Maternal Immunization: Giving Immunity For Tomorrow

NCT ID: NCT01496079

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 166 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-12-31

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

Conditions

Pregnancy; Influenza

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Inactivated influenza vaccine in pregnancy

Healthy pregnant women who elect to receive inactivated influenza vaccine in early pregnancy (\< 20 weeks gestation) and their infants

No interventions assigned to this group

No inactivated influenza vaccine during pregnancy

Healthy pregnant women who decline inactivated influenza vaccine in pregnancy and their infants

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Julie Shakib

Assistant Professor of Pediatrics, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie H. Shakib, DO, MS, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

00051718

Identifier Type: -

Identifier Source: org_study_id