A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous; ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous; ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal; ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal; Full Dose Intradermal Placebo; Intradermal Placebo
Intervention description: One 0.65 mL injection subcutaneously on Day 1; One approximately 0.22 mL injection subcutaneously on Day 1; Two intradermal injections of approximately 0.15 mL each on Day 1; One intradermal injection of approximately 0.1 mL on Day 1; Two intradermal placebo injections of approximately 0.15 mL each on Day 1; One intradermal placebo injection of approximately 0.1 mL on Day 1
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 223.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both
      intradermally and subcutaneously at various doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior history of varicella (chickenpox) or residence in a country with endemic
             varicella zoster virus infection for at least 30 years

          -  Temperature less than 100.4 °F on day of vaccination

          -  Female participants of reproductive potential must have a negative pregnancy test and
             agree to remain abstinent or use two acceptable contraceptive methods for 3 months
             postvaccination

          -  In good health

        Exclusion Criteria:

          -  History of hypersensitivity reaction to any vaccine component, including gelatin or
             neomycin

          -  Household exposure to pregnant women who have not had chickenpox and have not been
             vaccinated against varicella or to immunosuppressed/immunodeficient individuals

          -  Household or workplace exposure to children 18 months and younger who have not been
             vaccinated against varicella

          -  Prior history of herpes zoster

          -  Prior receipt of any varicella or zoster vaccine

          -  Received or is expected to receive immune globulin and/or blood products from 5 months
             prior to randomization through 42 days after vaccination

          -  On immunosuppressive therapy

          -  Known or suspected immune dysfunction

          -  Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4
             weeks prior to study vaccination through the completion of all study visits

          -  Received any inactivated vaccine or is scheduled to receive any inactivated vaccine
             from 7 days prior to study vaccination through 7 days postvaccination, except for
             inactivated influenza vaccine

          -  Not ambulatory

          -  Pregnant or breastfeeding

          -  Use of nontopical antiviral therapy with activity against herpes viruses

          -  Active untreated tuberculosis