Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Engerix™-B vaccine
Intervention description: 3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 667.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Engerix™-B; hepatitis B; adults; Type 2 diabetes mellitus

Summary:

      This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine)
      when administered as a primary vaccination course at 0, 1 and 6 months in adults with or
      without type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  A male or female subject aged 20 years and above at the time of screening.

          -  Written informed consent obtained from the subject at screening.

          -  Subjects diagnosed with type 2 diabetes documented within the past five years,
             according to the criteria specified by the American Diabetes Association or currently
             taking any form of anti-diabetic intervention documented by the investigator; or
             control subjects with no diagnosis or documented history of diabetes, and HbA1c less
             than 6.5%, as determined by laboratory screening tests.

          -  Normal renal function defined as estimated glomerular filtration rate (GFR) ≥ 50
             mL/min, estimated through the Modification of Diet in Renal Disease (MDRD) or the
             Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, as determined by
             laboratory screening tests.

          -  Seronegative for hepatitis B surface antigen (HBsAg), anti-HBs antibodies and
             antibodies to hepatitis B core antigen (anti HBc), as determined by laboratory
             screening tests.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche, current tubal ligation,
                  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 screening and at Visit 1, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for two months after completion of the vaccination series.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If ANY exclusion
        criterion applies, the subject must not be included in the study:

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first 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 first vaccine dose.

          -  Administration of long-acting immune-modifying drugs within 6 months of the study
             entry or planned administration at any time during the study period.

          -  Administration of a vaccine not foreseen by the study protocol starting from 30 days
             before each dose of vaccine and ending 30 days after each dose, with the exception of
             the inactivated influenza vaccine which is allowed at any time during the study if
             administered at a separate site.

          -  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
             protocol-specified non-investigational product.

          -  Any previous complete or incomplete vaccination against hepatitis B since birth.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             HIV infection, based on medical history and physical examination.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine, including latex.

          -  Advanced heart failure or any other severe clinical condition that significantly
             reduces the subject's life expectancy.

          -  Acute disease and/or fever at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Any history of alcohol or drug abuse in the past 5 years.