Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes Zoster vaccine GSK 1437173A; Boostrix
Intervention description: 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.; 1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 935.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Boostrix; Herpes zoster; Immunogenicity; Co-administration; Adults; Safety

Summary:

      The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK
      Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine
      in adults aged 50 years or older compared to administration of vaccines separately.
    

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 (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  Chronic administration (defined as more than 14 consecutive days) of
             immunosuppressants or other immune-modifying drugs within six months prior to the
             first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or
             equivalent). 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 (but not limited to) live, inactivated and subunit vaccines (e.g.,
             inactivated and subunit influenza vaccines).

          -  Administration of long-acting immune-modifying drugs (e.g. infliximab) 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 (pharmaceutical product or device).

          -  Previous vaccination against VZV or HZ and/or planned administration during the study
             of an HZ or VZV vaccine (including an investigational or non-registered vaccine) other
             than the study vaccine.

          -  History of HZ.

          -  Vaccination against diphtheria, or tetanus in the last five years or planned
             vaccination against diphtheria or tetanus during the study period, other than the
             study vaccine(s).

          -  Administration of a combined tetanus, diphtheria and pertussis (Tdap) vaccine at any
             time prior to study entry.

          -  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).

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines including prior severe allergic reaction following tetanus-toxoid,
             diphtheria-toxoid or pertussis-containing vaccine.

          -  Hypersensitivity to latex. Note: The investigational HZ/su vaccine does not contain
             latex.

          -  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 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.

          -  Encephalopathy (e.g. coma, decreased consciousness, prolonged seizures) not
             attributable to an identifiable cause within 7 days of administration of a previous
             pertussis antigen-containing vaccine.

          -  Progressive or unstable neurologic disorder.

          -  History of Arthus-type hypersensitivity reaction following a prior dose of a
             tetanus-toxoid containing vaccine within the last 10 years.

          -  History of Guillain-Barré syndrome within 6 weeks of receipt of a prior vaccine
             containing tetanus toxoid.