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A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age
This study is ongoing, but not recruiting participants.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00092391
  Purpose

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


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: V205C, measles, mumps, and rubella virus vaccine live
Biological: Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
Phase III

MedlinePlus related topics: Chickenpox Measles Mumps Rubella
Drug Information available for: Rubella Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Dose Comparison
Official Title: A Study of V205C at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age

Further study details as provided by Merck:

Primary Outcome Measures:
  • Neutralizing antibodies to mumps at 6 weeks postvaccination

Secondary Outcome Measures:
  • Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination.

Estimated Enrollment: 1770
Study Start Date: February 1999
Detailed Description:

The duration of treatment is 24 months.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study ID Numbers: 2004_073
Study First Received: September 22, 2004
Last Updated: June 2, 2006
ClinicalTrials.gov Identifier: NCT00092391  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Herpes Zoster
Mouth Diseases
Paramyxoviridae Infections
Measles
Chickenpox
Healthy
Rubella
Herpesviridae Infections
Virus Diseases
DNA Virus Infections
Chicken pox
Stomatognathic Diseases
Salivary Gland Diseases
Mumps

Additional relevant MeSH terms:
Parotid Diseases
RNA Virus Infections
Rubulavirus Infections
Parotitis
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 14, 2009