Status:
TERMINATED
Immune Responses to Two Dose Varivax +/- MMR-II
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Measles
Mumps
Eligibility:
All Genders
12-12 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will test the safety and how well the body's immune system responds to a live, but weakened varicella (chickenpox) vaccine, known as Varivax, given with and without ProQuad, another measles...
Detailed Description
This clinical trial is a phase I/II exploratory immunogenicity and safety study of live attenuated Varicella (Varivax), Measles-Mumps-Rubella (MMR-II), or combination Varicella/Measles, Mumps/Rubella ...
Eligibility Criteria
Inclusion
- Healthy infants 12 months (+ 4 weeks) of age.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study. This includes all chronic health problems and immunodeficiencies.
- Parent/legal guardian has provided signed, written informed consent.
- Parent/legal guardian expected to be available for entire study.
- Parent/legal guardian can be reached by telephone.
Exclusion
- Former premature infants (\<36 weeks).
- Birth weight \< 2500 grams.
- Significant underlying chronic illness.
- Immunodeficiency disease or use of immunosuppressive therapy by the participant.
- Any other condition that in the clinical judgment of the investigator might interfere with vaccine evaluation.
- Allergy to any components of the vaccine, including anaphylaxis or anaphylaxoid reaction to neomycin or eggs for MMR-II, and/or hypersensitivity to gelatin and anaphylaxis or anaphylaxoid reaction to neomycin for Varivax.
- Plans for participation in another clinical trial with an investigational drug or vaccine for the duration of this study.
- Blood products within 3 months prior to initial enrollment.
- Previous receipt of MMR and Varivax or ProQuad.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00258726
Start Date
October 1 2005
End Date
July 1 2007
Last Update
August 27 2010
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305