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    Clinical Trial Results:
    Development of read-outs to detect and characterise the early and adaptive immune responses in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals’ Adjuvant System

    Summary
    EudraCT number
    2012-001344-22
    Trial protocol
    BE  
    Global end of trial date
    13 Jun 2016

    Results information
    Results version number
    v3(current)
    This version publication date
    22 Jul 2018
    First version publication date
    14 Sep 2017
    Other versions
    v1 , v2
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    116640
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To detect and measure soluble mediators from the early immune response in plasma.
    Protection of trial subjects
    •All vaccinated subjects were observed closely for at least 30 minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction. Vaccines/products were administered by qualified and trained personnel. Vaccines/placebos were administered only to eligible subjects that had no contraindications to any components of the vaccines/placebos. Subjects were followed-up for up to one month for adverse events after the last vaccination/placebos administration and during the entire study period for serious adverse events.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 81
    Worldwide total number of subjects
    81
    EEA total number of subjects
    81
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    81
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The subject disposition refers to all subjects included in the Pooling of steps, with at least one vaccine administration documented.

    Pre-assignment
    Screening details
    During the screening period the following steps occurred: blood samples withdrawals to check eligibility criteria (HBV, hepatitis C virus [HCV], human immunodeficiency virus [HIV], haematology and blood chemistry), blood collection for innate immune assays, adaptive read-outs and urine samples collection

    Pre-assignment period milestones
    Number of subjects started
    81
    Number of subjects completed
    81

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject
    Blinding implementation details
    Single-blind up to Day 60 in each Step. Subjects were unblinded at the end of their Day 60 visit.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    HBsAg/AS_1+2 Group
    Arm description
    Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of placebo saline solution was administered intramuscularly into the deltoid region of the non-dominant arm at Day -30 in Step 1 of the study.

    Investigational medicinal product name
    Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The 2 vaccine doses were administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 30, in both Step 1 and Step 2 of the study.

    Arm title
    Engerix-B_1+2 Group
    Arm description
    Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
    Arm type
    Active comparator

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of placebo saline solution was administered intramuscularly into the deltoid region of the non-dominant arm at Day -30 in Step 1 of the study.

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    HBsAg/Alum
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The 3 doses of active comparator were administered intramuscularly into the deltoid region of the non-dominant arm at Day 0, Day 30 and Day 180, in both Step 1 and Step 2 of the study.

    Number of subjects in period 1
    HBsAg/AS_1+2 Group Engerix-B_1+2 Group
    Started
    40
    41
    Completed
    36
    38
    Not completed
    4
    3
         Investigator call for AEs check
    1
    -
         Pregnancy
    -
    1
         Personal problem
    1
    -
         Consent withdrawn by subject
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HBsAg/AS_1+2 Group
    Reporting group description
    Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.

    Reporting group title
    Engerix-B_1+2 Group
    Reporting group description
    Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.

    Reporting group values
    HBsAg/AS_1+2 Group Engerix-B_1+2 Group Total
    Number of subjects
    40 41
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.2 ± 4.1 37.5 ± 5.9 -
    Gender categorical
    Units: Subjects
        Female
    25 26 51
        Male
    15 15 30
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    1 0 1
        White - Arabic / North African Heritage
    1 2 3
        White - Caucasian / European Heritage
    38 39 77

    End points

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    End points reporting groups
    Reporting group title
    HBsAg/AS_1+2 Group
    Reporting group description
    Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.

    Reporting group title
    Engerix-B_1+2 Group
    Reporting group description
    Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.

    Subject analysis set title
    hbsag/as_1 group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.

    Subject analysis set title
    engerix-b_1 group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.

    Subject analysis set title
    hbsag/as_2 group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm

    Subject analysis set title
    engerix-b_2 group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.

    Primary: Concentrations of cytokines and chemokines - Step 1

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    End point title
    Concentrations of cytokines and chemokines - Step 1 [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    At Day -30 prior to product administration
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines and chemokines concentrations - Step 1

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    End point title
    Cytokines and chemokines concentrations - Step 1 [2]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -30 plus 1.5 Hours
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines and chemokines in Step 1

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    End point title
    Concentrations of cytokines and chemokines in Step 1 [3]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -30 plus 3 Hours
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines and chemokines during Step 1

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    End point title
    Concentrations of cytokines and chemokines during Step 1 [4]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -30 plus 6 Hours
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines/chemokines - Step 1

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    End point title
    Concentrations of cytokines/chemokines - Step 1 [5]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -30 plus 9 Hours
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines/chemokines in Step 1

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    End point title
    Concentrations of cytokines/chemokines in Step 1 [6]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -30 plus 12 Hours
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines/chemokines during Step 1

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    End point title
    Concentrations of cytokines/chemokines during Step 1 [7]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -30 plus 18 Hours
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    14
    11
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines and chemokines concentrations in Step 1

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    End point title
    Cytokines and chemokines concentrations in Step 1 [8]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -29
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines and chemokines concetrations during Step 1

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    End point title
    Cytokines and chemokines concetrations during Step 1 [9]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -28
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines/chemokines concentrations in Step 1

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    End point title
    Cytokines/chemokines concentrations in Step 1 [10]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -27
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    26
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines and chemokines concentrations during Step 1

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    End point title
    Cytokines and chemokines concentrations during Step 1 [11]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-placebo at Day -23
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines and chemokines - study Step 1

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    End point title
    Concentrations of cytokines and chemokines - study Step 1 [12]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Pre-dose1 at Day 0
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines and chemokines in Step 1 of study

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    End point title
    Concentrations of cytokines and chemokines in Step 1 of study [13]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose1 at Day 0 plus 1.5 Hours
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines and chemokines during Step 1 of study

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    End point title
    Concentrations of cytokines and chemokines during Step 1 of study [14]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose1 at Day 0 plus 6 Hours
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines and chemokines concentrations - study Step 1

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    End point title
    Cytokines and chemokines concentrations - study Step 1 [15]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose1 at Day 0 plus 12 Hours
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines and chemokines concentrations in Step 1 of study

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    End point title
    Cytokines and chemokines concentrations in Step 1 of study [16]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose1 at Day 0 plus 18 Hours
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    14
    11
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines and chemokines concentrations during Step 1 of study

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    End point title
    Cytokines and chemokines concentrations during Step 1 of study [17]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose1 at Day 1
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    26
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines/chemokines concentrations - study Step 1

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    End point title
    Cytokines/chemokines concentrations - study Step 1 [18]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose1 at Day 2
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines/chemokines concentrations in Step 1 of study

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    End point title
    Cytokines/chemokines concentrations in Step 1 of study [19]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose1 at Day 7
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Cytokines/chemokines concentrations during Step 1 of study

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    End point title
    Cytokines/chemokines concentrations during Step 1 of study [20]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose1 at Day 30
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines and chemokines - Step 1

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    End point title
    Plasma concentrations of cytokines and chemokines - Step 1 [21]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 30 plus 1.5 Hours
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines and chemokines - study Step 1

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    End point title
    Plasma concentrations of cytokines and chemokines - study Step 1 [22]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 30 plus 3 Hours
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    26
    24
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines and chemokines in Step 1 of study

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    End point title
    Plasma concentrations of cytokines and chemokines in Step 1 of study [23]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 30 plus 6 hours
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    26
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines and chemokines during Step 1 of study

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    End point title
    Plasma concentrations of cytokines and chemokines during Step 1 of study [24]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 30 plus 9 Hours
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    24
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines/chemokines during Step 1 of study

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    End point title
    Plasma concentrations of cytokines/chemokines during Step 1 of study [25]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 30 plus 12 Hours
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    25
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines/chemokines - Step 1 of study

