NCT03239873

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	VARIVAX® PE34 Process	Varicella virus vaccine live manufactured with a new passage extension process (PE34)
BIOLOGICAL	VARIVAX® 2016 Commercial Process	Varicella virus vaccine live manufactured with the 2016 commercial process
BIOLOGICAL	M-M-R II®	Measles, Mumps, and Rubella virus vaccine live

Timeline

• Start date: 2017-10-17
• Primary completion: 2018-08-14
• Completion: 2019-04-02
• First posted: 2017-08-04
• Last updated: 2021-01-27
• Results posted: 2019-08-26

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated drug study