Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes Zoster vaccine GSK 1437173A; GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A
Intervention description: 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.; 2 doses administered intramuscularly (IM) in the deltoid region of the dominant arm.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 829.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: FLU-D-QIV; Adults; Safety; Immunogenicity; co-administration; Herpes zoster

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 FLU-D-QIV 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 (e.g. completion of the diary cards, return for follow-up
             visits).

          -  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)
             (HZ/su and/or FLU-D-QIV vaccines) and ending 30 days after the last dose of HZ/su
             vaccine.

          -  Administration of an influenza vaccine during the six months preceding entry into the
             study or planned administration up to the last blood sampling with the exception of
             the FLU-D-QIV vaccine given during this study.

          -  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 a VZV or HZ vaccine (including an investigational or non-registered vaccine) other
             than the study vaccine.

          -  History of HZ.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
             from disease (e.g., malignancy, 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.

          -  History of Guillain Barré syndrome.

          -  Hypersensitivity to latex.

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic
                  route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording
                  temperature in this study will be oral.

               -  Subjects with a minor illness (such as mild diarrhoea, 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
             injection unsafe.