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    Clinical Trial Results:
    Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-DNA Hepatitis B vaccine (10µg) with or without Hepatitis B immunoglobulin (HBIG) in newborns of Hepatitis B envelope antigen positive (HBeAg+) mothers

    Summary
    EudraCT number
    		 2011-004879-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Mar 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Apr 2016
    First version publication date
    22 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    100450
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00240526
    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, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Nov 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Mar 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the anti-HBs persistence up to Year 20 after the first vaccine dose of the primary vaccination. • To evaluate the prevalence and incidence of other hepatitis B markers (HBsAg, anti-HBc, HBeAg, anti-HBe) up to Year 20 after the first vaccine dose of the primary vaccination. • To evaluate the clinical significance of the HBsAg positive and anti-HBc positive cases observed during the long-term follow-up of this study.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for one month (minimum 30 days) following administration of the last dose of study vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Oct 2003
    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
    Thailand: 79
    Worldwide total number of subjects
    79
    EEA total number of subjects
    0
    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)
    30
    Adults (18-64 years)
    49
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The baseline characteristics are given for the Year 15 time point. Therefore the number of participants in the Engerix-3D Group is 21, as in the Year 15 participant flow data.

    Period 1
    Period 1 title
    At Year 15 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Engerix 4D + HBIg Group
    Arm description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™ -B
    Investigational medicinal product code
    Other name
    HBV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study.

    Investigational medicinal product name
    Hepatitis B immunoglobulin (HBIg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 intramuscular injections at birth (primary study).

    Arm title
    		 Engerix 3D + HBIg Group
    Arm description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™ -B
    Investigational medicinal product code
    Other name
    HBV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study.

    Investigational medicinal product name
    Hepatitis B immunoglobulin (HBIg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 intramuscular injections at birth (primary study).

    Arm title
    		 Engerix 4D
    Arm description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™ -B
    Investigational medicinal product code
    Other name
    HBV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study.

    Arm title
    		 Engerix 3D Group
    Arm description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™ -B
    Investigational medicinal product code
    Other name
    HBV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study.

    Number of subjects in period 1 [1]
    		Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group
    Started
    19
    19
    14
    21
    Completed
    19
    19
    14
    21
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The baseline characteristics are given for subjects who came back at Year 15 time-point of the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Engerix 4D + HBIg Group
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

    Reporting group title
    Engerix 3D + HBIg Group
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

    Reporting group title
    Engerix 4D
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.

    Reporting group title
    Engerix 3D Group
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6.

    Reporting group values
    		 Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group Total
    Number of subjects
    		 19 19 14 21 73
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.5 ± 0.51 14.7 ± 0.45 14.6 ± 0.5 14.5 ± 0.51 -
    Gender categorical
    Units: Subjects
        Female
    		 12 7 6 10 35
        Male
    		 7 12 8 11 38

    End points

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    End points reporting groups
    Reporting group title
    Engerix 4D + HBIg Group
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

    Reporting group title
    Engerix 3D + HBIg Group
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

    Reporting group title
    Engerix 4D
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.

    Reporting group title
    Engerix 3D Group
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6.

    Primary: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as measured by Enzyme-Linked Immunosorbent Assay (ELISA).

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    End point title
    		 Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as measured by Enzyme-Linked Immunosorbent Assay (ELISA). [1]
    End point description
    Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL.
    End point type
    Primary
    End point timeframe
    At Years 15, 16, 17, 18, 19 and 20
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group
    Number of subjects analysed
    17
    15
    12
    17
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Year 15 (N=17;15;12;17)
    118.6 (53.4 to 263.1)
    14.8 (6.8 to 32)
    142.8 (30.4 to 669.4)
    24.2 (10 to 58.7)
        Year 16 (N=15;13;12;16)
    119.3 (50 to 284.7)
    14.1 (6.8 to 29.4)
    134.3 (30.1 to 599.8)
    22.9 (9.7 to 54.1)
        Year 17 (N=17;13;11;13)
    140 (67.2 to 291.9)
    8.2 (3.9 to 17.1)
    70.2 (14.3 to 344.1)
    17 (6.7 to 43.3)
        Year 18 (N=14;14;10;13)
    82.3 (32.1 to 211.3)
    10.8 (6.5 to 17.9)
    56.5 (11.7 to 271.8)
    26.1 (10.7 to 63.3)
        Year 19 (N=13;12;8;11)
    103.3 (38.9 to 274.7)
    9.5 (4 to 22.8)
    84.9 (12 to 600.2)
    19.9 (7.4 to 53.7)
        Year 20 (N=13;13;6;12)
    73.9 (26.6 to 205.4)
    14.3 (6.7 to 30.6)
    297.1 (46 to 1919.5)
    16.3 (7.2 to 36.9)
    No statistical analyses for this end point

    Primary: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as measured by ChemiLuminescence ImmunoAssay (CLIA).

