evaluation of the long-term persistence of immunity to hepatitis b, in adolescents vaccinated in infancy with engerix™-b kinder

Conditions: Hepatitis B

Summary: the purpose of this study is to assess the long-term persistence of immunity to hepatitis b in adolescents aged 15-16 years who were vaccinated with engerix™-b kinder in infancy. the study will also assess the immune response to a challenge dose of engerix™-b kinder in these subjects.

this mdd has been updated following the protocol amendment 1, dated 20 june 2013. the protocol was amended because gsk replaced its in-house enzyme-linked immunosorbent assay (elisa) that was used to measure anti-hbs (antibodies to hepatitis b surface antigen) antibody concentrations with chemiluminescence immunoassay (clia). additionally, the threshold level of prednisone was modified to reflect the dosage normally prescribed to adolescents.

Eligibility criteria:
inclusion criteria: * subject's parent(s)/guardians who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * a male or female between, and including, 15 and 16 years of age at the time of the vaccination. * 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). * 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. * female subjects of non-childbearing potential may be enrolled in the study. * non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. * chronic administration 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. * 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. * acute disease and/or fever at the time of enrollment. * fever is defined as temperature ≥ 37.5°c for oral, axillary or tympanic route, or ≥ 38.0°c on rectal route. the preferred route for recording temperature in this study will be axillary. * subjects with a minor illness without fever may be enrolled at the discretion of the investigator. * administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccine dose or planned administration during the study period. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions.

Keywords: healthy hepatitis b adolescents engerix™-b kinder