Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older
Condition: Herpes Zoster; Herpes Zoster Vaccine
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes Zoster vaccine GSK 1437173A; Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™
Intervention description: 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.; One dose administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 865.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumovax 23; Co-administration; Herpes zoster; Immunogenicity; Safety; Adults

Summary:

      The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the
      GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax
      23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™
      vaccine immune response will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  A male or female aged 50 years or older at the time of the first vaccination with the
             study vaccine(s).

          -  Written informed consent obtained from the subject.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche, 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:

          -  Use of any investigational or non-registered product other than the study vaccines
             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. A prednisone dose of < 20 mg/day is
             allowed. Inhaled, topical and intra-articular corticosteroids are allowed.

          -  Administration or planned administration of a vaccine not foreseen by the study
             protocol within the period starting 30 days before the first dose of study vaccine(s)
             and ending 30 days after the last dose of study vaccine. This includes any type of
             vaccine such as live, inactivated and subunit vaccines.

          -  Administration of long-acting immune-modifying drugs within six months prior to the
             first vaccine dose or expected administration at any time 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 vaccine/product.

          -  Previous vaccination against Varicella-zoster virus (VZV) or HZ and/or planned
             administration during the study of an HZ or VZV vaccine other than the study vaccine.

          -  History of HZ.

          -  History of documented pneumococcal infection within 5 previous years.

          -  Prior receipt of any pneumococcal vaccine or planned use of this vaccine during the
             study period, other than the study vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
             from disease or immunosuppressive/cytotoxic therapy .

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred
                  route for recording temperature in this study will be oral.

               -  Subjects with a minor illness (such as mild diarrhea, 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 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions before 2 months after the last dose of study vaccine.

          -  Any persons with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal
             failure, nephrotic syndrome, and functional or anatomic asplenia.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participating in the study.

          -  Any condition which, in the judgment of the investigator, would make intramuscular
             (IM) injection unsafe.