Status:
ACTIVE_NOT_RECRUITING
Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
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 infe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05436184
Start Date
October 17 2019
End Date
December 31 2028
Last Update
November 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45219