Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)

A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process 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 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.

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.