NCT00986232

ProQuad Dose Selection Study (V221-011)(COMPLETED)

A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,551 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

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 ProQuad (low, middle, or high dose) at Day 0 and Day 90
BIOLOGICAL	Comparator: M-M-R II	A single 0.5 mL subcutaneous injection at Day 0
BIOLOGICAL	Comparator: PUVV	A single 0.5 mL subcutaneous injection at Day 0

Timeline

• Start date: 1999-04-01
• Primary completion: 2000-04-01
• Completion: 2000-09-01
• First posted: 2009-09-29
• Last updated: 2015-04-10
• Results posted: 2010-02-15