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A Measles, Mumps, and Rubella Investigational Vaccine Trial
This study has been completed.
Study NCT00109278   Information provided by Merck
First Received: April 26, 2005   Last Updated: May 13, 2008   History of Changes

April 26, 2005
May 13, 2008
October 2004
May 2005   (final data collection date for primary outcome measure)
Antibody response rate to measles at 6 weeks postvaccination
Same as current
Complete list of historical versions of study NCT00109278 on ClinicalTrials.gov Archive Site
Geometric mean titers to measles by ELISA at 6 weeks postvaccination
Same as current
 
A Measles, Mumps, and Rubella Investigational Vaccine Trial
A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age

The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).

The duration of treatment is 6 weeks.

Phase II
Interventional
Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Measles
  • Biological: V205C, measles, mumps, and rubella virus vaccine live
  • Biological: Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1100
 
May 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy children 12 to 18 months of age.

Exclusion Criteria:

  • Previous receipt of measles, mumps, rubella and/or varicella vaccine.
  • Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
  • Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
  • History of seizures (convulsions)
  • Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin.
  • A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F [37.5° C]).
Both
12 Months to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00109278
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
2005_016, V205C-010
Merck
 
Study Director: Medical Monitor Unaffiliated
Merck
May 2008

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