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    End point title
    		 Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as measured by ChemiLuminescence ImmunoAssay (CLIA). [2]
    End point description
    Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: There was a change of assay kit at Year 19 time-point, thus for the sake of bridging, blood samples corresponding to Year 19 were re-tested with new CLIA. At Year 19 and 20, anti-HBs antibody concentrations tested with the CLIA with cut-off 6.2 mIU/mL.
    End point type
    Primary
    End point timeframe
    At Years 19 and 20
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group
    Number of subjects analysed
    16
    13
    7
    13
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        YEAR 19 (N=14;12;6;11)
    60.1 (26.7 to 135.5)
    5.8 (3.3 to 10)
    159 (32.6 to 776.5)
    11.7 (5 to 27.4)
        YEAR 20 (N=16;13;7;13)
    44 (18.3 to 105.9)
    5.1 (3.1 to 8.6)
    83.5 (16.2 to 431.7)
    9.5 (4.3 to 21.2)
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-hepatitis B surface antigen (anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).

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    End point title
    		 Number of Subjects With Anti-hepatitis B surface antigen (anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). [3]
    End point description
    Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.
    End point type
    Primary
    End point timeframe
    At Years 15, 16, 17, 18, 19 and 20
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group
    Number of subjects analysed
    17
    15
    12
    17
    Units: Subjects
        Year 15 (≥ 1.0 mIU/mL) (N=17;15;12;17)
    17
    7
    10
    11
        Year 15 (≥ 10 mIU/mL) (N=17;15;12;17)
    16
    4
    9
    7
        Year 16 (≥ 1.0 mIU/mL) (N=15;13;12;16)
    15
    9
    12
    11
        Year 16 (≥ 10 mIU/mL) (N=15;13;12;16)
    14
    6
    10
    8
        Year 17 (≥ 1.0 mIU/mL) (N=17;13;11;13)
    15
    7
    11
    10
        Year 17 (≥ 10 mIU/mL) (N=17;13;11;13)
    15
    2
    9
    5
        Year 18 (≥ 1.0 mIU/mL) (N=14;14;10;13)
    14
    7
    10
    8
        Year 18 (≥ 10 mIU/mL) (N=14;14;10;13)
    13
    3
    7
    7
        Year 19 (≥ 1.0 mIU/mL) (N=14;12;8;11)
    13
    7
    8
    8
        Year 19 (≥ 10 mIU/mL) (N=14;12;8;11)
    12
    3
    6
    6
        Year 20 (≥ 1.0 mIU/mL) (N=13;13;6;12)
    13
    9
    5
    10
        Year 20 (≥ 10 mIU/mL) (N=13;13;6;12)
    11
    5
    5
    6
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-hepatitis B surface antigen (anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as measured by ChemiLuminescence ImmunoAssay (CLIA)

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    End point title
    		 Number of Subjects With Anti-hepatitis B surface antigen (anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as measured by ChemiLuminescence ImmunoAssay (CLIA) [4]
    End point description
    Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.
    End point type
    Primary
    End point timeframe
    At Years 19 and 20
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group
    Number of subjects analysed
    16
    13
    7
    13
    Units: Subjects
    number (not applicable)
        Year 19 (≥ 1.0 mIU/mL) (N=14;12;6;11)
    13
    4.2
    6
    7
        Year 19 (≥ 10 mIU/mL) (N=14;12;6;11)
    12
    3.9
    5
    4
        Year 20 (≥ 1.0 mIU/mL) (N=16;13;7;13)
    13.1
    5.4
    6
    6.3
        Year 20 (≥ 10 mIU/mL) (N=16;13;7;13)
    12.2
    2.1
    5
    5.8
    No statistical analyses for this end point

    Primary: Number of subjects with positive results for serological markers for hepatitis B infection

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    End point title
    		 Number of subjects with positive results for serological markers for hepatitis B infection [5]
    End point description
    Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe).
    End point type
    Primary
    End point timeframe
    At Years 15, 16, 17, 18, 19 and 20
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group
    Number of subjects analysed
    19
    19
    14
    21
    Units: Subjects
        Year 15 HBsAg (N=19;19;14;21)
    0
    1
    0
    3
        Year 15 Anti-HBc (N=19;19;14;21)
    4
    7
    1
    9
        Year 15 HBeAg (N=4;7;1;8)
    0
    1
    0
    1
        Year 15 Anti-HBe (N=4;7;1;8)
    1
    1
    0
    3
        Year 16 HBsAg (N=16;17;16;22)
    2
    0
    2
    5
        Year 16 Anti-HBc (N=16;17;16;22)
    4
    5
    1
    9
        Year 16 HBeAg (N=6;5;3;11)
    1
    1
    0
    3
        Year 16 Anti-HBe (N=6;5;3;11)
    0
    1
    0
    2
        Year 17 HBsAg (N=19;17;13;19)
    6
    0
    3
    6
        Year 17 Anti-HBc (N=19;17;13;20)
    5
    5
    1
    8
        Year 17 HBeAg (N=9;5;4;10)
    0
    0
    0
    1
        Year 17 Anti-HBe (N=9;5;4;10)
    1
    0
    0
    3
        Year 18 HBsAg (N=16;17;14;20)
    3
    1
    3
    5
        Year 18 Anti-HBc (N=16;17;14;20)
    5
    6
    1
    8
        Year 18 HBeAg (N=8;7;4;10)
    0
    0
    0
    1
        Year 18 Anti-HBe (N=8;7;4;10)
    1
    1
    0
    2
        Year 19 HBsAg (N=17;16;12;18)
    4
    3
    3
    5
        Year 19 Anti-HBc (N=17;16;12;18)
    4
    5
    2
    9
        Year 19 HBeAg (N=8;7;5;10)
    0
    0
    0
    2
        Year 19 Anti-HBe (N=8;7;5;10)
    1
    1
    0
    3
        Year 20 HBsAg (N=19;17;12;20)
    6
    5
    4
    12
        Year 20 Anti-HBc (N=19;17;12;20)
    5
    7
    2
    8
        Year 20 HBeAg (N=8;7;6;14)
    1
    0
    0
    1
        Year 20 Anti-HBe (N=10;9;6;15)
    1
    0
    0
    3
    No statistical analyses for this end point

    Primary: Number of subjects with different hepatitis B infection statuses

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    End point title
    		 Number of subjects with different hepatitis B infection statuses [6]
    End point description
    Categories hepatitis B (HB) infection: 1) Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples 2) False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg. 3) Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples. 4) Isolated natural booster: >4-fold increase of anti-HBs concentrations if <100 mIU/mL at previous sample OR >2- fold increase of anti-HBs concentrations if >=100 mIU/mL at previous sample + other markers neg
    End point type
    Primary
    End point timeframe
    Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group
    Number of subjects analysed
    19
    19
    14
    21
    Units: Subjects
        Chronic HB infection
    0
    0
    0
    4
        False positive
    5
    5
    9
    10
        Possible subclinical breakthrough HB infection
    9
    12
    4
    10
        Isolated natural booster
    8
    8
    9
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No SAEs were reported from Year 15 to Year 20.
    Adverse event reporting additional description
    As no adverse events data were collected during this study the number of participants at risk is 0 for all groups.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Engerix 4D + HBIg Group
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

    Reporting group title
    Engerix 3D + HBIg Group
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

    Reporting group title
    Engerix 4D
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.

    Reporting group title
    Engerix 3D Group
    Reporting group description
    		 Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6.

    Serious adverse events
    		 Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Engerix 4D + HBIg Group Engerix 3D + HBIg Group Engerix 4D Engerix 3D Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 14 (0.00%)
    0 / 21 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: As no adverse events data were collected during this study the number of participants at risk is 0 for all groups.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Aug 2003
    The protocol was amended to further extend the follow-up period up to Year 20 after the first vaccine dose (with a blood sample taken at yearly intervals), to evaluate the anti-HBs persistence and to further investigate the prevalence and incidence of other hepatitis B markers (HBsAg, anti-HBc, HBeAg, anti-HBe, ALT/AST), and the clinical significance of the HBsAg and anti-HBc positive cases observed during the long-term follow-up of this study. These additional data was important to determine the long-term booster policy in subjects born from HBsAg+ mothers. Moreover, if subjects developed clinical signs possibly related to hepatitis B or have significantly high AST/ALT serum concentrations, additional medical tests were performed by the investigator, according to good medical practices.
    05 Apr 2007
    The protocol was amended to state that from Year 16 onwards to Year 20 time points, only subjects who test positive for HBsAg or anti-HBc antibodies were tested for HBeAg and anti-HBe antibodies.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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