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    End point title
    Plasma concentrations of cytokines/chemokines - Step 1 of study [26]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 30 plus 18 Hours
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    14
    11
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines/chemokines in Step 1 of study

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    End point title
    Plasma concentrations of cytokines/chemokines in Step 1 of study [27]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 31
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of plasma cytokines and chemokines - Step 1

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    End point title
    Concentrations of plasma cytokines and chemokines - Step 1 [28]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 32
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of plasma cytokines and chemokines in Step 1

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    End point title
    Concentrations of plasma cytokines and chemokines in Step 1 [29]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 33
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of plasma cytokines and chemokines during Step 1

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    End point title
    Concentrations of plasma cytokines and chemokines during Step 1 [30]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 37
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        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)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines and chemokines - Step 2

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    End point title
    Concentrations of cytokines and chemokines - Step 2 [31]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Pre-dose 1 at Day 0
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_2 group engerix-b_2 group
    Number of subjects analysed
    6
    9
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=6, 9]
    8100 (4200 to 8900)
    5400 (4400 to 5500)
        GM-CSF [N=6, 9]
    14 (14 to 14)
    14 (14 to 14)
        IFN-γ [N=6, 9]
    1.6 (1.6 to 1.6)
    1.6 (1.6 to 1.6)
        IL-10 [N=6, 9]
    3.3 (3.3 to 3.8)
    3.3 (3.3 to 3.3)
        IL-18 [N=6, 9]
    199.5 (175 to 377)
    179 (152 to 182)
        IL-2 [N=6, 9]
    5.9 (5.9 to 5.9)
    5.9 (5.9 to 5.9)
        IL-3 [N=6, 9]
    1.6 (1.6 to 1.6)
    1.6 (1.6 to 1.6)
        IL-4 [N=6, 9]
    9.4 (9.4 to 9.4)
    9.4 (9.4 to 9.4)
        IL-5 [N=6, 9]
    2.7 (2.7 to 2.7)
    2.7 (2.7 to 2.7)
        IL-6 [N=6, 9]
    1.6 (1.6 to 1.6)
    1.6 (1.6 to 1.6)
        IL-6r [N=6, 9]
    32000 (29000 to 36000)
    30000 (28000 to 36000)
        IL-7 [N=6, 9]
    8.2 (8.2 to 8.2)
    8.2 (8.2 to 8.2)
        IL-8 [N=6, 9]
    5.3 (3.5 to 11)
    4.4 (3.5 to 6.2)
        IP-10 [N=6, 9]
    300.5 (275 to 370)
    234 (166 to 278)
        MCP-1 [N=6, 9]
    86.5 (77 to 132)
    87 (67 to 96)
        MCP-2 [N=6, 9]
    22.5 (17 to 27)
    27 (19 to 30)
        MCP-4 [N=6, 9]
    1805 (1300 to 2010)
    2120 (1720 to 2260)
        MIG [N=0, 0]
    0 (0 to 0)
    0 (0 to 0)
        MIP-1 alpha [N=6, 9]
    18 (18 to 18)
    18 (18 to 18)
        MIP-1 beta [N=6, 9]
    234 (186 to 255)
    253 (200 to 300)
        MIP-3 alpha [N=6, 9]
    28.5 (23 to 64)
    29 (17 to 42)
        MPIF-1 [N=6, 9]
    1095 (820 to 1200)
    1100 (930 to 1200)
        TNF-alpha [N=6, 9]
    13 (13 to 13)
    13 (13 to 13)
        TNF-beta [N=6, 9]
    3 (3 to 3)
    3 (3 to 3)
    No statistical analyses for this end point

    Primary: Cytokines and chemokines concentrations - Step 2

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    End point title
    Cytokines and chemokines concentrations - Step 2 [32]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 1 at Day 1
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_2 group
    Number of subjects analysed
    7
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=7]
    7900 (4300 to 9100)
        GM-CSF [N=7]
    14 (14 to 14)
        IFN-γ [N=7]
    1.6 (1.6 to 1.6)
        IL-10 [N=7]
    3.8 (3.3 to 4.7)
        IL-18 [N=7]
    206 (182 to 260)
        IL-2 [N=7]
    5.9 (5.9 to 5.9)
        IL-3 [N=7]
    1.6 (1.6 to 1.6)
        IL-4 [N=7]
    9.4 (9.4 to 9.4)
        IL-5 [N=7]
    2.7 (2.7 to 2.7)
        IL-6 [N=7]
    1.7 (1.6 to 2.6)
        IL-6r [N=7]
    24000 (22000 to 33000)
        IL-7 [N=7]
    8.2 (8.2 to 8.2)
        IL-8 [N=7]
    3.9 (2.6 to 7.1)
        IP-10 [N=7]
    294 (199 to 390)
        MCP-1 [N=7]
    35 (27 to 114)
        MCP-2 [N=7]
    26 (20 to 29)
        MCP-4 [N=7]
    1240 (1130 to 1640)
        MIG [N=0]
    0 (0 to 0)
        MIP-1 alpha [N=7]
    18 (18 to 32)
        MIP-1 beta [N=7]
    318 (241 to 391)
        MIP-3 alpha [N=7]
    32 (17 to 46)
        MPIF-1 [N=7]
    1400 (1200 to 1500)
        TNF-alpha [N=7]
    13 (13 to 13)
        TNF-beta [N=7]
    3 (3 to 3)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines and chemokines during Step 2

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    End point title
    Concentrations of cytokines and chemokines during Step 2 [33]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 1 at Day 30
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_2 group
    Number of subjects analysed
    8
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=8]
    6200 (3600 to 8450)
        GM-CSF [N=8]
    14 (14 to 14)
        IFN-γ [N=8]
    1.6 (1.6 to 1.6)
        IL-10 [N=8]
    3.3 (3.3 to 3.6)
        IL-18 [N=8]
    166.5 (132.5 to 271.5)
        IL-2 [N=8]
    5.9 (5.9 to 5.9)
        IL-3 [N=8]
    1.6 (1.6 to 1.6)
        IL-4 [N=8]
    9.4 (9.4 to 11.2)
        IL-5 [N=8]
    2.7 (2.7 to 2.7)
        IL-6 [N=8]
    1.6 (1.6 to 1.7)
        IL-6r [N=8]
    29000 (24500 to 33500)
        IL-7 [N=8]
    8.2 (8.2 to 10.1)
        IL-8 [N=8]
    4.3 (3.1 to 8.4)
        IP-10 [N=8]
    231.5 (160.5 to 318.5)
        MCP-1 [N=8]
    46 (35 to 115.5)
        MCP-2 [N=8]
    19.5 (17 to 20.5)
        MCP-4 [N=8]
    1340 (1115 to 1450)
        MIG [N=0]
    0 (0 to 0)
        MIP-1 alpha [N=8]
    18 (18 to 18)
        MIP-1 beta [N=8]
    172 (158.5 to 196.5)
        MIP-3 alpha [N=8]
    25 (15 to 30.5)
        MPIF-1 [N=8]
    1200 (855 to 1400)
        TNF-alpha [N=8]
    13 (13 to 13)
        TNF-beta [N=8]
    3 (3 to 3)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines and chemokines in Step 2

