Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes zoster vaccine GSK1437173A; Placebo
Intervention description: 2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations); 2 vaccinations at Months 0 and 2 with placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 410.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cytokine; Vaccine; Herpes Zoster (HZ); Cell mediated immunity (CMI); Antibody response; Varicella Zoster Virus (VZV); Shingles

Summary:

      The goal of this randomized observer-blind trial is to further refine the formulation of
      vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune
      responses and the safety profiles of the different formulations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female 50 years of age or above at the time of the first vaccination;

          -  Written informed consent obtained from the subject;

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study;

          -  If the subject is female, she must be of non-childbearing potential, or if she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination, have a negative pregnancy test and continue such precautions 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 vaccine(s) 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 three months prior to the
             first vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within one month before the first study vaccination or scheduled within 30 days after
             study vaccination;

          -  Previous vaccination against HZ;

          -  Previous vaccination against varicella;

          -  History of HZ;

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine;

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
             from disease or immunosuppressive/cytotoxic therapy;

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first injection of study vaccine or planned administration during the
             study period;

          -  Acute disease at the time of enrolment.

          -  Any other condition that, in the opinion of the investigator, might interfere with the
             evaluations required by the study;

          -  History of or current drug and/or alcohol abuse;

          -  Pregnant or lactating female;

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions if of childbearing potential.