Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes Zoster Vaccine GSK1437173A; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 16165.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: subjects 50 years and older; vaccine; immunogenicity; efficacy; Herpes Zoster; safety

Summary:

      The purpose of this observer-blind study is to evaluate the efficacy, safety and
      immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50
      years.

      Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted
      concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both
      studies combined will be conducted contingent on each study achieving its objectives. The
      protocol posting of study ZOSTER-022 also deals with the outcome measures related to the
      pooled analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes will comply with the requirements of the
             protocol;

          -  Written informed consent obtained from the subject;

          -  A male or female aged 50 years or older at the time of the first vaccination;

          -  Female subjects of non-childbearing potential may be enrolled in the study;

        For this study population, non-childbearing potential is defined as current tubal ligation,
        hysterectomy, ovariectomy or post-menopause.

        OR 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
        urine pregnancy test on the day of vaccination, and has agreed to continue adequate
        contraception during the entire treatment period and for 2 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;

          -  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
             non-investigational product;

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
             from disease or immunosuppressive/cytotoxic therapy;

          -  History of HZ;

          -  Previous vaccination against varicella or HZ;

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine. Additionally, consider allergic reactions to other material or equipment
             related to study participation;

          -  Significant underlying illness that in the opinion of the investigator would be
             expected to prevent completion of the study;

          -  Receipt of immunoglobulins and/or any blood products within the 90 days preceding the
             first dose of study vaccine or planned administration during the study period;

          -  Administration or planned administration of any other immunizations within 30 days
             before the first or second study vaccination or scheduled within 30 days after study
             vaccination. However, licensed non-replicating vaccines may be administered up to 8
             days prior to each dose and/or at least 14 days after any dose of study vaccine;

          -  Any other condition that, in the opinion of the investigator, might interfere with the
             evaluations required by the study;

          -  Acute disease and/or fever at the time of enrollment;

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Pregnant or lactating female;

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.