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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT04093206
Eligibility Criteria:
Inclusion Criteria:
* Generally healthy male and female children
* 1-6 years of age
* Children attending kindergarten
* Signed informed consent by child's parent or legal guardian and willingness to participate in all study activities
Exclusion Criteria:
* Immune dysfunction and/or taking an immunosuppressive medication
* Child who has received flu vaccination
* Child who is still breastfed
* Child taking other food supplements
* Unable or unwilling to comply with study protocol, including ingesting investigational product, and completing subject dairy
* Current participation in another clinical study
* Severe co-morbidity or concomitant disease
* Concurrent disease or condition, which in the judgment of the investigator, would make the child inappropriate for participation in the study
* High risk of complications from influenza
* Allergies to yeast-derived products
* Severe environmental allergies requiring medication or need for allergy shots
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
6 Years
Study:
NCT04093206
Study Brief:
Protocol Section:
NCT04093206