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    End point title
    Concentrations of cytokines and chemokines in Step 2 [34]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose2 at Day 30 plus 6 Hours
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_2 group
    Number of subjects analysed
    7
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=7]
    5400 (3400 to 8300)
        GM-CSF [N=7]
    14 (14 to 14)
        IFN-γ [N=7]
    1.6 (1.6 to 1.6)
        IL-10 [N=7]
    3.3 (3.3 to 3.3)
        IL-18 [N=7]
    172 (150 to 247)
        IL-2 [N=7]
    5.9 (5.9 to 5.9)
        IL-3 [N=7]
    1.6 (1.6 to 1.6)
        IL-4 [N=7]
    9.4 (9.4 to 10)
        IL-5 [N=7]
    2.7 (2.7 to 2.7)
        IL-6 [N=7]
    3.7 (1.6 to 4.7)
        IL-6r [N=7]
    34000 (27000 to 43000)
        IL-7 [N=7]
    12 (8.2 to 21)
        IL-8 [N=7]
    6.1 (3.6 to 9.1)
        IP-10 [N=7]
    163 (128 to 205)
        MCP-1 [N=7]
    59 (27 to 86)
        MCP-2 [N=7]
    22 (18 to 25)
        MCP-4 [N=7]
    1330 (979 to 1540)
        MIG [N=0]
    0 (0 to 0)
        MIP-1 alpha [N=7]
    18 (18 to 18)
        MIP-1 beta [N=7]
    182 (154 to 266)
        MIP-3 alpha [N=7]
    21 (13 to 28)
        MPIF-1 [N=7]
    1300 (980 to 1700)
        TNF-alpha [N=7]
    13 (13 to 13)
        TNF-beta [N=7]
    3 (3 to 6.3)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines/chemokines - Step 2

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    End point title
    Concentrations of cytokines/chemokines - Step 2 [35]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 31
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_2 group
    Number of subjects analysed
    8
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=8]
    7450 (4600 to 10500)
        GM-CSF [N=8]
    14 (14 to 14)
        IFN-γ [N=8]
    6.2 (3.4 to 17.6)
        IL-10 [N=8]
    3.3 (3.3 to 4.4)
        IL-18 [N=8]
    234 (181 to 339.5)
        IL-2 [N=8]
    5.9 (5.9 to 5.9)
        IL-3 [N=8]
    1.6 (1.6 to 1.6)
        IL-4 [N=8]
    9.7 (9.4 to 10)
        IL-5 [N=8]
    2.7 (2.7 to 2.7)
        IL-6 [N=8]
    4 (2.2 to 5.7)
        IL-6r [N=8]
    30500 (27000 to 41500)
        IL-7 [N=8]
    10.1 (8.2 to 23.5)
        IL-8 [N=8]
    7.9 (7.3 to 10.9)
        IP-10 [N=8]
    737.5 (510 to 1270)
        MCP-1 [N=8]
    142.5 (104 to 153)
        MCP-2 [N=8]
    40.5 (32 to 72.5)
        MCP-4 [N=8]
    1330 (974 to 1780)
        MIG [N=0]
    0 (0 to 0)
        MIP-1 alpha [N=8]
    18 (18 to 18)
        MIP-1 beta [N=8]
    580 (359.5 to 780.5)
        MIP-3 alpha [N=8]
    28 (19 to 39.5)
        MPIF-1 [N=8]
    1750 (1500 to 1850)
        TNF-alpha [N=8]
    13 (13 to 13)
        TNF-beta [N=8]
    3 (3 to 3)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines/chemokines in Step 2

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    End point title
    Concentrations of cytokines/chemokines in Step 2 [36]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 37
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    hbsag/as_2 group
    Number of subjects analysed
    8
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=8]
    6550 (3250 to 8450)
        GM-CSF [N=8]
    14 (14 to 14)
        IFN-γ [N=8]
    1.6 (1.6 to 1.6)
        IL-10 [N=8]
    3.3 (3.3 to 3.8)
        IL-18 [N=8]
    232 (145.5 to 322)
        IL-2 [N=8]
    5.9 (5.9 to 5.9)
        IL-3 [N=8]
    1.6 (1.6 to 1.6)
        IL-4 [N=8]
    9.7 (9.4 to 14)
        IL-5 [N=8]
    2.7 (2.7 to 2.7)
        IL-6 [N=8]
    1.6 (1.6 to 1.7)
        IL-6r [N=8]
    28000 (26500 to 34500)
        IL-7 [N=8]
    8.2 (8.2 to 8.2)
        IL-8 [N=8]
    8.5 (6.7 to 9.7)
        IP-10 [N=8]
    170 (143 to 210)
        MCP-1 [N=8]
    72.5 (27 to 104)
        MCP-2 [N=8]
    18.5 (15 to 23)
        MCP-4 [N=8]
    1275 (881.5 to 1635)
        MIG [N=0]
    0 (0 to 0)
        MIP-1 alpha [N=8]
    18 (18 to 18)
        MIP-1 beta [N=8]
    174 (152.5 to 187.5)
        MIP-3 alpha [N=8]
    17 (11.5 to 94)
        MPIF-1 [N=8]
    1100 (995 to 1450)
        TNF-alpha [N=8]
    13 (13 to 13)
        TNF-beta [N=8]
    3 (3 to 11.2)
    No statistical analyses for this end point

    Primary: Concentrations of cytokines/chemokines during Step 2

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    End point title
    Concentrations of cytokines/chemokines during Step 2 [37]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 2 at Day 180
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    engerix-b_2 group
    Number of subjects analysed
    9
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=9]
    4900 (4300 to 5800)
        GM-CSF [N=9]
    14 (14 to 14)
        IFN-γ [N=9]
    1.6 (1.6 to 1.6)
        IL-10 [N=9]
    3.3 (3.3 to 3.3)
        IL-18 [N=9]
    159 (144 to 190)
        IL-2 [N=9]
    5.9 (5.9 to 5.9)
        IL-3 [N=9]
    1.6 (1.6 to 1.6)
        IL-4 [N=9]
    9.4 (9.4 to 9.4)
        IL-5 [N=9]
    2.7 (2.7 to 2.7)
        IL-6 [N=9]
    1.6 (1.6 to 1.6)
        IL-6r [N=9]
    24000 (24000 to 32000)
        IL-7 [N=9]
    8.2 (8.2 to 8.2)
        IL-8 [N=9]
    4.4 (3.5 to 5.3)
        IP-10 [N=9]
    156 (121 to 260)
        MCP-1 [N=9]
    77 (57 to 77)
        MCP-2 [N=9]
    20 (14 to 27)
        MCP-4 [N=9]
    1640 (1540 to 1810)
        MIG [N=0]
    0 (0 to 0)
        MIP-1 alpha [N=9]
    18 (18 to 18)
        MIP-1 beta [N=9]
    189 (177 to 257)
        MIP-3 alpha [N=9]
    25 (13 to 32)
        MPIF-1 [N=9]
    920 (830 to 970)
        TNF-alpha [N=9]
    13 (13 to 13)
        TNF-beta [N=9]
    3 (3 to 3)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines and chemokines - study Step 2

