NCT01626794

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)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	VARIVAX™ VEP	Two 0.5 mL subcutaneous doses administered on Days 1 and 91
BIOLOGICAL	VARIVAX™ 2007 Process	Two 0.5 mL subcutaneous doses administered on Days 1 and 91
BIOLOGICAL	M-M-R™ II	Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-06-25
• Last updated: 2015-01-27