A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)

Phase 3

Completed

• Conditions: Varicella; Measles; Mumps; Rubella

• Registration Number: NCT00092391
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-02
• Primary Completion: 2001-07
• Study Completion: 2001-07
• Study First Submitted: 2004-09-22
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1997

Inclusion Criteria

• Healthy children 12 to 18 months of age

Exclusion Criteria

• History or prior exposure to measles, mumps, rubella or varicella
• History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Neutralizing antibodies to mumps at 6 weeks postvaccination	6 weeks postvaccination

Secondary Outcome Measures

Name	Time	Method
Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination	6 weeks and 1 year postvaccination