Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058)
Condition: Varicella
MeSH terms: Chickenpox
Intervention: VARIVAX™
Intervention description: VARIVAX™ administered by SC injection as 0.5 mL Varicella Virus Vaccine Live in sterile suspension on Day 1 (all participants) and Day 43 (adult and adolescent participants).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 12 Months
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study was to evaluate the immunogenicity and safety of VARIVAX™ vaccine
      in healthy Russian children, adolescents, and adults. No formal hypothesis was tested.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has a negative clinical history for varicella and herpes zoster

          -  females of reproductive potential have a negative pregnancy test prior to each study
             vaccination

          -  females of reproductive potential remain abstinent or use 2 acceptable methods of
             birth control during study until 3 months following last study vaccination

          -  females not of reproductive potential do not require a pregnancy test or use of
             contraceptives

          -  legal representative of adult or parent of children understands risks involved with,
             consent to participate in, and comply with the study procedures

        Exclusion Criteria:

          -  has a history of allergy or anaphylactic reaction to neomycin, gelatin, or any
             component of VARIVAX^TM

          -  has received any form of varicella or herpes zoster vaccine at any time prior to
             study, or anticipates receiving any during study

          -  has received immune globulin, a blood transfusion or blood derived products within
             prior 5 months or plans to do so during study

          -  has received aspirin or any aspirin-containing products within prior 14 days

          -  has been exposed to varicella or herpes zoster in the prior 4 weeks involving
             playmate, hospital or continuous household contact, or had contact with a newborn
             whose mother had chickenpox 5 days before or 2 days after delivery

          -  has, or lives with a person who has, any congenital or acquired immune deficiency,
             neoplastic disease, or depressed immunity including those resulting from
             corticosteroid use or other immunosuppressive therapy

          -  has received glucocorticosteroids for more than 5 consecutive days within prior 3
             months, or any dose of glucocorticoids within prior 7 days, or expects to use
             glucocorticosteroids during the study

          -  was vaccinated with licensed non-live or live vaccine within prior 30 days or expects
             vaccination during 42 day follow-up postvaccination period

          -  had a fever within 72 hours prior to study vaccination

          -  has participated in another trial within prior 30 days, is currently participating in
             another trial, or plans to participate in another trial during the planned study
             period for this trial

          -  is pregnant or nursing