Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B
Intervention description: A challenge dose of hepatitis B vaccine will be administered to all subjects as a deep intramuscular injection in the deltoid region of the non-dominant arm.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis; vaccine

Summary:

      In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at
      0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for
      immunological memory to hepatitis B vaccine via assessment of the response to a vaccine
      challenge dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  A male or female adult who received the complete neonatal primary vaccination course
             of hepatitis B vaccine (Engerix™-B), in the 103860/272 primary study approximately 20
             years earlier.

          -  Documented level of anti-HBs antibody concentrations < 100 milli-international units
             per milliliter (mIU/ml) at the previous long-term time-point for which serological
             results are available for that subject.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  If the subject is female, she must be of non-childbearing potential or if she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination, have a negative pregnancy test and continue such precautions for 2 months
             after completion of the hepatitis B challenge dose.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the hepatitis B vaccine challenge
             dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting from 30 days before the hepatitis B vaccine challenge dose
             and ending 30 days after.

          -  Subjects who received a booster dose of hepatitis B vaccine outside the context of
             this study between the long-term time-point at the documented level of anti-HBs
             antibody concentrations and the current challenge dose study visit.

          -  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 product.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  Acute disease at the time of enrolment.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the hepatitis B vaccine challenge dose or planned administration during the
             study period.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.