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    End point title
    Plasma concentrations of cytokines and chemokines - study Step 2 [38]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose2 at Day 30 plus 6 Hours
    Notes
    [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    engerix-b_2 group
    Number of subjects analysed
    9
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=9]
    4600 (4100 to 5800)
        GM-CSF [N=9]
    14 (14 to 14)
        IFN-γ [N=9]
    1.6 (1.6 to 1.6)
        IL-10 [N=9]
    3.3 (3.3 to 3.3)
        IL-18 [N=9]
    144 (133 to 152)
        IL-2 [N=9]
    5.9 (5.9 to 5.9)
        IL-3 [N=9]
    1.6 (1.6 to 1.6)
        IL-4 [N=9]
    9.4 (9.4 to 9.4)
        IL-5 [N=9]
    2.7 (2.7 to 2.7)
        IL-6 [N=9]
    1.6 (1.6 to 1.6)
        IL-6r [N=9]
    25000 (24000 to 30000)
        IL-7 [N=9]
    8.2 (8.2 to 8.2)
        IL-8 [N=9]
    3.5 (2.6 to 4.4)
        IP-10 [N=9]
    145 (105 to 214)
        MCP-1 [N=9]
    46 (35 to 67)
        MCP-2 [N=9]
    22 (15 to 26)
        MCP-4 [N=9]
    1640 (1350 to 1720)
        MIG [N=0]
    0 (0 to 0)
        MIP-1 alpha [N=9]
    18 (18 to 18)
        MIP-1 beta [N=9]
    193 (175 to 211)
        MIP-3 alpha [N=9]
    21 (15 to 25)
        MPIF-1 [N=9]
    890 (840 to 1100)
        TNF-alpha [N=9]
    13 (13 to 13)
        TNF-beta [N=9]
    3 (3 to 3)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines and chemokines in Step 2 of study

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    End point title
    Plasma concentrations of cytokines and chemokines in Step 2 of study [39]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 3 at Day 180 plus 6 Hours
    Notes
    [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    engerix-b_2 group
    Number of subjects analysed
    8
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=8]
    4900 (4300 to 5900)
        GM-CSF [N=8]
    14 (14 to 14)
        IFN-γ [N=8]
    1.6 (1.6 to 1.6)
        IL-10 [N=8]
    3.3 (3.3 to 3.8)
        IL-18 [N=8]
    152 (140.5 to 192)
        IL-2 [N=8]
    5.9 (5.9 to 5.9)
        IL-3 [N=8]
    1.6 (1.6 to 1.6)
        IL-4 [N=8]
    9.4 (9.4 to 11.2)
        IL-5 [N=8]
    2.7 (2.7 to 2.7)
        IL-6 [N=8]
    1.6 (1.6 to 1.6)
        IL-6r [N=8]
    24500 (22500 to 31500)
        IL-7 [N=8]
    8.2 (8.2 to 8.2)
        IL-8 [N=8]
    3.5 (2.6 to 3.5)
        IP-10 [N=8]
    152 (119.5 to 211.5)
        MCP-1 [N=8]
    67 (35 to 86.5)
        MCP-2 [N=8]
    19.5 (13 to 25.5)
        MCP-4 [N=8]
    1720 (1390 to 1790)
        MIG [N=0]
    0 (0 to 0)
        MIP-1 alpha [N=8]
    18 (18 to 18)
        MIP-1 beta [N=8]
    173.5 (166.5 to 213)
        MIP-3 alpha [N=8]
    17 (15 to 21)
        MPIF-1 [N=8]
    875 (745 to 1100)
        TNF-alpha [N=8]
    13 (13 to 13)
        TNF-beta [N=8]
    3 (3 to 3)
    No statistical analyses for this end point

    Primary: Plasma concentrations of cytokines and chemokines during Step 2 of study

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    End point title
    Plasma concentrations of cytokines and chemokines during Step 2 of study [40]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Post-dose 3 at Day 187
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    engerix-b_2 group
    Number of subjects analysed
    5
    Units: pg/mL
    median (inter-quartile range (Q1-Q3))
        E-selectin [N=5]
    4600 (4200 to 5500)
        GM-CSF [N=5]
    14 (14 to 14)
        IFN-γ [N=5]
    1.6 (1.6 to 1.6)
        IL-10 [N=5]
    3.3 (3.3 to 3.3)
        IL-18 [N=5]
    163 (137 to 167)
        IL-2 [N=5]
    5.9 (5.9 to 5.9)
        IL-3 [N=5]
    1.6 (1.6 to 1.6)
        IL-4 [N=5]
    9.4 (9.4 to 9.4)
        IL-5 [N=5]
    2.7 (2.7 to 2.7)
        IL-6 [N=5]
    1.6 (1.6 to 1.6)
        IL-6r [N=5]
    30000 (26000 to 35000)
        IL-7 [N=5]
    8.2 (8.2 to 8.2)
        IL-8 [N=5]
    3.5 (3.5 to 4.4)
        IP-10 [N=5]
    201 (107 to 201)
        MCP-1 [N=5]
    35 (35 to 35)
        MCP-2 [N=5]
    22 (17 to 25)
        MCP-4 [N=5]
    1810 (1720 to 2120)
        MIG [N=0]
    0 (0 to 0)
        MIP-1 alpha [N=5]
    18 (18 to 18)
        MIP-1 beta [N=5]
    175 (175 to 193)
        MIP-3 alpha [N=5]
    17 (17 to 25)
        MPIF-1 [N=5]
    820 (750 to 970)
        TNF-alpha [N=5]
    13 (13 to 13)
        TNF-beta [N=5]
    3 (3 to 3)
    No statistical analyses for this end point

    Secondary: Anti-Hepatitis B surface (anti-HBs) antibody concentrations in serum - Step 1

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    End point title
    Anti-Hepatitis B surface (anti-HBs) antibody concentrations in serum - Step 1
    End point description
    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).
    End point type
    Secondary
    End point timeframe
    At Day 0 (PRE) and Day 60 (D60) post-vaccination
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    27
    25
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        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)
    No statistical analyses for this end point

    Secondary: Number of subjects with any and grade 3 solicited local symptoms - Step 1

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    End point title
    Number of subjects with any and grade 3 solicited local symptoms - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    30
    30
    Units: Participants
        Any pain, PP [N=30, 30]
    2
    3
        Grade 3 pain, PP [N=30, 30]
    0
    1
        Any redness, PP [N=30, 30]
    0
    0
        Grade 3 redness, PP [N=30, 30]
    0
    0
        Any swelling, PP [N=30, 30]
    0
    0
        Grade 3 swelling, PP [N=30, 30]
    0
    0
        Any pain, D1 [N=28, 28]
    18
    7
        Grade 3 pain, D1 [N=28, 28]
    0
    0
        Any redness, D1 [N=28, 28]
    6
    1
        Grade 3 redness, D1 [N=28, 28]
    0
    0
        Any swelling, D1 [N=28, 28]
    4
    0
        Grade 3 swelling, D1 [N=28, 28]
    0
    0
        Any pain, D2 [N=27, 28]
    15
    6
        Grade 3 pain, D2 [N=27, 28]
    0
    1
        Any redness, D2 [N=27, 28]
    5
    0
        Grade 3 redness, D2 [N=27, 28]
    1
    0
        Any swelling, D2 [N=27, 28]
    1
    0
        Grade 3 swelling, D2 [N=27, 28]
    0
    0
        Any pain, Across Doses [N=28, 28]
    21
    8
        Grade 3 pain, Across Doses [N=28, 28]
    0
    1
        Any redness, Across Doses [N=28, 28]
    8
    1
        Grade 3 redness, Across Doses [N=28, 28]
    1
    0
        Any swelling, Across Doses [N=28, 28]
    4
    0
        Grade 3 swelling, Across Doses [N=28, 28]
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms - Step 1

