Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
Condition: Varicella
MeSH terms: Chickenpox
Intervention: VARIVAX® PE34 Process; VARIVAX® 2016 Commercial Process; M-M-R II®
Intervention description: Varicella virus vaccine live manufactured with a new passage extension process (PE34); Varicella virus vaccine live manufactured with the 2016 commercial process; Measles, Mumps, and Rubella virus vaccine live
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 600.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella
      Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with
      the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody
      response rate and mean antibody titer induced at 6 weeks after a single vaccination by
      VARIVAX® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process,
      and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella

        Exclusion Criteria:

          -  Received any measles, mumps, rubella, or varicella vaccine at any time prior to the
             study, or is anticipated to receive any of these vaccines outside the study

          -  Any congenital or acquired immune deficiency, neoplastic disease, or depressed
             immunity

          -  Received systemic immunomodulatory steroids within 3 months prior to entering the
             study or is expected to receive them during the course of the study

          -  History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg
             proteins, chicken proteins, or any component of VARIVAX® or M-M-R II®

          -  Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting
             the bone marrow or lymphatic systems

          -  Received salicylates within 14 days prior to study vaccination

          -  Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior
             to study vaccination

          -  Received immune globulin, a blood transfusion, or blood-derived products within 5
             months prior to study vaccination

          -  History of seizure disorder, including febrile seizure

          -  Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination

          -  History of thrombocytopenia

          -  Born to a human immunodeficiency virus (HIV)-infected mother

          -  Has a diagnosis of active untreated tuberculosis

          -  Participated in any other clinical trial (other than a surveillance study) within 30
             days prior to study enrollment.