Maternal Immunization: Giving Immunity For Tomorrow (MI GIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496079
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Julie Shakib, 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

Condition or disease
Pregnancy Influenza

Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Immunizing Pregnant Women In Protecting Young Infants Against Influenza
Study Start Date : December 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women and their infants receiving care at University of Utah Health Sciences (UUHS) will be recruited and followed.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01496079

United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Principal Investigator: Julie H. Shakib, DO, MS, MPH University of Utah

Responsible Party: Julie Shakib, Assistant Professor of Pediatrics, Principal Investigator, University of Utah Identifier: NCT01496079     History of Changes
Other Study ID Numbers: 00051718
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Julie Shakib, University of Utah:
Maternal immunization
Infant immunization
Influenza vaccine
Passive transfer of immunity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs