A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

Phase 3 Completed 801 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindPrevention

Summary

The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.

Timeline

Start: 2000-08
Primary completion: 2002-05
Completion: 2003-05

Outcome

Met primary endpoint

paper Similarity (noninferiority) was demonstrated in postvaccination antibody responses to measles, mumps, and rubella between recipients of ProQuad and all recipients of M-M-RII and in responses to varicella between recipients of ProQuad and recipients of Varivax. PMID 16452343 ↗

Publications

Results Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schodel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. 2006 Feb;117(2):265-72. doi: 10.1542/peds.2005-0092.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	M-M-R II	Vaccine	0.5 ml	Subcutaneous
Subject	ProQuad	Vaccine	0.5 ml	Subcutaneous
Comparator	Varivax	Vaccine	0.5 ml	Subcutaneous