Responses of Premature Infants to Measles-Mumps-Rubella (MMR) and Varicella Vaccines

This study has been terminated.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00138255
First received: August 26, 2005
Last updated: August 26, 2010
Last verified: May 2005
  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 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 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
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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

No publications provided

ClinicalTrials.gov Identifier: NCT00138255     History of Changes
Other Study ID Numbers: 03-140
Study First Received: August 26, 2005
Last Updated: August 26, 2010
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 20, 2014