Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT00156559
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 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.
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 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
Study:
NCT00156559
Study Brief:
Protocol Section:
NCT00156559