Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)



Status:Completed
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:2/7/2015
Start Date:March 2014
End Date:October 2015
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 Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II

This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella
Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™
2007 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™ NSP are
non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate
induced by VARIVAX™ NSP is acceptable.


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™

- 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

- Participated in any other clinical trial (other than a surveillance study) within 30
days prior to study enrollment.
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