Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

Phase 3 Completed 1412 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupQuadruple-blindPrevention

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

Timeline

Start: 2012-06-05
Primary completion: 2013-07-02
Completion: 2014-01-27

Publications

Results Marshall GS, Senders SD, Shepard J, Twiggs JD, Gardner J, Hille D, Hartzel J, Valenzuela R, Stek JE, Helmond FA. A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process. Hum Vaccin Immunother. 2016 Aug 2;12(8):2188-2196. doi: 10.1080/21645515.2016.1165374. Epub 2016 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MMRVAMP	Vaccine	0.5 ml	Subcutaneous
Comparator	ProQuad	Vaccine	0.5 ml	Subcutaneous

Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

Summary

Timeline

Publications

Drugs

Indications