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Sponsored by: |
University of Rochester |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00156559 |
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 Type: | Observational |
Study Design: | Prospective |
Official Title: | MMR and Varicella Vaccine Responses in Extremely Premature Infants |
Estimated Enrollment: | 32 |
Study Start Date: | January 2004 |
Study Completion Date: | May 2005 |
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
Ages Eligible for Study: | 12 Months to 16 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects must meet all of the inclusion criteria to participate in this study.
Exclusion Criteria:
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Carl T. D'Angio, MD | University of Rochester |
Study ID Numbers: | DMID 03-140, N01-AI-25460 |
Study First Received: | September 8, 2005 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00156559 History of Changes |
Health Authority: | United States: Institutional Review Board |
immunization vaccine low birth weight infant premature infant |
Virus Diseases Body Weight Birth Weight Herpes Zoster Paramyxoviridae Infections Measles |
Chickenpox DNA Virus Infections Rubella Mumps Herpesviridae Infections |
Virus Diseases RNA Virus Infections Paramyxoviridae Infections Morbillivirus Infections Measles |
Chickenpox DNA Virus Infections Mononegavirales Infections Herpesviridae Infections |