Maternal Immunization: Giving Immunity For Tomorrow

Pregnancy Clinical Trial

— MI GIFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496079
• Other study ID #: 00051718
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: April 12, 2017
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Pregnancy

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza antibody titer levels in infants born to women who receive inactivated influenza vaccine in early pregnancy compared with late pregnancy and no immunization	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	Infant antibody titers at delivery