Trial record 6 of 102 for:
A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
This study has been completed.
Information provided by (Responsible Party):
First received: April 26, 2005
Last updated: October 30, 2013
Last verified: October 2013
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).
Biological: V205C, measles, mumps, and rubella virus vaccine live
Biological: Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
||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
Primary Outcome Measures:
- Antibody response rate to measles at 6 weeks postvaccination
Secondary Outcome Measures:
- Geometric mean titers to measles by ELISA at 6 weeks postvaccination
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2005 (Final data collection date for primary outcome measure)
The duration of treatment is 6 weeks.
|Ages Eligible for Study:
||12 Months to 18 Months
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Healthy children 12 to 18 months of age.
- 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]).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109278
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 26, 2005
||October 30, 2013
||United States: Food and Drug Administration
Keywords provided by Merck:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2013
RNA Virus Infections