The Role of Immunizing Pregnant Women In Protecting Young Infants Against Influenza

University of Utah1 site in 1 country166 target enrollmentDecember 2011

ConditionsPregnancy Influenza

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pregnancy
Sponsor: University of Utah
Enrollment: 166
Locations: 1
Primary Endpoint: Influenza antibody titer levels in infants born to women who receive inactivated influenza vaccine in early pregnancy compared with late pregnancy and no immunization
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 pregnancy, late pregnancy, or no influenza immunization during pregnancy and their infants

Study hypotheses are that infants born to pregnant women who receive influenza immunization in late pregnancy will have

higher levels and a longer serum influenza antibody duration in sera (hemagglutination inhibition (HAI) titers) and colostrum/breast milk (influenza-specific IgA and IgG by enzyme-linked immunosorbent assay (ELISA) than infants of women immunized in early pregnancy or not immunized

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

December 2015

Last Updated

9 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

University of Utah

Responsible Party

Principal Investigator

Julie Shakib

Assistant Professor of Pediatrics, Principal Investigator

University of Utah

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

Influenza antibody titer levels in infants born to women who receive inactivated influenza vaccine in early pregnancy compared with late pregnancy and no immunization

Time Frame: Infant antibody titers at delivery

Influenza titers will be measured on infant serum and breast milk samples by HAI assay and on maternal colostrum or breast milk if available by ELISA and neutralization assay