NCT00156559

MMR and Varicella Vaccine in Premature Infants

MMR and Varicella Vaccine Responses in Extremely Premature Infants

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (planned)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 12 Months – 16 Months
• Healthy volunteers: Accepted

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

Conditions

• Chickenpox
• Rubella
• Rubeola
• Mumps

Timeline

• Start date: 2004-01-01
• Completion: 2005-05-01
• First posted: 2005-09-12
• Last updated: 2015-09-17

Locations

1 site across 1 country: United States