Institute for Medical Immunology (Universite Libre de Bruxelles)
Responsible party: Sponsor
First posted: Jan 28, 2013
Start date: Feb 25, 2013
Primary completion: May 17, 2016
Completion: Sep 13, 2016
Results posted: Jan 4, 2019
Last update: Jan 4, 2019

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

FDA-regulated drug: No
FDA-regulated device: No

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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

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