Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B
Intervention description: One dose (10µg Hepatitis B surface antigen (HBsAg))
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 17 Years
Maximum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B; Persistence; Challenge dose

Summary:

      To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when
      given to subjects who had received primary vaccination of Engerix™-B vaccine approximately
      72-78 months ago.

      This protocol posting deals with objectives & outcome measures of the challenge phase. The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A male or female who had received complete primary vaccination course of hepatitis B
             vaccine in the primary study

          -  Written informed consent obtained from the subject and/or parent/guardian of 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 the hepatitis B challenge dose.

        Exclusion Criteria:

          -  Use of any investigational/non-registered drug or vaccine other than the study vaccine
             within 30 days preceding the hepatitis B vaccine challenge dose or planned use during
             the study period.

          -  Chronic administration (more than 14 days) of immunosuppressants 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 an additional dose of hepatitis B vaccine outside the context of
             the study between the primary vaccination course and the hepatitis B challenge
             vaccination 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, based on
             medical history and physical examination.

          -  Acute disease at the time of enrolment.

          -  Acute or chronic, clinically significant 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 (one month).

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.