Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: HZ/su vaccine GSK1437173A; Prevenar13
Intervention description: 2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.; 1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 913.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HZ; Safety; Immunogenicity; Shingles; Adults; Prevenar 13

Summary:

      The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ
      vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate
      vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two
      HZ/su doses are administered subsequent to Prevenar13.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  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 the first vaccination with the study
             vaccine(s).

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  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
             during the period starting 30 days before the first dose of study vaccines (Day -30 to
             Day 1), or planned use during the study period.

          -  Any medical condition that in the judgment of the investigator would make
             intramuscular (IM) injection unsafe.

          -  Use or anticipated use of immunosuppressants or other immune-modifying drugs during
             the period starting six months 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 or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular
             corticosteroids are allowed.

          -  Administration or planned administration of a vaccine not foreseen by the study
             protocol in the period starting 30 days before the first dose and ending 30 days after
             the last dose of study vaccine administration. This includes any type of vaccine such
             as (but not limited to) live, inactivated and subunit vaccines.

          -  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 and/or planned administration of an HZ or VZV vaccine other than the study
             vaccine during the study period.

          -  History of HZ.

          -  History of documented pneumococcal infection within 5 previous years.

          -  Prior receipt of any pneumococcal vaccine or planned use during the study period,
             other than the study vaccines.

          -  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 enrollment.

               -  Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for
                  measuring temperature in this study will be the oral cavity.

               -  Subjects with a minor illness without fever may, be enrolled at the discretion of
                  the investigator.

          -  Administration of immunoglobulins and/or any blood products during the period starting
             3 months before 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 person with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal
             failure, nephrotic syndrome and functional or anatomic asplenia.

          -  Any medical condition that in the judgment of the investigator would prevent the
             subject from participating in the study.