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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT02559505
Eligibility Criteria:
Inclusion Criteria:
* Age
* Between 6 and 12 months to participate in the vaccination arm of cohort 1 (cohort 1A)
* Between 3 and 12 months to participate in the natural infection arm of cohort 1 (cohort 1B)
* Between 13 and 35 months of age to participate in either the vaccination or natural infection arm of cohort 2
* Between 36 months and 5 years of age to participate in either the vaccination or natural infection arm of cohort 3
* Between 6 years and 8 years of age to participate in either the vaccination or natural infection arm of cohort 4
* Gestational age of ≥37 weeks at birth
* Parent/guardian can provide informed consent
* Available for the duration of the study
* History of previous IIV administration ONLY for participation in the vaccination arm of cohorts 2, 3, or 4
* Acute illness documented to be due to influenza virus ONLY for participation in the natural infection arms of cohorts 1-4
Exclusion Criteria:
* Immunosuppression as a result of an underlying illness or condition (including HIV or a primary immunodeficiency syndrome)
* Active neoplastic disease
* Use of potentially immunosuppressive medications currently or within the past year (including chemotherapeutic agents) or chronic (\>2 weeks) use of oral or inhaled steroid therapy
* A diagnosis of asthma requiring chronic controller medication
* Previous administration of influenza vaccine in the current influenza season ONLY for subjects receiving an influenza vaccination
* Receipt of immunoglobulin or another blood product within the year prior to study enrollment
* An acute illness within the previous 3 days or temperature \>38o on screening EXCEPT for participation in the natural infection arms of cohorts 1-4
* A contraindication to influenza vaccination EXCEPT infants between 3 and 5 months presenting with natural influenza infection whose only contraindication is their current age
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
8 Years
Study:
NCT02559505
Study Brief:
Protocol Section:
NCT02559505