Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: Herpes Zoster vaccine GSK1437173A Low Dose; Herpes Zoster vaccine GSK1437173A Medium Dose; Herpes Zoster vaccine GSK1437173A High Dose; Herpes Zoster vaccine GSK1437173A Modified; Placebo
Intervention description: Single or two-dose intramuscular injection.; Single or two-dose intramuscular injection.; Single or two-dose intramuscular injection.; Single or two-dose intramuscular injection.; Single intramuscular injection
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 715.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK Biologicals; Herpes Zoster (HZ); Vaccine; Varicella Zoster Virus (VZV); Shingles

Summary:

      Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK
      candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II
      study will be subdivided into a primary study (108494) and three extension studies (108516,
      108518 & 108520), consisting of one additional visit each at months 12, 24 and 36,
      respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the
      primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the
      GSK1437173A vaccine in healthy elderly population. The study population will be stratified by
      age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim
      of the extension studies is to evaluate the persistence of the immune response induced by the
      candidate HZ vaccine during a long term period.

      No new subjects will be enrolled during the extension phases of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A male or female aged 60 years or older at the time of the first vaccination.

          -  Written informed consent obtained from the subject

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first injection with study vaccine, or
             planned use during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs during the study period, except inhaled and topical steroids
             are allowed.

          -  Administration or planned administration of a vaccine not foreseen by the study
             protocol within 2 weeks of the first study vaccine injection, with the exception of
             the influenza vaccine, which can be administered 1 week preceding or 1 month after the
             first study vaccine injection.

          -  Previous vaccination against HZ.

          -  History of herpes zoster (Shingles).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at the time of enrolment.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by subject's medical history or physical
             examination as assessed by the investigator.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first injection of study vaccine or planned administration during the
             study period.

          -  History of or current drug and/or alcohol abuse.