Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Intervention: EngerixTM-B
Intervention description: Intramuscular injection, one dose.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 19 Years
Maximum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Engerix-B; Hepatitis B

Summary:

      This study will evaluate the immune response of healthy subjects who received neonatal
      vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The
      presence of immune memory against hepatitis B surface antigen (HBsAg) in these subjects will
      be investigated by the administration of a challenge dose of hepatitis B vaccine and the
      comparison of their antibody concentration before and one month after vaccination.

      This protocol posting deals with objectives & outcome measures of the booster phase. No new
      subjects will be recruited during this booster phase of the study.
    

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 who received the complete neonatal primary vaccination course of
             Engerix™-B in the 103860/273 primary study approximately 20 years earlier.

          -  Anti-HBs antibody concentrations less than the specified value at the last available
             follow-up time-point.

          -  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 vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the Engerix™-B challenge dose, or planned use
             during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressant or other
             immune-modifying drugs within six months prior to challenge dose administration.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             starting from 30 days before the challenge dose and ending 30 days after.

          -  Administration of a hepatitis B vaccine outside the context of this study between the
             follow-up time-point at which anti-HBs antibody concentrations was less than the
             specified value 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.

          -  Acute disease at the time of enrolment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  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 challenge dose visit or planned administration during the study period.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.