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    End point title
    Number of subjects with any, grade 3 and related solicited general symptoms - Step 1
    End point description
    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
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    30
    30
    Units: Participants
        Any fatigue, PP [N=30, 30]
    8
    12
        Grade 3 fatigue, PP [N=30, 30]
    0
    1
        Related fatigue, PP [N=30, 30]
    2
    2
        Any gastrointestinal symptoms, PP [N=30, 30]
    8
    8
        Grade 3 gastrointestinal symptoms, PP [N=30, 30]
    0
    2
        Related gastrointestinal symptoms, PP [N=30, 30]
    1
    0
        Any headache, PP [N=30, 30]
    11
    13
        Grade 3 headache, PP [N=30, 30]
    0
    1
        Related headache, PP [N=30, 30]
    2
    2
        Any malaise, PP [N=30, 30]
    3
    4
        Grade 3 malaise, PP [N=30, 30]
    0
    0
        Related malaise, PP [N=30, 30]
    0
    1
        Any myalgia, PP [N=30, 30]
    2
    5
        Grade 3 myalgia, PP [N=30, 30]
    0
    1
        Related myalgia, PP [N=30, 30]
    1
    0
        Any shivering, PP [N=30, 30]
    4
    3
        Grade 3 shivering, PP [N=30, 30]
    0
    1
        Related shivering, PP [N=30, 30]
    0
    0
        Any temperature, PP [N=30, 30]
    1
    2
        Grade 3 temperature, PP [N=30, 30]
    0
    0
        Related temperature, PP [N=30, 30]
    0
    0
        Any Fatigue, D1 [N=28, 28]
    3
    6
        Grade 3 fatigue, D1 [N=28, 28]
    1
    0
        Related fatigue, D1 [N=28, 28]
    2
    6
        Any gastrointestinal symptoms, D1 [N=28, 28]
    4
    6
        Grade 3 gastrointestinal symptoms, D1 [N=28, 28]
    0
    1
        Related gastrointestinal symptoms, D1 [N=28, 28]
    4
    3
        Any headache, D1 [N=28, 28]
    14
    5
        Grade 3 headache, D1 [N=28, 28]
    0
    1
        Related headache, D1 [N=28, 28]
    11
    4
        Any malaise, D1 [N=28, 28]
    4
    2
        Grade 3 malaise, D1 [N=28, 28]
    0
    0
        Related malaise, D1 [N=28, 28]
    4
    2
        Any myalgia, D1 [N=28, 28]
    10
    1
        Grade 3 myalgia, D1 [N=28, 28]
    0
    0
        Related myalgia, D1 [N=28, 28]
    9
    1
        Any shivering, D1 [N=28, 28]
    2
    0
        Grade 3 shivering, D1 [N=28, 28]
    0
    0
        Related shivering, D1 [N=28, 28]
    2
    0
        Any temperature (≥37.5 °C), D1 [N=28, 28]
    2
    1
        Grade 3 temperature (> 39.5 °C), D1 [N=28, 28]
    0
    0
        Related temperature, D1 [N=28, 28]
    1
    0
        Any Fatigue, D2 [N=27, 28]
    10
    8
        Grade 3 fatigue, D2 [N=27, 28]
    1
    0
        Related fatigue, D2 [N=27, 28]
    10
    7
        Any gastrointestinal symptoms, D2 [N=27, 28]
    4
    5
        Grade 3 gastrointestinal symptoms, D2 [N=27, 28]
    0
    3
        Related gastrointestinal symptoms, D2 [N=27, 28]
    4
    5
        Any headache, D2 [N=27, 28]
    14
    5
        Grade 3 headache, D2 [N=27, 28]
    0
    1
        Related headache, D2 [N=27, 28]
    14
    5
        Any malaise, D2 [N=27, 28]
    7
    6
        Grade 3 malaise, D2 [N=27, 28]
    2
    1
        Related malaise, D2 [N=27, 28]
    7
    6
        Any myalgia, D2 [N=27, 28]
    10
    2
        Grade 3 myalgia, D2 [N=27, 28]
    0
    0
        Related myalgia, D2 [N=27, 28]
    10
    1
        Any shivering, D2 [N=27, 28]
    9
    2
        Grade 3 shivering, D2 [N=27, 28]
    0
    0
        Related shivering, D2 [N=27, 28]
    9
    2
        Any temperature (≥37.5 °C), D2 [N=27, 28]
    5
    1
        Grade 3 temperature (> 39.5 °C), D2 [N=27, 28]
    0
    0
        Related temperature, D2 [N=27, 28]
    4
    0
        Any Fatigue, Across Doses [N=28, 28]
    10
    9
        Grade 3 fatigue, Across Doses [N=28, 28]
    2
    0
        Related fatigue, Across Doses [N=28, 28]
    10
    9
        Any Gastro. sympt., Across Doses [N=28, 28]
    8
    8
        Grade 3 Gastro. sympt., Across Doses [N=28, 28]
    0
    4
        Related Gastro. sympt., Across Doses [N=28, 28]
    8
    7
        Any headache, Across Doses [N=28, 28]
    17
    6
        Grade 3 headache, Across Doses [N=28, 28]
    0
    1
        Related headache, Across Doses [N=28, 28]
    15
    6
        Any malaise, Across Doses [N=28, 28]
    8
    7
        Grade 3 malaise, Across Doses [N=28, 28]
    2
    1
        Related malaise, Across Doses [N=28, 28]
    8
    7
        Any myalgia, Across Doses [N=28, 28]
    14
    2
        Grade 3 myalgia, Across Doses [N=28, 28]
    0
    0
        Related myalgia, Across Doses [N=28, 28]
    13
    2
        Any shivering, Across Doses [N=28, 28]
    10
    2
        Grade 3 shivering, Across Doses [N=28, 28]
    0
    0
        Related shivering, Across Doses [N=28, 28]
    10
    2
        Any temperature, Across Doses [N=28, 28]
    6
    2
        Grade 3 temperature, Across Doses [N=28, 28]
    0
    0
        Related temperature, Across Doses [N=28, 28]
    4
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited symptoms, as assessed by the investigator/study nurse

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    End point title
    Number of subjects with solicited symptoms, as assessed by the investigator/study nurse
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Up to 4 days post-placebo/vaccine administration.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    30
    30
    Units: Participants
        Fever (≥37.5), placebo [N=30, 30]
    0
    0
        Fever (≥37.5), D1 [N=28, 30]
    2
    2
        Fever (≥37.5), D2 [N=27, 28]
    8
    0
        Pain, placebo [N=30, 30]
    1
    4
        Pain, D1 [N=28, 30]
    19
    9
        Pain, D2 [N=27, 28]
    19
    8
        Redness, placebo [N=30, 30]
    0
    0
        Redness, D1 [N=28, 30]
    8
    1
        Redness, D2 [N=27, 28]
    7
    0
        Induration, placebo [N=30, 30]
    0
    0
        Induration, D1 [N=28, 30]
    0
    0
        Induration, D2 [N=27, 28]
    1
    0
        Swelling, placebo [N=30, 30]
    0
    0
        Swelling, D1 [N=28, 30]
    3
    1
        Swelling, D2 [N=27, 28]
    4
    1
        Muscle stiffness, placebo [N=30, 30]
    0
    2
        Muscle stiffness, D1 [N=28, 30]
    14
    5
        Muscle stiffness, D2 [N=27, 28]
    15
    4
    No statistical analyses for this end point

    Secondary: Number of subjects with any unsolicited adverse events (AEs) - Step 1

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    End point title
    Number of subjects with any unsolicited adverse events (AEs) - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period.
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    30
    30
    Units: Participants
        Any AEs, post-placebo [N=30, 30]
    12
    16
        Any AEs, post-product administration [N=28, 29]
    14
    15
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs) - Step 1

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    End point title
    Number of subjects with serious adverse events (SAEs) - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    30
    30
    Units: Participants
        Day 60 SAEs [N=30;30]
    0
    0
        Day 210 SAEs [N=0;30]
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with any potential immune-mediated disorders (pIMDs) - Step 1

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    End point title
    Number of subjects with any potential immune-mediated disorders (pIMDs) - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    30
    30
    Units: Participants
        pIMDs - Day 60 [N=30;30]
    0
    0
        pIMDs - Day 210 [N=0;30]
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any new medical conditions requiring medical attention (MAEs) - Step 1

