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 challenge dose of Engerix™-B Kinder in adolescents 15-16 years of age who were vaccinated in infancy with three doses of Engerix™-B Kinder. - HBV-319

Overview

No summary available.

Registry

who.int

Start Date

January 7, 2013

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•A male or female between, and including, 15 and 16 years of age (from and including the 15th birthday up to but excluding the 17th birthday) at the time of the vaccination.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Documented evidence of previous vaccination with three consecutive doses of Engerix™\-B Kinder in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age (up to but excluding the first day of the 10th and 19th month, respectively).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 300
•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

•Child in care.
•Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune\-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone \>\= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
•Previous hepatitis B vaccination since administration of the third dose of Engerix™\-B Kinder.
•History of hepatitis B disease.
•Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study vaccine dose, or planned administration during the study period.
•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 vaccine/product (pharmaceutical product or device).
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Acute disease and/or fever at the time of enrolment.