Maternal Immunization: Giving Immunity For Tomorrow

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01496079

Acronym

MI GIFT

Enrollment

166

Registered

2011-12-21

Start date

2011-12-31

Completion date

2015-12-31

Last updated

2017-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Pregnancy

Keywords

Maternal immunization, Infant immunization, Influenza vaccine, Passive transfer of immunity

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results