Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix-B™; Fendrix™; GSK Biologicals' Hepatitis B vaccines (GSK223192A); HBsAg (Booster injection)
Intervention description: 2 doses intramuscular injections; 2 doses intramuscular injections; 2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group; Single dose intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 713.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adjuvant Systems; Hepatitis B

Summary:

      The aim of this Observer-blind study is to compare different Adjuvant Systems with the same,
      well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B
      (Engerix-BTM and FendrixTM), in order to better understand the immune response induced by
      each of the Adjuvant System.

      This Protocol Posting has been updated following Protocol amendment 6, October 2009. The
      section impacted is Eligibility Criteria
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy the following criteria at study entry :

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A male or female between, and including, 18 and 45 years at the time of the first
             vaccination.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects as established by medical history, clinical examination and clinical
             laboratory assessment 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 series.

        Exclusion criteria:

        The following criteria should be checked at the time of study entry. If any apply, the
        subject must not be included in the study:

          -  Previous vaccination against Hepatitis B.

          -  Positive for anti-HBs antibodies, antiHBc antibodies, HBsAg, HCV antibodies and/or
             HIV.

          -  Any previous administration of specific adjuvant components.

          -  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 or participation to another pharmaceutical/vaccine study.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of the first dose of vaccine with the exception of the influenza
             vaccine (pandemic or seasonal) which can be administered > 21 days preceding or > 21
             days following each primary vaccine dose (Doses 1 and 2) AND > 7 days preceding or > 7
             days following the booster dose.

          -  Administration of immunoglobulins and/or any blood products within the last 3 months.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s).

          -  Current serious neurologic or mental disease.

          -  Any past or current malignancies and lymphoproliferative disorders.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal
             functional abnormality, autoimmune disease or anemia, as determined by physical
             examination or laboratory screening tests at the discretion of the investigator.

          -  Acute disease at the time of enrolment.

          -  Pregnant or lactating female.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Other conditions that the principal investigator judges may interfere with study
             findings.