NCT00109343

V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)

An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V221 Given Concomitantly With Pneumococcal Conjugate Vaccine in Healthy Children 12 to 15 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,027 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

Summary

The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.

Conditions

• Measles
• Mumps
• Rubella
• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Comparator: ProQuad™ (V221)	0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
BIOLOGICAL	Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)	0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2005-04-27
• Last updated: 2017-04-12
• Results posted: 2010-02-10