Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder

Launched by GLAXOSMITHKLINE · May 2, 2013

Keywords

ClinConnect Summary

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.

Gender

ALL

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.