Status:
COMPLETED
Ontogeny of Measles Immunity in Infants
Lead Sponsor:
Stanford University
Conditions:
Measles
Eligibility:
All Genders
6+ years
Brief Summary
This is an immunogenicity study evaluating the development of the immune response of healthy infants following primary vaccination with Attenuvax at 6 or 9 months of age compared with responses in 12 ...
Detailed Description
This is an open-label immunogenicity and safety study of live attenuated Measles Vaccine (Attenuvax) and Measles-Mumps-Rubella (MMR-II) vaccine administered to healthy children at 6 (n=70), 9 (n=70), ...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following criteria in order to be enrolled:
- Healthy infants 6, 9, or 12 months (+ 3 weeks) of age
- Free of obvious health problems as established by medical history and clinical examination before entering into the study
- Parent/legal guardian willing and capable of signing written informed consent
- Parent/legal guardian expected to be available for entire study
- Parent/legal guardian can be reached by telephone
Exclusion
- All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Former premature infants (\<36 weeks)
- Birth weight \< 2500grams
- Significant underlying chronic illness
- Immunodeficiency disease or immunosuppressive therapy in the participant
- Any other condition which in the clinical judgment of the investigator might interfere with vaccine evaluation
- Allergy to any components of the vaccine, including anaphylaxis or anyphalaxoid reaction to neomycin or eggs
- Administration of an investigational drug
- Blood products within 3 months of initial enrollment
- Current febrile respiratory illness or other active febrile infection
- Family history of congenital/hereditary immunodeficiency, unless immune competence of subject has been determined.
- Blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the bone marrow or lymphatic systems.
Key Trial Info
Start Date :
July 1 1993
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00240916
Start Date
July 1 1993
End Date
July 1 2013
Last Update
June 9 2022
Active Locations (2)
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1
Palo Alto Medical Foundation/Department of Pediatrics
Palo Alto, California, United States, 94301
2
Stanford University School of Medicine
Stanford, California, United States, 94305