A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
Phase 2
Completed
- Conditions
- Measles
- Registration Number
- NCT00109278
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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).
- Detailed Description
The duration of treatment is 6 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1100
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]).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Antibody response rate to measles at 6 weeks postvaccination
- Secondary Outcome Measures
Name Time Method Geometric mean titers to measles by ELISA at 6 weeks postvaccination