Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

Phase 3 Completed 3927 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindPrevention

Summary

This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.

Timeline

Start: 2000-03
Primary completion: 2001-05
Completion: 2001-05

Publications

Results Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schodel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J. 2006 Jul;25(7):615-22. doi: 10.1097/01.inf.0000220209.35074.0b.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	M-M-R II	Vaccine	0.5 ml	Subcutaneous
Subject	Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live	Vaccine	0.5 ml	Subcutaneous
Comparator	Varivax	Vaccine	0.5 ml	Subcutaneous

Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

Summary

Timeline

Publications

Drugs

Indications