Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes zoster vaccine GSK1437173A
Intervention description: 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 354.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ≥ 50 years of age; Herpes zoster; Safety; Immunogenicity; Adults

Summary:

      The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals'
      HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged
      50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer
      than two months is not known.
    

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 aged 50 years or older at the time of the first vaccination.

          -  Written informed consent obtained from the subject.

          -  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 vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for two months after completion of the vaccination series.

        Exclusion Criteria:

          -  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. For corticosteroids, a prednisone dose of
             < 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular
             corticosteroids are allowed.

          -  Administration or planned administration of a live vaccine in the period starting 30
             days before and ending 30 days after either dose of study vaccine.

          -  Administration or planned administration of a non-replicating vaccine within eight
             days prior to or within 14 days after either dose of study vaccine.

          -  Administration of long-acting immune-modifying drugs (e.g. infliximab) within six
             months prior to the first vaccine dose or expected administration at any time during
             the study period.

          -  Previous vaccination against varicella or HZ (either registered product or
             participation in a previous vaccine study).

          -  Planned administration during the study of an HZ or varicella vaccine (including an
             investigational or non-registered vaccine) other than the study vaccine.

          -  History of HZ.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s).

          -  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) for oral, axillary or tympanic
                  route, or ≥ 38.0°C (100.4°F) for rectal route. The preferred route for recording
                  temperature in this study will be oral.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.

          -  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.

          -  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.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant during the entire treatment period and for two
             months after completion of the vaccination series, or planning to discontinue
             contraceptive precautions (if of childbearing potential).