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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 has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092391
First received: September 22, 2004
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  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: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Neutralizing antibodies to mumps at 6 weeks postvaccination [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination [ Time Frame: 6 weeks and 1 year postvaccination ] [ Designated as safety issue: No ]

Enrollment: 1997
Study Start Date: February 1999
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
M-M-R(TM) II at current release potency
 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
Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0
Experimental: Mumps Expiry Group 1
M-M-R(TM) II at intermediate expiry potency
 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
Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0
Experimental: Mumps Expiry Group 2
M-M-R(TM) II at expiry potency
 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
Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092391

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092391     History of Changes
Other Study ID Numbers: 2004_073, V205C-007
Study First Received: September 22, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Parotitis
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
 Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013