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    Clinical Trial Results:
    Immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-Hepatitis B vaccine (10 µg) in newborns of Hepa-titis B envelope antigen positive (HBeAg+) and Hepatitis B surface antigen positive (HBsAg+) mothers compared with a historical control group.

    Summary
    EudraCT number
    		 2011-002629-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Jul 2008

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

    Trial information

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    Trial identification
    Sponsor protocol code
    100449
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00240539
    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
    25 Jul 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jul 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the anti-HBs antibody persistence from Year 16 up to Y 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) upto 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
    Vaccines/products were administered by qualified and trained personnel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 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: 36
    Worldwide total number of subjects
    36
    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)
    14
    Adults (18-64 years)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overall study (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
    		 HBsAg(+) & HBeAg(+) 5-dose Group
    Arm description
    		 Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™-B Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Four (HBsAg(+) & HBeAg(-) 4-dose Group, HBsAg(+) & HBeAg(+) 4-dose Group and HBsAg(-) & HBeAg(-) 4-dose Group) and five (HBsAg(+) & HBeAg(+) 5-dose Group) doses administered intramuscularly

    Arm title
    		 HBsAg(+) & HBeAg(-) 4-dose Group
    Arm description
    		 Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™-B Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Four (HBsAg(+) & HBeAg(-) 4-dose Group, HBsAg(+) & HBeAg(+) 4-dose Group and HBsAg(-) & HBeAg(-) 4-dose Group) and five (HBsAg(+) & HBeAg(+) 5-dose Group) doses administered intramuscularly

    Arm title
    		 HBsAg(-) & HBeAg(-) 4-dose Group
    Arm description
    		 Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™-B Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Four (HBsAg(+) & HBeAg(-) 4-dose Group, HBsAg(+) & HBeAg(+) 4-dose Group and HBsAg(-) & HBeAg(-) 4-dose Group) and five (HBsAg(+) & HBeAg(+) 5-dose Group) doses administered intramuscularly

    Arm title
    		 HBsAg(+) & HBeAg(+) 4-dose Group
    Arm description
    		 Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™-B Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Four (HBsAg(+) & HBeAg(-) 4-dose Group, HBsAg(+) & HBeAg(+) 4-dose Group and HBsAg(-) & HBeAg(-) 4-dose Group) and five (HBsAg(+) & HBeAg(+) 5-dose Group) doses administered intramuscularly

    Number of subjects in period 1
    		HBsAg(+) & HBeAg(+) 5-dose Group HBsAg(+) & HBeAg(-) 4-dose Group HBsAg(-) & HBeAg(-) 4-dose Group HBsAg(+) & HBeAg(+) 4-dose Group
    Started
    2
    2
    1
    31
    Completed
    2
    2
    1
    31

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HBsAg(+) & HBeAg(+) 5-dose Group
    Reporting group description
    		 Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.

    Reporting group title
    HBsAg(+) & HBeAg(-) 4-dose Group
    Reporting group description
    		 Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.

    Reporting group title
    HBsAg(-) & HBeAg(-) 4-dose Group
    Reporting group description
    		 Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.

    Reporting group title
    HBsAg(+) & HBeAg(+) 4-dose Group
    Reporting group description
    		 Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.

    Reporting group values
    		 HBsAg(+) & HBeAg(+) 5-dose Group HBsAg(+) & HBeAg(-) 4-dose Group HBsAg(-) & HBeAg(-) 4-dose Group HBsAg(+) & HBeAg(+) 4-dose Group Total
    Number of subjects
    		 2 2 1 31 36
    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)
    		 20 ( 0 ) 19.5 ( 0.51 ) 20 ( 0 ) 19.5 ( 0.71 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2 1 18 23
        Male
    		 0 0 0 13 13

    End points

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    End points reporting groups
    Reporting group title
    HBsAg(+) & HBeAg(+) 5-dose Group
    Reporting group description
    		 Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.

    Reporting group title
    HBsAg(+) & HBeAg(-) 4-dose Group
    Reporting group description
    		 Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.

    Reporting group title
    HBsAg(-) & HBeAg(-) 4-dose Group
    Reporting group description
    		 Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.

    Reporting group title
    HBsAg(+) & HBeAg(+) 4-dose Group
    Reporting group description
    		 Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.

    Primary: Number of subjects seropositive for anti-hepatitis B surface antigen (anti-HBs) antibodies

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    End point title
    		 Number of subjects seropositive for anti-hepatitis B surface antigen (anti-HBs) antibodies [1] [2]
    End point description
    Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL. This outcome measure applies to HBsAg(+) & HBeAg(+) 5-dose and HBsAg(+) & HBeAg(+) 4-dose Groups only.
    End point type
    Primary
    End point timeframe
    At Years 16, 17, 18, 19 and 20 after primary vaccination
    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.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to HBsAg(+) & HBeAg(+) 5-dose and HBsAg(+) & HBeAg(+) 4-dose Groups only.
    End point values
    		 HBsAg(+) & HBeAg(+) 5-dose Group HBsAg(+) & HBeAg(+) 4-dose Group
    Number of subjects analysed
    2
    25
    Units: Subjects
        Year 16 (n= 0, 25)
    0
    22
        Year 17 (n= 2, 24)
    2
    21
        Year 18 (n= 1, 22)
    1
    20
        Year 19 (n= 2, 22)
    2
    19
        Year 20 (n= 2, 25)
    2
    23
    No statistical analyses for this end point

    Primary: Number of subjects who tested positive for markers of infection with hepatitis B virus

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    End point title
    		 Number of subjects who tested positive for markers of infection with hepatitis B virus [3] [4]
    End point description
    Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe). This outcome measure applies to HBsAg(+) & HBeAg(+) 5-dose and HBsAg(+) & HBeAg(+) 4-dose Groups only.
    End point type
    Primary
    End point timeframe
    At Years 16, 17, 18, 19 and 20 after primary vaccination
    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
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure applies to HBsAg(+) & HBeAg(+) 5-dose and HBsAg(+) & HBeAg(+) 4-dose Groups only.
    End point values
    		 HBsAg(+) & HBeAg(+) 5-dose Group HBsAg(+) & HBeAg(+) 4-dose Group
    Number of subjects analysed
    2
    25
    Units: Subjects
        HBsAg [Year 16] (n= 1, 25)
    0
    0
        HBsAg [Year 17] (n= 2, 25)
    0
    1
        HBsAg [Year 18] (n= 1, 22)
    0
    0
        HBsAg [Year 19] (n= 1, 22)
    0
    2
        HBsAg [Year 20] (n= 2, 25)
    0
    2
        Anti-HBc [Year 16] (n= 1, 25)
    1
    4
        Anti-HBc [Year 17] (n= 2, 25)
    1
    3
        Anti-HBc [Year 18] (n= 1, 22)
    1
    2
        Anti-HBc [Year 19] (n= 2, 22)
    1
    2
        Anti-HBc [Year 20] (n= 2, 25)
    1
    3
        HBeAg [Year 16] (n= 1, 23)
    0
    0
        HBeAg [Year 17] (n= 1, 3)
    0
    0
        HBeAg [Year 18] (n= 1, 2)
    0
    0
        HBeAg [Year 19] (n= 1, 4)
    0
    0
        HBeAg [Year 20] (n= 1, 5)
    0
    0
        Anti-HBe [Year 16] (n= 1, 23)
    1
    0
        Anti-HBe [Year 17] (n= 1, 4)
    1
    1
        Anti-HBe [Year 18] (n= 1, 2)
    1
    0
        Anti-HBe [Year 19] (n= 1, 4)
    0
    0
        Anti-HBe [Year 20] (n= 1, 5)
    1
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Chronic and With Clinical HBV Infection

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    End point title
    		 Number of Subjects With Chronic and With Clinical HBV Infection [5]
    End point description
    Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points. Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point.
    End point type
    Primary
    End point timeframe
    From year 16 through to year 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
    		 HBsAg(+) & HBeAg(+) 5-dose Group HBsAg(+) & HBeAg(-) 4-dose Group HBsAg(-) & HBeAg(-) 4-dose Group HBsAg(+) & HBeAg(+) 4-dose Group
    Number of subjects analysed
    2
    2
    1
    31
    Units: Subjects
        Chronic HBV infection
    0
    0
    0
    1
        Clinical HBV infection
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No analysis of safety was performed during this long-term follow-up study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not Applicable
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: No analysis of safety was performed during this long-term follow-up study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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