ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: Zoster Vaccine, Live; Comparator: placebo
Intervention description: single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.; single 0.65 mL Placebo injection. 6 month treatment period.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11999.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years
      of age or older as required by the FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60+ years of Age

          -  Signed an informed consent prior to the start of study

          -  Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination

          -  Females must be postmenopausal or have a negative pregnancy test

        Exclusion Criteria:

          -  A history of allergic reaction to any vaccine component (including gelatin or
             neomycin)

          -  Prior receipt of any varicella or zoster vaccine

          -  Any live virus vaccine administered within 4 weeks before the start of the study or
             scheduled during the 42 days after vaccination

          -  Any inactivated virus vaccine, except for flu vaccine, administered within 7 days
             before the start of the study or scheduled during the 42 days after vaccination

          -  Subject is pregnant or breastfeeding

          -  Participation in an investigational drug or vaccine study within the last 30 days
             prior to the start of the study or expected during the 42 days after vaccination

          -  An ongoing illness (including active untreated tuberculosis) that might interfere with
             or prevent the subject from completion of the study

          -  Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone
             should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic
             agents used to treat cancer or other conditions, and treatments associated with organ
             or bone marrow transplantation

          -  Known or suspected immune dysfunction that is caused by a medical condition or any
             other cause. Examples of medical conditions associated with immune dysfunction include
             congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or
             bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma,
             or generalized malignancy. Subjects with a history of cancer who are not on active
             treatment and are not thought to have a weakened immune system at the time of
             enrollment will be eligible

          -  Any active use of non-topical antiviral therapy including but not limited to
             acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir