Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT02649192
Eligibility Criteria:
Inclusion Criteria:
* Resident of the Memphis area community.
* Parent or legal guardian willing and able to give informed consent and comply with study requirements.
Exclusion Criteria:
* Current use of investigational or immunosuppressive drugs (e.g., steroids) at the time of enrollment.
* Currently taking a daily (routine) vitamin A, D, or multivitamin. Note: participants who report occasional or sporadic vitamin use will be allowed to enroll.
* History of lung disease, asthma, immunodeficiency, sickle cell disease, or any other serious underlying condition or disease in the opinion of the principal investigator.
* Evidence of developmental delay or evolving neurological disorders at screening. Current use of antibiotics or antivirals at enrollment.
* History of having a severe allergy to eggs or to any inactive ingredient in the influenza virus vaccine
* History of a life-threatening reaction to influenza vaccinations
* Currently wheezing at the time of enrollment
* History of heart, kidney, or lung conditions
* History of diabetes
* Use of an anti-influenza medication (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment
* Acute febrile \[\>100.0°F (37.8°C) oral\] illness or acute respiratory illness (e.g., cough or sore throat) within 3 days prior to enrollment
* Previous receipt of current seasonal influenza vaccine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
8 Years
Study:
NCT02649192
Study Brief:
Protocol Section:
NCT02649192