MMR and Varicella Vaccine in Premature Infants

Mumps Clinical Trial

Official title: MMR and Varicella Vaccine Responses in Extremely Premature Infants

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chickenpox
• Mumps
• Rubella
• Rubeola

• NCT number: NCT00156559
• Study type: Observational
• Source: University of Rochester
• Status: Completed
• Phase: Phase 4
• Start date: January 2004
• Completion date: May 2005