CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 611 enrolled
Drug / intervention
VARIVAX™ New Seed 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/NCT02062502
NCT02062502Phase 3Completed
CompareCT.gov

A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II

Merck Sharp & Dohme LLC·interventional·Posted Feb 13, 2014·Updated Oct 30, 2018

In Brief

A Phase 3 clinical trial evaluating VARIVAX™ New Seed Process, VARIVAX™ 2007 process, and 1 other intervention for Varicella. Completed, enrolled 611 participants.

Detailed Summary

This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 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™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricella
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2014
Enrollment StartMar 7, 2014
Primary CompletionFeb 24, 2015
Study CompletionOct 13, 2015
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 12.4 years ago

Interventions

VARIVAX™ New Seed Processbiological

Varicella virus vaccine live manufactured with a new seed process

VARIVAX™ 2007 processbiological

Varicella virus vaccine live manufactured with the 2007 process

M-M-R II™biological

Measles, Mumps, and Rubella virus vaccine live