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Rochester, New York 14642

  • Mumps

Purpose:

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.


Study summary:

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 Rochester area 16 generally healthy full-term infants born at >/= 37 weeks' gestation, < 16 months old from the Rochester area Number of Sites: University of Rochester Study Duration: 1.5 - 8.5 months Description of Agent or Intervention: Subjects will make 2 study visits. The first, at 15 months of age, will coincide with a routine well child visit. Subjects will have 2 mL of blood drawn at the time of their routine, 15-month MMR, varicella, and pneumococcal conjugate immunizations. At a second study visit 4-6 weeks later, another 2 mL of blood will be drawn. Objectives: Primary: We propose to measure the immunogenicity of routinely administered varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29 weeks gestation (premature), when compared to that in full-term infants. Measles titers will be measured by neutralization assay. Mumps and rubella titers will be measured by enzyme-linked florescent immunoassay. Varicella titers will be measured by enzyme linked immunosorbent assay. Safety will be assessed by parental recall of vaccine-related adverse events and by active, prospective collection of blood-draw-associated adverse events. Schematic of Study Design: Subjects will be approached at 9-12 months of age for inclusion, and will consent at this time or at Visit 1 Visit 1 (15 mos): Preterm N = 16, Full term N = 16, 2 ml blood draw Routine MMR, varicella vaccines administered by primary pediatrician per standard of care (at Visit 1) Visit 2 (16 mos): Preterm N = 16, Full term N = 16, 2 ml blood draw Varicella, mumps, measles and rubella vaccine titers measured by ELISA


Criteria:

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.


NCT ID:

NCT00156559


Primary Contact:

Principal Investigator
Carl T. D'Angio, MD
University of Rochester


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: March 26, 2020

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