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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00138255 |
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.
Study Type: | Observational |
Study Design: | Screening, Cross-Sectional, Defined Population, Prospective Study |
Official Title: | MMR and Varicella Vaccine Responses in Extremely Premature Infants |
Estimated Enrollment: | 32 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | June 2005 |
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).
Ages Eligible for Study: | up to 16 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Rubivirus Infections Parotid Diseases RNA Virus Infections Morbillivirus Infections |
Rubulavirus Infections Parotitis Mononegavirales Infections |