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    End point title
    Number of subjects with any new medical conditions requiring medical attention (MAEs) - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    30 [41]
    30
    Units: Participants
        MAEs - Day 60 [N=30;30]
    0
    0
        MAEs - Day 210 [N=0;30]
    0
    1
    Notes
    [41] - Step 1 completion for the HBsAg/AS_1 Group was reached at Day 60
    No statistical analyses for this end point

    Secondary: Levels of Alanine aminotransferase (ALT) in blood samples - Step 1

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    End point title
    Levels of Alanine aminotransferase (ALT) in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: U/L
    median (inter-quartile range (Q1-Q3))
        ALT, D1, Day 0 [N=28, 29]
    27.5 (22.5 to 32.5)
    27 (23 to 31)
        ALT, D1 (Day 0 H6) [N=28, 29]
    26.5 (22 to 33)
    26 (22 to 34)
        ALT, D1 (Day 0 H12) [N=28, 29]
    27 (23.5 to 31.5)
    26 (24 to 33)
        ALT, D1 (Day 0 H18) [N=15, 14]
    28 (25 to 35)
    24 (16 to 48)
        ALT, D1, Day 1 [N=28, 29]
    25.5 (20 to 33)
    27 (20 to 35)
        ALT, D1, Day 7 [N=28, 29]
    26.5 (22 to 32.5)
    28 (19 to 34)
        ALT, D2, Day 30 [N=27, 27]
    27 (22 to 36)
    30 (24 to 33)
        ALT, D2 (Day 30 H6) [N=27, 28]
    27 (23 to 34)
    28 (25 to 32)
        ALT, D2 (Day 30 H12) [N=27, 28]
    27 (24 to 34)
    28 (23 to 33.5)
        ALT, D2 (Day 30 H18) [N=14, 14]
    32 (25 to 37)
    26 (24 to 46)
        ALT, D2, Day 31 [N=27, 28]
    27 (22 to 33)
    27 (23 to 34)
        ALT, D2, Day 37 [N=27, 28]
    27 (22 to 30)
    26 (23.5 to 33)
        ALT, D2, Day 60 [N=27, 28]
    28 (23 to 32)
    28 (22.5 to 36)
    No statistical analyses for this end point

    Secondary: Levels of Aspartate aminotransferase (AST) in blood samples - Step 1

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    End point title
    Levels of Aspartate aminotransferase (AST) in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: U/L
    median (inter-quartile range (Q1-Q3))
        AST, D1, Day 0 [N=28, 29]
    21 (18 to 26)
    23 (18 to 25)
        AST, D1 (Day 0 H6) [N=28, 29]
    20.5 (18.5 to 24)
    21 (17 to 25)
        AST, D1 (Day 0 H12) [N=28, 29]
    20 (18.5 to 22.5)
    20 (17 to 25)
        AST, D1 (Day 0 H18) [N=15, 14]
    19 (15 to 24)
    18 (17 to 28)
        AST, D1, Day 1 [N=28, 29]
    19 (16 to 22.5)
    20 (18 to 23)
        AST, D1, Day 7 [N=28, 29]
    21 (18.5 to 25.5)
    21 (18 to 29)
        AST, D2, Day 30 [N=27, 27]
    21 (19 to 26)
    23 (19 to 25)
        AST, D2 (Day 30 H6) [N=27, 29]
    21 (19 to 24)
    22 (20 to 25.5)
        AST, D2 (Day 30 H12) [N=27, 29]
    20 (18 to 25)
    21 (20 to 24.5)
        AST, D2 (Day 30 H18) [N=14, 14]
    20 (19 to 22)
    19.5 (16 to 30)
        AST, D2, Day 31 [N=27, 28]
    19 (17 to 23)
    21 (18 to 25.5)
        AST, D2, Day 37 [N=27, 28]
    22 (19 to 25)
    23 (18 to 29.5)
        AST, D2, Day 60 [N=27, 28]
    21 (18 to 26)
    21.5 (18 to 28.5)
    No statistical analyses for this end point

    Secondary: Levels of Basophils in blood samples - Step 1

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    End point title
    Levels of Basophils in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: billion cells/L
    median (inter-quartile range (Q1-Q3))
        Basophils, D1, Day 0 [N=28, 29]
    0.03 (0.02 to 0.04)
    0.02 (0.02 to 0.03)
        Basophils, D1 (Day 0 H6) [N=28, 29]
    0.03 (0.02 to 0.04)
    0.03 (0.02 to 0.03)
        Basophils, D1 (Day 0 H12) [N=28, 29]
    0.03 (0.02 to 0.05)
    0.02 (0.02 to 0.03)
        Basophils, D1 (Day 0 H18) [N=15, 14]
    0.03 (0.01 to 0.03)
    0.02 (0.01 to 0.03)
        Basophils, D1, Day 1 [N=28, 29]
    0.03 (0.01 to 0.04)
    0.02 (0.02 to 0.03)
        Basophils, D1, Day 7 [N=28, 29]
    0.03 (0.02 to 0.04)
    0.03 (0.02 to 0.04)
        Basophils, D2, Day 30 [N=27, 27]
    0.03 (0.02 to 0.04)
    0.02 (0.02 to 0.04)
        Basophils, D2 (Day 30 H6) [N=27, 28]
    0.03 (0.02 to 0.04)
    0.02 (0.02 to 0.03)
        Basophils, D2 (Day 30 H12) [N=27, 28]
    0.02 (0.01 to 0.03)
    0.02 (0.02 to 0.04)
        Basophils, D2 (Day 30 H18) [N=14, 14]
    0.03 (0.01 to 0.03)
    0.02 (0.01 to 0.03)
        Basophils, D2, Day 31 [N=27, 28]
    0.02 (0.01 to 0.03)
    0.03 (0.02 to 0.04)
        Basophils, D2, Day 37 [N=27, 28]
    0.03 (0.02 to 0.06)
    0.03 (0.02 to 0.03)
        Basophils, D2, Day 60 [N=27, 28]
    0.03 (0.02 to 0.04)
    0.03 (0.02 to 0.03)
    No statistical analyses for this end point

    Secondary: Levels of total Bilirubin in blood samples - Step 1

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    End point title
    Levels of total Bilirubin in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        Total bilirubin, D1, Day 0 [N=28, 29]
    0.5 (0.4 to 0.7)
    0.5 (0.3 to 0.7)
        Total bilirubin, D1 (Day 0 H6) [N=28, 29]
    0.4 (0.25 to 0.5)
    0.4 (0.3 to 0.5)
        Total bilirubin, D1 (Day 0 H12) [N=28, 29]
    0.4 (0.3 to 0.6)
    0.3 (0.3 to 0.5)
        Total bilirubin, D1 (Day 0 H18) [N=15, 14]
    0.6 (0.4 to 0.8)
    0.5 (0.3 to 0.6)
        Total bilirubin, D1, Day 1 [N=28, 29]
    0.7 (0.6 to 0.9)
    0.5 (0.3 to 0.8)
        Total bilirubin, D1, Day 7 [N=28, 29]
    0.5 (0.4 to 0.7)
    0.5 (0.3 to 0.6)
        Total bilirubin, D2, Day 30 [N=27, 27]
    0.6 (0.4 to 0.7)
    0.5 (0.4 to 0.7)
        Total bilirubin, D2 (Day 30 H6) [N=27, 28]
    0.4 (0.3 to 0.5)
    0.4 (0.3 to 0.5)
        Total bilirubin, D2 (Day 30 H12) [N=27, 28]
    0.5 (0.4 to 0.6)
    0.4 (0.3 to 0.5)
        Total bilirubin, D2 (Day 30 H18) [N=14, 14]
    0.6 (0.4 to 0.7)
    0.45 (0.3 to 0.5)
        Total bilirubin, D2, Day 31 [N=27, 28]
    0.7 (0.5 to 1)
    0.5 (0.45 to 0.7)
        Total bilirubin, D2, Day 37 [N=27, 28]
    0.5 (0.3 to 0.8)
    0.5 (0.4 to 0.65)
        Total bilirubin, D2, Day 60 [N=27, 28]
    0.5 (0.4 to 0.6)
    0.5 (0.4 to 0.6)
    No statistical analyses for this end point

