Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older

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).