CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 600 enrolled
Drug / intervention
VARIVAX® PE34 Process +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03239873
NCT03239873Phase 3Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Aug 4, 2017·Updated Jan 27, 2021

In Brief

A Phase 3 clinical trial evaluating VARIVAX® PE34 Process, VARIVAX® 2016 Commercial Process, and 1 other intervention for Varicella. Completed, enrolled 600 participants across 37 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricella
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 4, 2017
Enrollment StartOct 17, 2017
Primary CompletionAug 14, 2018
Study CompletionApr 2, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.9 years ago

Interventions

VARIVAX® PE34 Processbiological

Varicella virus vaccine live manufactured with a new passage extension process (PE34)

VARIVAX® 2016 Commercial Processbiological

Varicella virus vaccine live manufactured with the 2016 commercial process

M-M-R II®biological

Measles, Mumps, and Rubella virus vaccine live