Maternal Immunization: Giving Immunity For Tomorrow

Study Overview
=================
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

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

Conditions
-----------------
Pregnancy, Influenza

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inactivated influenza vaccine in pregnancy<br>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<br>Healthy pregnant women who decline inactivated influenza vaccine in pregnancy and their infants | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maternal immunization, Infant immunization, Influenza vaccine, Passive transfer of immunity