Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
Condition: Herpes Zoster; Herpes Zoster Vaccine
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, Care Provider, Outcomes Assessor)
Enrollment: 14819.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Subjects 70 years and older; Efficacy; Herpes Zoster; Safety; Adults; Vaccine

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 ≥ 70
      years.

      Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be 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. This
      protocol posting 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 70 years or older at the time of the first vaccination.

        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 enrolment.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.