Status:
COMPLETED
Maternal Immunization: Giving Immunity For Tomorrow
Lead Sponsor:
University of Utah
Conditions:
Pregnancy
Influenza
Eligibility:
FEMALE
18-45 years
Brief Summary
Study objectives are to compare * influenza antibody levels in infant sera and maternal colostrum or breast milk at delivery, 2, and 6 months women who receive influenza immunization in early pregnan...
Eligibility Criteria
Inclusion
- Pregnant women 18-45 years of age from 8-36 weeks gestation in good health as determined by medical history and recent physical exam who
- receive prenatal care at the UUHS Obstetrics and Gynecology Clinics and their infants
- plan to seek care for their infant at the UUHS affiliated Pediatric Clinics (UUHS or SMC Pediatric Clinics)
- plan for their infant to receive influenza immunization at 6 and 7 months of age
Exclusion
- maternal history of either a congenital or acquired immunodeficiency including infection (e.g. HIV), chronic steroid use, or malignancy
- serious underlying neurological, cardiac, renal, or pulmonary disease in either the mother or infant
- multiple gestation
- antenatal or postnatal detection at delivery of any major birth defect in the infant
- delivery of the infant before 37 weeks
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01496079
Start Date
December 1 2011
End Date
December 1 2015
Last Update
April 14 2017
Active Locations (1)
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1
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84108