    Secondary: Levels of serum Creatinine in blood samples - Step 1

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    End point title
    Levels of serum Creatinine in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        Creatinine, D1, Day 0 [N=28, 29]
    0.8 (0.75 to 0.93)
    0.79 (0.72 to 0.85)
        Creatinine, D1 (Day 0 H6) [N=28, 29]
    0.75 (0.66 to 0.85)
    0.72 (0.69 to 0.82)
        Creatinine, D1 (Day 0 H12) [N=28, 29]
    0.78 (0.66 to 0.83)
    0.73 (0.68 to 0.83)
        Creatinine, D1 (Day 0 H18) [N=15, 14]
    0.7 (0.61 to 0.77)
    0.71 (0.63 to 0.84)
        Creatinine, D1, Day 1 [N=28, 29]
    0.74 (0.68 to 0.91)
    0.77 (0.71 to 0.85)
        Creatinine, D1, Day 7 [N=28, 29]
    0.81 (0.71 to 0.93)
    0.76 (0.69 to 0.87)
        Creatinine, D2, Day 30 [N=27, 27]
    0.82 (0.74 to 0.96)
    0.79 (0.72 to 0.83)
        Creatinine, D2 (Day 30 H6) [N=27, 28]
    0.75 (0.68 to 0.85)
    0.73 (0.67 to 0.83)
        Creatinine, D2 (Day 30 H12) [N=27, 28]
    0.76 (0.68 to 0.85)
    0.72 (0.69 to 0.82)
        Creatinine, D2 (Day 30 H18) [N=14, 14]
    0.74 (0.68 to 0.81)
    0.73 (0.65 to 0.82)
        Creatinine, D2, Day 31 [N=27, 28]
    0.79 (0.69 to 0.93)
    0.76 (0.7 to 0.87)
        Creatinine, D2, Day 37 [N=27, 28]
    0.81 (0.73 to 0.93)
    0.73 (0.7 to 0.9)
        Creatinine, D2, Day 60 [N=27, 28]
    0.84 (0.69 to 0.97)
    0.78 (0.72 to 0.91)
    No statistical analyses for this end point

    Secondary: Levels of Creatinine phosphokinase (CPK) in blood samples - Step 1

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    End point title
    Levels of Creatinine phosphokinase (CPK) in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        CPK, D1, Day 0 [N=28, 29]
    75 (56.5 to 108)
    80 (62 to 148)
        CPK, D1 (Day 0 H6 [N=28, 29]
    69.5 (53 to 106)
    75 (60 to 120)
        CPK, D1 (Day 0 H12) [N=28, 29]
    64.5 (51 to 94.5)
    77 (57 to 110)
        CPK, D1 (Day 0 H18) [N=15, 14]
    59 (49 to 90)
    61 (44 to 103)
        CPK, D1, Day 1 [N=28, 29]
    54 (42.5 to 79.5)
    69 (46 to 96)
        CPK, D1, Day 7 [N=28, 29]
    66 (55.5 to 95)
    80 (57 to 117)
        CPK, D2, Day 30 [N=27, 27]
    83 (48 to 122)
    87 (55 to 145)
        CPK, D2 (Day 30 H6) [N=27, 28]
    81 (45 to 108)
    86 (53.5 to 140.5)
        CPK, D2 (Day 30 H12) [N=27, 28]
    72 (50 to 98)
    80.5 (54 to 134)
        CPK, D2 (Day 30 H18) [N=14, 14]
    68.5 (53 to 103)
    70 (37 to 120)
        CPK, D2, Day 31 [N=27, 28]
    67 (44 to 87)
    75 (50 to 119)
        CPK, D2, Day 37 [N=27, 28]
    83 (59 to 119)
    93.5 (54 to 115.5)
        CPK, D2, Day 60 [N=27, 28]
    82 (55 to 118)
    82.5 (62 to 122)
    No statistical analyses for this end point

    Secondary: Levels of c-reactive protein (CRP) in blood samples - Step 1

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    End point title
    Levels of c-reactive protein (CRP) in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: mg/L
    median (inter-quartile range (Q1-Q3))
        CRP, D1, Day 0 [N=28, 29]
    1.15 (0.5 to 3)
    1.7 (0.5 to 2.5)
        CRP, D1 (Day 0 H6) [N=28, 29]
    0.8 (0.5 to 2.9)
    1.6 (0.5 to 2.4)
        CRP, D1 (Day 0 H12) [N=28, 29]
    1.5 (0.5 to 3.35)
    1.4 (0.5 to 2.1)
        CRP, D1 (Day 0 H18) [N=15, 14]
    2.9 (1.5 to 4.4)
    1.25 (0.5 to 1.8)
        CRP, D1, Day 1 [N=28, 29]
    5.8 (3.1 to 11.1)
    1.2 (0.5 to 1.8)
        CRP, D1, Day 7 [N=28, 29]
    1.9 (0.5 to 4.25)
    1.3 (0.5 to 2.6)
        CRP, D2, Day 30 [N=27, 27]
    1.3 (0.5 to 4.3)
    1.4 (0.5 to 3.1)
        CRP, D2 (Day 30 H6) [N=27, 28]
    1.2 (0.5 to 2.3)
    1.5 (0.5 to 3.05)
        CRP, D2 (Day 30 H12) [N=27, 28]
    1.8 (0.5 to 2.8)
    1.55 (0.5 to 3.1)
        CRP, D2 (Day 30 H18) [N=14, 14]
    3.15 (2.1 to 5.3)
    0.75 (0.5 to 2.8)
        CRP, D2, Day 31 [N=27, 28]
    5.8 (2.6 to 14.5)
    1.2 (0.5 to 2.65)
        CRP, D2, Day 37 [N=27, 28]
    2.1 (1.1 to 5.8)
    1.3 (0.5 to 2.95)
        CRP, D2, Day 60 [N=27, 28]
    1.4 (0.5 to 3.9)
    1.05 (0.5 to 3.85)
    No statistical analyses for this end point

    Secondary: Levels of Eosinophils in blood samples - Step 1

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    End point title
    Levels of Eosinophils in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: billion cells/L
    median (inter-quartile range (Q1-Q3))
        Eosinophils, D1, Day 0 [N=28, 29]
    0.2 (0.11 to 0.25)
    0.13 (0.1 to 0.21)
        Eosinophils, D1 (Day 0 H6) [N=28, 29]
    0.19 (0.13 to 0.27)
    0.13 (0.09 to 0.21)
        Eosinophils, D1 (Day 0 H12) [N=28, 29]
    0.21 (0.15 to 0.27)
    0.17 (0.12 to 0.21)
        Eosinophils, D1 (Day 0 H18) [N=15, 14]
    0.16 (0.12 to 0.3)
    0.2 (0.16 to 0.31)
        Eosinophils, D1, Day 1 [N=28, 29]
    0.15 (0.08 to 0.25)
    0.1 (0.07 to 0.2)
        Eosinophils, D1, Day 7 [N=28, 29]
    0.14 (0.08 to 0.2)
    0.11 (0.09 to 0.17)
        Eosinophils, D2, Day 30 [N=27, 27]
    0.18 (0.11 to 0.25)
    0.14 (0.09 to 0.26)
        Eosinophils, D2 (Day 30 H6) [N=27, 28]
    0.18 (0.1 to 0.29)
    0.13 (0.09 to 0.22)
        Eosinophils, D2 (Day 30 H12) [N=27, 28]
    0.19 (0.12 to 0.31)
    0.14 (0.09 to 0.24)
        Eosinophils, D2 (Day 30 H18) [N=14, 14]
    0.14 (0.05 to 0.21)
    0.19 (0.12 to 0.32)
        Eosinophils, D2, Day 31 [N=27, 28]
    0.14 (0.05 to 0.2)
    0.13 (0.09 to 0.22)
        Eosinophils, D2, Day 37 [N=27, 28]
    0.19 (0.11 to 0.24)
    0.15 (0.09 to 0.23)
        Eosinophils, D2, Day 60 [N=27, 28]
    0.19 (0.1 to 0.28)
    0.14 (0.11 to 0.24)
    No statistical analyses for this end point

