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

Measles Clinical Trial

Official title:

A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092391
• Other study ID #: V205C-007
• Secondary ID: 2004_073
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: October 22, 2015
• Start date: February 1999
• Est. completion date: July 2001

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1997
• Est. completion date: July 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 18 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
• Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutralizing antibodies to mumps at 6 weeks postvaccination		6 weeks postvaccination	No
Secondary	Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination		6 weeks and 1 year postvaccination	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site