Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix-B
Intervention description: Intramuscular administration of single challenge dose of Engerix-B vaccine in the deltoid region of the non-dominant arm.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 40 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B surface antigen antibody; adult subjects; Hepatitis B; HBV

Summary:

      The purpose of this study is to assess the long-term protection against HBV infection in
      adult subjects, aged 18-40 years vaccinated with three or four doses of Engerix-B 20 to 30
      years ago
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  A male or female between and including 40 and 60 years of age (from and including the
             40th birthday up to, but excluding, the 61st birthday) at the time of the vaccination.

          -  Written informed consent obtained from the subject.

          -  Documented evidence of previous vaccination with three or four consecutive doses of
             Engerix-B administered in adulthood (i.e. at least 18 years of age) with

               -  the last dose received 4 to 12 months after the previous one,

               -  no subsequent booster dose ever received later, and

               -  the last dose received 20 to 30 years before enrolment.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche, 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 one month after vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine
             during the period starting 30 days before 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.

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period.

          -  Previous hepatitis B booster vaccination since completion of the primary vaccination
             series with three or four doses of Engerix-B.

          -  Planned administration of a vaccine not foreseen by the study protocol within 30 days
             preceding the dose of study vaccine, or planned administration during the study
             period, with the exception of seasonal influenza vaccine.

          -  Any medical condition that in the judgment of the investigator places the subject at
             undue risk by participating in the study.

          -  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 hepatitis B disease or episode of jaundice with unknown etiology.

          -  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.

          -  Major congenital defects or serious chronic illness (including insulin-dependent
             diabetes).

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or
                  38.0°C on rectal route.

               -  Subjects with a minor illness without fever may be enrolled at the discretion of
                  the investigator.

          -  Administration of immunoglobulins and/or any blood products during the period starting
             3 months before the dose of study vaccine, or planned administration during the study
             period.

          -  Drug and/ or alcohol abuse within the last 5 years.