Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Intervention: MMRV (AMP); MMRV (2006 process)
Intervention description: Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.; Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1412.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare the safety, tolerability, and immunogenicity of measles, mumps,
      rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with
      those of the 2006 process
    

Eligibility criteria:

        Inclusion Criteria:

          -  Negative clinical history for measles, mumps, rubella, varicella, and zoster

        Exclusion Criteria:

          -  Received any measles, mumps, rubella, or varicella vaccine, either alone or in any
             combination at any time prior to the study, or is anticipated to receive any of these
             vaccines outside of study protocol, either alone or in any combination, during the
             study

          -  Received immune globulin, a blood transfusion or blood-derived products (does not
             include autologous blood/blood products) within 5 months (150 days) prior to any dose
             of the study vaccines or plans to receive these products while enrolled in this study

          -  Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the
             study vaccination

          -  Any congenital or acquired immune deficiency, neoplastic disease, or depressed
             immunity, including that resulting from steroid use or other immunosuppressive therapy

          -  Received 1) systemic immunomodulatory steroids [greater than the

        equivalent of 2 mg/kg total daily dose of prednisone] within 3 months prior to

        entering the study, or 2) any dose of systemic immunomodulatory steroids within

        7 days prior to entering study, or 3) is expected to require systemic immunomodulatory
        steroids through the course of the study

          -  History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg
             proteins (eggs or egg products), chicken proteins, or any component of the study
             vaccines

          -  Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior
             to study vaccination

          -  Diagnosis of an active neurological disorder. Enrollment may be considered

        when the disease process has been stabilized

          -  History of seizure disorder, including single febrile seizure

          -  Diagnosis of active untreated tuberculosis

          -  History of thrombocytopenia

          -  Born to a human immunodeficiency virus (HIV) infected mother