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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436184
• Other study ID #: 1U01AI144673-01
• Secondary ID: 1U01AI144673-01
• Status: Recruiting
• Start date: October 17, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Nancy Back, RN,MPH
• Phone: 513-636-2479
• Email: Nancy.Back[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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