NCT00985153

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

Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,927 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

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.

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 at Day 0
BIOLOGICAL	Comparator: Varivax	A Single 0.5 mL subcutaneous injection at Day 0
BIOLOGICAL	Comparator: M-M-R II	A Single 0.5 mL subcutaneous injection at Day 0

Timeline

• Start date: 2000-03-01
• Primary completion: 2001-05-01
• Completion: 2001-05-01
• First posted: 2009-09-28
• Last updated: 2015-11-23
• Results posted: 2010-02-09