Expired Study
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Rochester, New York 14642


Purpose:

The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison.


Study summary:

The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison. Extremely premature infants (born at <28-30 weeks gestation) have lower antibody responses than full-term infants to several vaccines given at the postnatal ages recommended for full term infants. We propose to evaluate the immunogenicity of varicella and mumps-measles-rubella (MMR) vaccines in relatively healthy 15 month-old children born at <29 weeks gestation. This is a phase IV, observational study with 2 study arms having 16 infants each. The first group will enroll infants 9-12 months old that were born premature (<29 weeks gestation). The second group will be matched for sex, race, and postnatal age, but will have been full term (>= 37 weeks gestation) at birth. Infants will be vaccinated at visit 1 and post-vaccine serology will drawn at visit 2 (4 to 6 weeks after visit 1).


Criteria:

Inclusion Criteria: 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.


NCT ID:

NCT00138255


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Rochester, New York 14642
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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