Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)

Phase 3

Completed

• Conditions: Mumps; Rubella; Varicella; Measles

• Registration Number: NCT00092430
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09-26
• Primary Completion: 2003-06-09
• Study Completion: 2003-06-09
• Study First Submitted: 2004-09-22
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Healthy children 12-23 months of age

Exclusion Criteria

• Previously had measles, mumps, rubella, or varicella
• Compromised immune system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent of patients demonstrating adequate antibody titers 6 weeks following administration

Secondary Outcome Measures

Name	Time	Method
Geometric mean titers (GMT) 6 weeks post vaccination