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). - HBV-315 PRI
- Conditions
- Antibody persistence and hepatitis B vaccine challenge in children 7-8 years of age, previously vaccinated with 3 doses of GSK Biologicals’ HBV vaccine in routine vaccination practice in Germany.
- Registration Number
- EUCTR2007-002221-76-DE
- Lead Sponsor
- GSK Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 (pharmaceutical product or device).
Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix™-B vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Primary end point(s): One month after the challenge dose of HBV vaccine:<br>Anti-HBs antibody concentrations >= 100 mIU/ml.<br>;Secondary Objective: To assess the persistence of anti-HBs antibodies in subjects, 7-8 years of age, previously vaccinated with three doses of Engerix-B in infancy.<br>To evaluate the safety and reactogenicity of a challenge dose of HBV vaccine (Engerix-B Kinder) in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs) during the study period.<br>
- Secondary Outcome Measures
Name Time Method