NCT00975507

ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

Conditions

• Measles
• Mumps
• Rubella
• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live	a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
BIOLOGICAL	Comparator: Placebo	a single 0.5 mL subcutaneous placebo injection at Day 0
BIOLOGICAL	Comparator: Varivax	a single 0.5 mL subcutaneous injection of Varivax at Day 0
BIOLOGICAL	Comparator: M-M-R II	a single 0.5 mL subcutaneous injection of M-M-R II at Day 0

Timeline

• Start date: 1998-03-01
• Primary completion: 1999-01-01
• Completion: 1999-06-01
• First posted: 2009-09-11
• Last updated: 2015-10-06
• Results posted: 2010-02-10