MMR and Varicella Vaccine in Premature Infants
- Conditions
- RubellaChickenpoxRubeolaMumps
- Registration Number
- NCT00156559
- Lead Sponsor
- University of Rochester
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Subjects must meet all of the inclusion criteria to participate in this study.
- Premature infant < 29 weeks' gestation at birth or term infant >/= 37 weeks' gestation at birth.
- Postnatal age < 16 months, 0 days.
- 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.)
- Parental permission.
- Agreement of primary care pediatrician/ health care provider.
- Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
- Healthy status at enrollment.
- Known immunodeficiency.
- Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
- Requiring oxygen therapy.
- Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
- Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Rochester
🇺🇸Rochester, New York, United States