Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092430
First received: September 22, 2004
Last updated: January 23, 2015
Last verified: January 2015

September 22, 2004
January 23, 2015
September 2002
June 2003   (final data collection date for primary outcome measure)
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 (V221-016)
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
June 2003
June 2003   (final data collection date for primary outcome measure)

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   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00092430
V221-016, 2004_076
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2015

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