Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GlaxoSmithKline (GSK) Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
Intervention description: 2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm on a 2 month schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 404.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Herpes Zoster; Reactogenicity; Quality of life; Shingles

Summary:

      The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals'
      HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age
    

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 questionnaires and diary cards).

          -  Written informed consent obtained from the subject prior to performance of any study
             specific procedure.

          -  A male or female aged ≥ 50 YOA at the time of consent.

          -  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.

          -  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 2 months after completion of the vaccination series.

        Exclusion Criteria:

          -  Any condition which, in the judgment of the investigator, would make intramuscular
             (IM) injection unsafe.

          -  Use or planned use of any investigational or non-registered product (drug or vaccine)
             other than the study vaccine or current participation or planned concurrent
             participation in another clinical study, in which the subject has been or will be
             exposed to an investigational or a non-investigational product (pharmaceutical product
             or device) during the period starting 30 days before the first dose of study vaccine
             and the study end.

          -  Use or anticipated use of immunosuppressants or other immune-modifying drugs during
             the period starting 180 days 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). Inhaled, topical and intra-articular corticosteroids are allowed.

          -  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).

          -  Administration of immunoglobulins and/or any blood products in the period starting 90
             days preceding the first dose of study vaccine or planned administration during the
             study period.

          -  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 in the period starting 15 days prior to and ending 14 days after either dose
             of study vaccine.

          -  Previous or planned administration of a vaccine against HZ (including an
             investigational or non-registered vaccine) other than the study vaccine, during the
             entire study period.

          -  History of HZ.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Pregnant or lactating female.

          -  Significant underlying illness requiring medications that might confound the
             evaluation of general/ local AEs, or 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.