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

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ClinicalTrials.gov Identifier: NCT00138255
Recruitment Status : Terminated
First Posted : August 30, 2005
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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 or disease
Measles Mumps Rubella Varicella

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).

Study Type : Observational
Enrollment : 32 participants
Time Perspective: Prospective
Official Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants
Study Start Date : June 2004
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources





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Ages Eligible for Study:   up to 16 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138255


Locations
United States, New York
University of Rochester School of Medicine and Dentistry
Rochester, New York, United States, 14642
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier: NCT00138255     History of Changes
Other Study ID Numbers: 03-140
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: May 2005

Additional relevant MeSH terms:
Measles
Chickenpox
Herpes Zoster
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections