Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027 AM1)



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:3/30/2013
Start Date:June 2012
End Date:February 2014
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)


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


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
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