Last updated: 11/07/2018 02:59:06

Long-term persistence of immunity against hepatitis B in 7-8 years old children after hepatitis B vaccination.

GSK study ID
110474
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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).
Trial description: The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Timeframe: One month after the challenge dose of HBV vaccine

Secondary outcomes:

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

Timeframe: Before challenge dose of HBV vaccine

Number of Participants reporting Solicited Local Symptoms

Timeframe: During the 4-day follow-up period after the challenge dose of HBV vaccine.

Number of Participants reporting Solicited General Symptoms

Timeframe: During the 4-day follow-up period after the challenge dose of HBV vaccine.

Number of Participants reporting Unsolicited adverse events

Timeframe: During the 31-day follow-up period after the challenge dose of HBV vaccine.

Number of Participants reporting serious adverse events (SAE)

Timeframe: After the challenge dose of HBV vaccine.

Interventions:
  • Biological/vaccine: Engerix™-B Kinder
  • Enrollment:
    301
    Primary completion date:
    2007-31-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Behre U et al. (2012) Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination. Hum Vaccin Immunother. 8(6):813-818.
    Medical condition
    Hepatitis B Vaccine
    Product
    SKF103860
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to December 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    7 - 8 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
    • A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
    • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
    • Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix™-B vaccine.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Muenster, Nordrhein-Westfalen, Germany, 48163
    Status
    Study Complete
    Location
    GSK Investigational Site
    Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 12679
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Offenburg, Baden-Wuerttemberg, Germany, 77654
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13055
    Status
    Study Complete
    Location
    GSK Investigational Site
    Loehne, Nordrhein-Westfalen, Germany, 32584
    Status
    Terminated/Withdrawn
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    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-31-12
    Actual study completion date
    2007-31-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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