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Responses of Premature Infants to Measles-Mumps-Rubella (MMR) and Varicella Vaccines
This study has been terminated.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00138255
  Purpose

The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison.


Condition Phase
Measles
Mumps
Rubella
Varicella
Phase IV

MedlinePlus related topics: Chickenpox Measles Mumps Premature Babies Rubella Shingles
Drug Information available for: Chickenpox Vaccine
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 32
Study Start Date: June 2004
Estimated Study Completion Date: June 2005
Detailed Description:

The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison. Extremely premature infants (born at <28-30 weeks gestation) have lower antibody responses than full-term infants to several vaccines given at the postnatal ages recommended for full term infants. We propose to evaluate the immunogenicity of varicella and mumps-measles-rubella (MMR) vaccines in relatively healthy 15 month-old children born at <29 weeks gestation. This is a phase IV, observational study with 2 study arms having 16 infants each. The first group will enroll infants 9-12 months old that were born premature (<29 weeks gestation). The second group will be matched for sex, race, and postnatal age, but will have been full term (>= 37 weeks gestation) at birth. Infants will be vaccinated at visit 1 and post-vaccine serology will drawn at visit 2 (4 to 6 weeks after visit 1).

  Eligibility

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

Inclusion Criteria:

  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: NCT00138255

Locations
United States, New York
University of Rochester School of Medicine and Dentistry
Rochester, New York, United States, 14642
Sponsors and Collaborators
  More Information

Study ID Numbers: 03-140
Study First Received: August 26, 2005
Last Updated: December 15, 2005
ClinicalTrials.gov Identifier: NCT00138255  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Herpes Zoster
Mouth Diseases
Paramyxoviridae Infections
Measles
Chickenpox
Rubella
Togaviridae Infections
Herpesviridae Infections
Virus Diseases
DNA Virus Infections
Chicken pox
Stomatognathic Diseases
Salivary Gland Diseases
Mumps

Additional relevant MeSH terms:
Rubivirus Infections
Parotid Diseases
RNA Virus Infections
Morbillivirus Infections
Rubulavirus Infections
Parotitis
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 16, 2009