Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants

Study Overview
=================
Brief Summary
-----------------
The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures

Detailed Description
-----------------
Vaccination is a leading public health intervention for reducing morbidity and mortality from influenza worldwide. Vaccine optimization is hampered by lack of understanding the natural history of infection and immunity, including the full complement of maternal immunity imparted to infants. This gap in understanding can be addressed only through a well-designed birth cohort study. Up to 1500 mother-infant pairs will be enrolled at or after week 34 in pregnancy over three flu seasons, up to four years of age depending on birth month, at two sites. Follow-up will occur from the third trimester until the child is three to four years of age, along with medical records review to ascertain outcomes not captured through weekly illness and respiratory surveillance, and medical record review up to 18 years of age. The primary aim is to rigorously document the natural history of infection and immune response to influenza in study infants for at least three entire flu seasons.

Official Title
-----------------
Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants

Conditions
-----------------
Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother pregnant and ≥ 34 weeks gestation and ≥ 18 yrs. of age Plans to deliver at local hospital Lives within designated home zip codes: No plans to move outside study area within study timeframe Cell phone that can be used for text messaging Singleton live born infant, born ≥ 34 weeks gestational age (GA) Exclusion Criteria: Fetal or infant death prior to maternal hospital discharge Mother known to be infected with HIV based on medical records Major congenital anomalies, prenatally diagnosed or other major disorder or anomaly as determined by the PI Reported use of heroin, cocaine or methamphetamines during pregnancy Adoptive infant Enrolled in any investigational vaccine trial or other interventional randomized, clinical trial involving the mother or infant that the PI's deem to be in conflict with study outcomes
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cincinnati IMPRINT birth cohort<br>mother-infant pairs enrolled at or after week 34 in pregnancy and followed over three flu seasons, up to four years of age. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response to influenza virus infection | Evaluate the immune response to influenza virus infections due to various subtypes in healthy children from birth to 4 years of age in a maternal-infant birth cohort | 4 years | 
| Immune response to influenza vaccination | Evaluate the immune response to influenza vaccination in healthy children from 6 months to 4 years of age in a maternal-infant birth cohort | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, birth cohort