    Secondary: Levels of Haemoglobin in blood samples - Step 1

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    End point title
    Levels of Haemoglobin in blood samples - Step 1
    End point description
    Haematological laboratory parameters assessed included haemoglobin levels, expressed in gram per deciliter (d/dL). Haemoglobin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: g/dL
    median (inter-quartile range (Q1-Q3))
        Haemoglobin, D1, Day 0 [N=28, 29]
    13.35 (12.7 to 14.5)
    13.8 (12.5 to 14.8)
        Haemoglobin, D1 (Day 0 H6) [N=28, 29]
    13.45 (12.3 to 14.05)
    13.6 (12.5 to 14.6)
        Haemoglobin, D1 (Day 0 H12) [N=28, 29]
    13.25 (12.3 to 14.3)
    13.2 (12.6 to 14.5)
        Haemoglobin, D1 (Day 0 H18) [N=15, 14]
    12.6 (12 to 13.9)
    13.15 (12.5 to 14.5)
        Haemoglobin, D1, Day 1 [N=28, 29]
    13.5 (12.6 to 14.45)
    13.8 (12.9 to 14.7)
        Haemoglobin, D1, Day 7 [N=28, 29]
    13.35 (12.55 to 14.35)
    13.8 (12.8 to 14.6)
        Haemoglobin, D2, Day 30 [N=27, 27]
    13.7 (12.7 to 14.3)
    13.4 (12.6 to 14.3)
        Haemoglobin, D2 (Day 30 H6) [N=27, 28]
    13.4 (12.5 to 14)
    13.55 (12.45 to 14.15)
        Haemoglobin, D2 (Day 30 H12) [N=27, 28]
    13.2 (12.6 to 14.1)
    13.1 (12.4 to 14.15)
        Haemoglobin, D2 (Day 30 H18) [N=14, 14]
    13.15 (11.7 to 13.9)
    13.05 (12.3 to 14.1)
        Haemoglobin, D2, Day 31 [N=27, 28]
    13.5 (12.5 to 14.4)
    13.75 (12.65 to 14.6)
        Haemoglobin, D2, Day 37 [N=27, 28]
    13.6 (12.6 to 14.5)
    13.65 (12.35 to 14.5)
        Haemoglobin, D2, Day 60 [N=27, 28]
    13.5 (12.4 to 14.5)
    13.8 (12.2 to 14.5)
    No statistical analyses for this end point

    Secondary: Levels of Lactate dehydrogenase (LDH) in blood samples - Step 1

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    End point title
    Levels of Lactate dehydrogenase (LDH) in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: U/L
    median (inter-quartile range (Q1-Q3))
        LDH, D1, Day 0 [N=28, 29]
    401.5 (377 to 473.5)
    382 (346 to 438)
        LDH, D1 (Day 0 H6) [N=28, 29]
    414 (388.5 to 449.5)
    389 (353 to 423)
        LDH, D1 (Day 0 H12) [N=28, 29]
    412 (392 to 457.5)
    378 (339 to 426)
        LDH, D1 (Day 0 H18) [N=15, 14]
    422 (341 to 461)
    369.5 (302 to 410)
        LDH, D1, Day 1 [N=28, 29]
    389 (352 to 466)
    367 (342 to 411)
        LDH, D1, Day 7 [N=28, 29]
    417.5 (382.5 to 479.5)
    392 (371 to 436)
        LDH, D2, Day 30 [N=27, 27]
    391 (360 to 456)
    395 (348 to 426)
        LDH, D2 (Day 30 H6) [N=27, 28]
    437 (397 to 470)
    396.5 (350.5 to 428)
        LDH, D2 (Day 30 H12) [N=27, 28]
    425 (403 to 470)
    382.5 (338.5 to 424)
        LDH, D2 (Day 30 H18) [N=14, 14]
    403 (365 to 450)
    334.5 (297 to 390)
        LDH, D2, Day 31 [N=27, 28]
    408 (373 to 453)
    372 (354 to 403)
        LDH, D2, Day 37 [N=27, 28]
    442 (412 to 464)
    403 (368.5 to 446)
        LDH, D2, Day 60 [N=27, 28]
    422 (397 to 478)
    404 (374 to 431.5)
    No statistical analyses for this end point

    Secondary: Levels of Lymphocytes in blood samples - Step 1

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    End point title
    Levels of Lymphocytes in blood samples - Step 1
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    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
    End point values
    hbsag/as_1 group engerix-b_1 group
    Number of subjects analysed
    28
    29
    Units: billion cells/L
    median (inter-quartile range (Q1-Q3))
        Lymphocytes, D1, Day 0 [N=28, 29]
    1.84 (1.45 to 1.98)
    1.99 (1.61 to 2.26)
        Lymphocytes, D1 (Day 0 H6) [N=28, 29]
    1.89 (1.48 to 2.35)
    2.07 (1.52 to 2.46)
        Lymphocytes, D1 (Day 0 H12) [N=28, 29]
    1.97 (1.72 to 2.33)
    2.39 (2 to 2.97)
        Lymphocytes, D1 (Day 0 H18) [N=15, 14]
    1.73 (1.41 to 2.48)
    3.08 (2.45 to 3.53)
        Lymphocytes, D1, Day 1 [N=28, 29]
    1.58 (1.25 to 1.83)
    1.94 (1.66 to 2.26)
        Lymphocytes, D1, Day 7 [N=28, 29]
    1.69 (1.37 to 1.91)
    1.97 (1.56 to 2.17)
        Lymphocytes, D2, Day 30 [N=27, 27]
    1.67 (1.36 to 2.03)
    1.97 (1.64 to 2.5)
        Lymphocytes, D2 (Day 30 H6 [N=27, 28]
    1.81 (1.56 to 2.16)
    2.11 (1.78 to 2.59)
        Lymphocytes, D2 (Day 30 H12) [N=27, 28]
    1.9 (1.36 to 2.39)
    2.35 (2.1 to 2.82)
        Lymphocytes, D2 (Day 30 H18) [N=14, 14]
    1.46 (1.06 to 1.83)
    2.99 (2.45 to 3.53)
        Lymphocytes, D2, Day 31 [N=27, 28]
    1.19 (0.89 to 1.43)
    2.01 (1.75 to 2.5)
        Lymphocytes, D2, Day 37 [N=27, 28]
    1.74 (1.41 to 2.21)
    2.01 (1.64 to 2.36)
        Lymphocytes, D2, Day 60 [N=27, 28]
    1.76 (1.4 to 2.29)
    2.09 (1.73 to 2.31)
    No statistical analyses for this end point

    Secondary: Levels of Monocytes in blood samples - Step 1

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