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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092430
First received: September 22, 2004
Last updated: January 21, 2010
Last verified: January 2010

September 22, 2004
January 21, 2010
September 2002
Not Provided
Percent of patients demonstrating adequate antibody titers 6 weeks following administration
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Complete list of historical versions of study NCT00092430 on ClinicalTrials.gov Archive Site
Geometric mean titers (GMT) 6 weeks post vaccination
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Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine
A Comparison of the Safety, Tolerability, and Immunogenicity of a Refrigerator-Stable Measles, Mumps, Rubella, and Varicella Combination Vaccine V221 (Refrigerated) Versus V221 (Frozen) in Healthy Children

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Measles
  • Mumps
  • Rubella
  • Varicella
Biological: V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
May 2003
Not Provided

Inclusion Criteria:

  • Healthy children 12-23 months of age

Exclusion Criteria:

  • Previously had measles, mumps, rubella, or varicella
  • Compromised immune system
Both
12 Months to 23 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00092430
2004_076
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP