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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process
Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL
Time frame: Six weeks (43 days) after vaccination 1
Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)
Time frame: Days 1 to 42 after each vaccination
Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms
Time frame: Days 1 to 42 after each vaccination
Percent of participants with injection-site reactions
Time frame: Days 1 to 5 after each vaccination
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