Status:
COMPLETED
MMR and Varicella Vaccine in Premature Infants
Lead Sponsor:
University of Rochester
Conditions:
Chickenpox
Rubella
Eligibility:
All Genders
12-16 years
Brief Summary
This research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure...
Detailed Description
Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants Phase: IV Population: 16 generally healthy premature infants born at \< 29 weeks' gestation, \< 16 months old from the Roche...
Eligibility Criteria
Inclusion
- Subjects must meet all of the inclusion criteria to participate in this study.
- Premature infant \< 29 weeks' gestation at birth or term infant \>/= 37 weeks' gestation at birth.
- Postnatal age \< 16 months, 0 days.
- Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)
- Parental permission.
- Agreement of primary care pediatrician/ health care provider.
- Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
- Healthy status at enrollment.
Exclusion
- Known immunodeficiency.
- Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
- Requiring oxygen therapy.
- Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
- Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
OBSERVATIONAL
End Date :
May 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00156559
Start Date
January 1 2004
End Date
May 1 2005
Last Update
September 17 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester
Rochester, New York, United States, 14642