Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes Zoster Vaccine GSK1437173A
Intervention description: Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8687.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Herpes Zoster; Safety; Adults; Cross-vaccination

Summary:

      The purpose of this study is to cross-vaccinate and collect safety data in terms of
      unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated
      Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in
      ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).
    

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, vaccination visits,
             follow-up contacts). Or subjects' Legally Acceptable Representative(s)
             [LAR(s)]/caregiver who, in the opinion of the investigator, can and will comply with
             the requirements of the protocol (e.g. completion of the diary cards, vaccination
             visits, availability for follow-up contacts).

          -  Written informed consent obtained from the subject/Legally Acceptable
             representative(s) [LAR(s)] of the subject prior to performing any study specific
             procedure. If the subjects is not capable of giving consent, his/her assent to
             participate should be obtained to the extent possible.

          -  Subject who previously participated in ZOSTER-006 or ZOSTER-022 studies and received
             at least one dose of placebo.

          -  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.

                    -  treatment period refers to vaccination days and the interval between them.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine during the period starting 30 days before the first dose of study
             vaccine (Day -29 to Day 0), or planned use up to 30 days post Dose 2.

          -  Previous vaccination against Varicella Zoster virus (VZV) or HZ.

          -  Planned administration of VZV or HZ vaccination during the study (including an
             investigational or non-registered vaccine), with the exception of the study vaccine.

          -  Planned administration/administration of a vaccine/product 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 vaccine administration, with the exception of licensed
             non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated
             and subunit influenza vaccines, with or without adjuvant for seasonal or pandemic
             flus). These may be administered up to 8 days prior to dose 1 and/or dose 2 and/or at
             least 14 days after any dose of study vaccine

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs during the period starting six months prior to the
             first vaccine dose and up to 30 days post Dose 2. For corticosteroids, this will mean
             prednisone ≥ 20 mg/day or equivalent. Inhaled, topical and intra-articular
             corticosteroids are allowed.

          -  Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab)
             within six months prior to the first vaccine dose up to 30 days post Dose 2.

          -  Concurrently participating in another clinical study, at the time of enrolment or
             planned participation up to the 30 days post second dose, in which the subject has
             been or will be exposed to an investigational or a non-investigational vaccine/product
             (pharmaceutical product or device).

          -  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 vaccine.

          -  Active HZ infection at the time of enrolment (i.e. HZ lesions not completely crusted
             over).

          -  Pregnant or lactating female.

          -  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.