A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)

A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX Made With the Varicella Enhanced Process (VEP)

This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.

Inclusion Criteria:

• negative clinical history of measles, mumps, rubella, varicella, and zoster

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 require them throughout the study
• history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of M-M-R™ II or VARIVAX™
• received salicylates within 14 days prior to study vaccination
• exposed to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to study vaccination
• received any non-live vaccine within 14 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
• received any live vaccine within 30 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
• received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to any study vaccination
• fever illness (≥102.2°F [39.0°C]) within 72 hours prior to study vaccination
• 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