Mumps Clinical Trial
Official title:
MMR and Varicella Vaccine Responses in Extremely Premature Infants
Verified date | September 2015 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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 the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29 weeks gestation, when compared to full-term infants, as measured by the relevant viral serologies.
Status | Completed |
Enrollment | 32 |
Est. completion date | May 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Months to 16 Months |
Eligibility |
Inclusion Criteria: Subjects must meet all of the inclusion criteria to participate in this study. 1. Premature infant < 29 weeks' gestation at birth or term infant >/= 37 weeks' gestation at birth. 2. Postnatal age < 16 months, 0 days. 3. 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.) 4. Parental permission. 5. Agreement of primary care pediatrician/ health care provider. 6. Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester. 7. Healthy status at enrollment. Exclusion Criteria: 1. Known immunodeficiency. 2. Systemic corticosteroid therapy at the time of MMR/varicella vaccination. 3. Requiring oxygen therapy. 4. Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion. 5. Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
D'Angio CT, Boohene PA, Mowrer A, Audet S, Menegus MA, Schmid DS, Beeler JA. Measles-mumps-rubella and varicella vaccine responses in extremely preterm infants. Pediatrics. 2007 Mar;119(3):e574-9. — View Citation
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