Maternal Immunization: Giving Immunity For Tomorrow

Completed

• Conditions: Pregnancy; Influenza

• Registration Number: NCT01496079
• Lead Sponsor: University of Utah

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-28
• Study Start: 2011-12
• Study First Submitted QC: 2011-12-17
• Study First Posted: 2011-12-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Utah Health Sciences Center; 🇺🇸 Salt Lake City, Utah, United States