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Maternal Immunization: Giving Immunity For Tomorrow (MI GIFT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Shakib, University of Utah
ClinicalTrials.gov Identifier:
NCT01496079
First received: November 28, 2011
Last updated: April 12, 2017
Last verified: April 2017

November 28, 2011
April 12, 2017
December 2011
December 2015   (Final data collection date for primary outcome measure)
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
  • Influenza antibody titer levels in infants born to women who receive trivalent inactivated influenza vaccine in early pregnancy compared to late pregnancy [ Time Frame: Infant antibody titers at birth ]
    Influenza titers will be measured by on infant serum samples by hemagluttination inhibition assay.
  • Influenza antibody titer levels in infants born to women who receive trivalent inactivated influenza vaccine in early pregnancy compared to late pregnancy [ Time Frame: Infant antibody titers at 2 months ]
    Influenza titers will be measured by on infant serum samples by hemagluttination inhibition assay.
  • Influenza antibody titer levels in infants born to women who receive trivalent inactivated influenza vaccine in early pregnancy compared to late pregnancy [ Time Frame: Infant antibody titers at 6 months ]
    Influenza titers will be measured by on infant serum samples by hemagluttination inhibition assay.
Complete list of historical versions of study NCT01496079 on ClinicalTrials.gov Archive Site
Not Provided
Proportion of infants achieving seroconversion following active immunization with trivalent inactivated influenza vaccine [ Time Frame: Infant antibody titers at 6, 7, and 8 months of age ]
Influenza titers will be measured by on infant serum samples by hemagluttination inhibition assay.
Not Provided
Not Provided
 
Maternal Immunization: Giving Immunity For Tomorrow
The Role of Immunizing Pregnant Women In Protecting Young Infants Against Influenza

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Pregnant women and their infants receiving care at University of Utah Health Sciences (UUHS) will be recruited and followed.
  • Pregnancy
  • Influenza
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01496079
00051718
No
Not Provided
Not Provided
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Julie Shakib, University of Utah
University of Utah
Not Provided
Principal Investigator: Julie H. Shakib, DO, MS, MPH University of Utah
University of Utah
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP