Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36367   clinical trials with a EudraCT protocol, of which   5991   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An open, phase IV, single-group, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B (HBV) vaccine challenge in children aged 7-8 years of age and previously vaccinated in infancy with GSK Biologicals’ HBV vaccine (Engerix™-B).

    Summary
    EudraCT number
    2007-002221-76
    Trial protocol
    DE  
    Global end of trial date
    31 Dec 2007

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    04 Dec 2014
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    110474
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00519649
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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
    31 Dec 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the anti-HBs antibody response to a challenge dose of HBV vaccine (Engerix-B Kinder) in subjects, 7-8 years of age, previously vaccinated with three doses of Engerix-B in infancy.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    31 Aug 2007
    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
    Germany: 301
    Worldwide total number of subjects
    301
    EEA total number of subjects
    301
    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)
    301
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    One additional subject, enrolled but not vaccinated, was not included in the number of subjects under "STARTED"

    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
    Arm title
    Group Engerix
    Arm description
    Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
    Arm type
    Experimental

    Investigational medicinal product name
    Engerix™-B Kinder
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)

    Number of subjects in period 1 [1]
    Group Engerix
    Started
    300
    Completed
    299
    Not completed
    1
         Consent withdrawn by subject
    1
    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: One additional subject, enrolled but not vaccinated, was not included in the number of subjects under "STARTED"

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    -

    Reporting group values
    Overall Study Total
    Number of subjects
    300 300
    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
        geometric mean (standard deviation)
    7.7 ± 0.46 -
    Gender categorical
    Units: Subjects
        Female
    136 136
        Male
    164 164

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Group Engerix
    Reporting group description
    Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)

    Primary: Number of participants with anti-hepatitis B surface antigen (HBs) antibody concentrations above the cut-off value

    Close Top of page
    End point title
    Number of participants with anti-hepatitis B surface antigen (HBs) antibody concentrations above the cut-off value [1]
    End point description
    Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)
    End point type
    Primary
    End point timeframe
    One month after the challenge dose of HBV vaccine
    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
    Group Engerix
    Number of subjects analysed
    280
    Units: Subjects
        anti-(HB)s
    275
    No statistical analyses for this end point

    Secondary: Number of participants with Anti-HBs antibody concentrations above the cut-off value

    Close Top of page
    End point title
    Number of participants with Anti-HBs antibody concentrations above the cut-off value
    End point description
    Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL
    End point type
    Secondary
    End point timeframe
    Before challenge dose of HBV vaccine
    End point values
    Group Engerix
    Number of subjects analysed
    282
    Units: Subjects
        >= 3.3 mIU/mL
    261
        >= 10 mIU/mL
    235
        >= 100 mIU/mL
    104
    No statistical analyses for this end point

    Secondary: Number of Participants reporting Solicited Local Symptoms

    Close Top of page
    End point title
    Number of Participants reporting Solicited Local Symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period after the challenge dose of HBV vaccine.
    End point values
    Group Engerix
    Number of subjects analysed
    299
    Units: Subjects
        Pain
    89
        Redness
    81
        Swelling
    42
    No statistical analyses for this end point

    Secondary: Number of Participants reporting Solicited General Symptoms

    Close Top of page
    End point title
    Number of Participants reporting Solicited General Symptoms
    End point description
    Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache
    End point type
    Secondary
    End point timeframe
    During the 4-day follow-up period after the challenge dose of HBV vaccine.
    End point values
    Group Engerix
    Number of subjects analysed
    299
    Units: Subjects
        Fatigue
    44
        Fever (Axillary)
    9
        Gastrointestinal
    23
        Headache
    40
    No statistical analyses for this end point

    Secondary: Number of Participants reporting Unsolicited adverse events

    Close Top of page
    End point title
    Number of Participants reporting Unsolicited adverse events
    End point description
    An Adverse Event is 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.
    End point type
    Secondary
    End point timeframe
    During the 31-day follow-up period after the challenge dose of HBV vaccine.
    End point values
    Group Engerix
    Number of subjects analysed
    300
    Units: Subjects
        Unsolicited adverse events
    71
    No statistical analyses for this end point

    Secondary: Number of Participants reporting serious adverse events (SAE)

    Close Top of page
    End point title
    Number of Participants reporting serious adverse events (SAE)
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    After the challenge dose of HBV vaccine.
    End point values
    Group Engerix
    Number of subjects analysed
    300
    Units: Subjects
        (SAE)
    1
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse events and Unsolicited Adverse events: During the 31-day follow-up period after HBV challenge dose. Solicited local and general symptoms: During the 4-day follow-up period after the HBV challenge dose.
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Group Engerix
    Reporting group description
    Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)

    Serious adverse events
    Group Engerix
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 300 (0.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group Engerix
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    89 / 300 (29.67%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    89 / 299 (29.77%)
         occurrences all number
    89
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    81 / 299 (27.09%)
         occurrences all number
    81
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    42 / 299 (14.05%)
         occurrences all number
    42
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    44 / 299 (14.72%)
         occurrences all number
    44
    Gastrointestinal
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    23 / 299 (7.69%)
         occurrences all number
    23
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    40 / 299 (13.38%)
         occurrences all number
    40
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet completed).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet completed).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet completed).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet completed).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet completed).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet completed).

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Dec 2007
    Protocol Amendment 2 This amendment is being prepared to change the assay cut-off that that was defined as 10 mIU/ml in the original protocol to 3.3 mIU/ml. Additionally the definition of immune memory has also been included to maintain uniformity with other adult studies.

    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA