CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,412 enrolled
Drug / intervention
MMRV (AMP) +1 morebiological
Likely dose
MMRV (AMP) 0.5 mLfrom 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/NCT01536405
NCT01536405Phase 3Completed
CompareCT.gov

A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)

Merck Sharp & Dohme LLC·interventional·Posted Feb 22, 2012·Updated Oct 31, 2018

In Brief

A Phase 3 clinical trial evaluating MMRV (AMP) and MMRV (2006 process) for Measles and 3 related conditions. Completed, enrolled 1,412 participants.

Detailed Summary

This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeasles, Mumps, Rubella, Varicella
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2012
Enrollment StartJun 5, 2012
Primary CompletionJul 2, 2013
Study CompletionJan 27, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.4 years ago

Interventions

MMRV (AMP)biological

Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.

MMRV (2006 process)biological

Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.