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.
Conditions
Interventions
Trade Name: Engerix-B Kinder
Product Name: Engerix-B
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis B surface antigen
Concentration unit: µg/ml microgram(s)/millilitre
Co
Sponsors
GSK Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: Anti-HBs antibody concentrations >= 100 mIU/ml. ;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. 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. | — |
Countries
Germany
Outcome results
None listed