Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
Intervention description: 2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 430.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Zostavax®; ≥ 65 years of age; Herpes Zoster; Shingles; Immunogenicity; Safety

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5
      years earlier.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  A male or female ≥ 65 years of age at the time of the first vaccination.

          -  Written informed consent obtained from the subject prior to performing any study
             specific procedure.

        For the No prev-Zvax group only:

        • No previous vaccination with Zostavax.

        For the Prev-Zvax group only:

        • Previous vaccination with Zostavax ≥ 5 calendar years earlier.

          -  Documentation indicating the date of previous Zostavax vaccination will be required.

        Exclusion Criteria:

          -  Previous vaccination with Zostavax < 5 calendar years earlier and/or anyone that ever
             received more than a single dose of Zostavax.

          -  Previous vaccination against VZV, administration of HZ/su vaccine or any other
             investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax
             group).

          -  Use of any investigational or non-registered product other than the study vaccine
             during the period starting 30 days before the first dose of study vaccine, or planned
             use during the study period.

          -  Chronic administration (defined as > 14 consecutive days) of immunosuppressants or
             other immune-modifying drugs in the period starting 6 months prior to the first dose
             of vaccine. (For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is
             allowed.) Inhaled, topical and intra-articular corticosteroids are allowed.

          -  Administration of long-acting immune-modifying drugs (e.g., infliximab) in the period
             starting 6 months prior to the first vaccine dose or expected administration at any
             time during the study period.

          -  Administration or planned administration of a live vaccine in the period starting 30
             days before the first dose of study vaccine and ending 30 days after the last dose of
             study vaccine, or, administration or planned administration of a non-replicating
             vaccine in the period starting 8 days prior to and ending 14 days after either dose of
             study vaccine.

          -  Current participation in or planned concurrent participation 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.

          -  Planned administration of an HZ vaccine (including an investigational or
             non-registered vaccine) other than the study vaccine during the entire study.

          -  History of HZ or any suspected HZ between the screening visit and Visit 1.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine/product.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
             from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or
             immunosuppressive/cytotoxic therapy (e.g., medications used during cancer
             chemotherapy, organ transplantation or to treat autoimmune disorders).

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥ 37.5°C (99.5°F) by oral route, axillary or
                  tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The recommended route
                  for recording temperature in this study will be oral.

               -  Subjects with a minor illness (such as mild diarrhea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.

          -  Administration of immunoglobulins and/or any blood products in the period starting 3
             months preceding the first dose of study vaccine or planned administration during the
             study period.

          -  Significant underlying illness that, in the opinion of the investigator, would be
             expected to prevent completion of the study.

          -  Any other condition that, in the opinion of the investigator, might interfere with the
             evaluations required by the study.

          -  Any condition which, in the judgment of the investigator, would make intramuscular
             (IM) injection unsafe.