Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes Zoster Vaccine GSK1437173A
Intervention description: Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 68 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Safety; Long term follow-up; Adults; Herpes zoster

Summary:

      The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine
      as well as safety up to 10 years after the first dose of initial vaccination course. This
      study will also assess immune responses after re-vaccination with 2 additional doses of the
      HZ/su administered at ten years after first dose of initial vaccination course from study
      Zoster-003 (NCT00434577).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol (e.g., completion of the diary cards, return for
             follow-up visits, ability to have scheduled contacts to allow evaluation during the
             study). Or subjects with a caregiver who, in the opinion of the investigator, can and
             will comply with the requirements of the protocol (e.g., completion of the diary
             cards, vaccination visits, availability for follow-up contacts).

          -  Written informed consent obtained from the subject prior to performance of any study
             specific procedure.

          -  Previous participation in study ZOSTER-003 (NCT00434577), in group 50 µg gE / AS01B,
             and who completed the vaccination course (2 doses of HZ/su) in study ZOSTER-003
             (NCT00434577).

          -  Subjects are expected to enter the study (or complete Visit 1) as of the time they
             turn 108 months after first vaccination of previous vaccination course with HZ/su and
             not later than 111 months.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine during the period starting 30 days before the first study visit (Day -29
             to Day 0), or planned use during the study period.

          -  Use or anticipated use of immunosuppressants or immune-modifying drugs during the
             period starting six months prior to study start and during the whole study period.
             This includes chronic administration of corticosteroids (>14 consecutive days of
             prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune-modifying
             agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications
             used during cancer chemotherapy, organ transplantation or to treat autoimmune
             disorders).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
             from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection).

          -  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* within 8 days prior to or within 14 days after either dose of study vaccine.

        E.g., inactivated and subunit vaccines, including inactivated and subunit influenza
        vaccines and pneumococcal conjugate vaccines.

          -  Previous vaccination against HZ since initial vaccination in Zoster-003.

          -  Administration of immunoglobulins and/or any blood products during the period starting
             3 months before the study start, or planned administration during the study period.

          -  History of previous HZ.