MMR and Varicella Vaccine in Premature Infants

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00156559
First received: September 8, 2005
Last updated: June 12, 2008
Last verified: September 2005
  Purpose

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.


Condition Phase
Chickenpox
Rubella
Rubeola
Mumps
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Estimated Enrollment: 32
Study Start Date: January 2004
Study Completion Date: May 2005
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

  Eligibility

Ages Eligible for Study:   12 Months to 16 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must meet all of the inclusion criteria to participate in this study.

  1. Premature infant < 29 weeks' gestation at birth or term infant >/= 37 weeks' gestation at birth.
  2. Postnatal age < 16 months, 0 days.
  3. 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.)
  4. Parental permission.
  5. Agreement of primary care pediatrician/ health care provider.
  6. Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
  7. Healthy status at enrollment.

Exclusion Criteria:

  1. Known immunodeficiency.
  2. Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
  3. Requiring oxygen therapy.
  4. Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
  5. Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156559

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Carl T. D'Angio, MD University of Rochester
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00156559     History of Changes
Other Study ID Numbers: DMID 03-140, N01-AI-25460
Study First Received: September 8, 2005
Last Updated: June 12, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
immunization
vaccine
low birth weight infant
premature infant

Additional relevant MeSH terms:
Chickenpox
Measles
Mumps
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014