Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B Kinder
Intervention description: Single dose administered intramuscularly in the deltoid region of non-dominant arm at Day 0.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 15 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Hepatitis B; Adolescents; Engerix™-B Kinder

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.
    

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.