A Measles, Mumps, and Rubella Investigational Vaccine Trial
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Measles
Intervention: V205C, measles, mumps, and rubella virus vaccine live (Biological); Comparator: Measles, Mumps, and Rubella Virus Vaccine Live (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Unaffiliated
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).
Clinical Details
Official title: 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
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Antibody response rate to measles at 6 weeks postvaccination
Secondary outcome: Geometric mean titers to measles by ELISA at 6 weeks postvaccination
Detailed description:
The duration of treatment is 6 weeks.
Eligibility
Minimum age: 12 Months.
Maximum age: 18 Months.
Gender(s): Both.
Criteria:
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]).
Locations and Contacts
Additional Information
Starting date: October 2004
Last updated: May 13, 2008
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