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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT00192218
Eligibility Criteria:
Inclusion Criteria:
* Healthy children enrolled in the target schools.
* Written informed consent obtained from the child's parent(s) if they agree to participate.
Exclusion Criteria:
* History of severe hypersensitivity (anaphylactic response) to egg products or previous FluMist
* FluMist is licensed exclusively for use in healthy individuals age 5-49 years. Therefore children for whom annual receipt of inactivated influenza vaccine for specific medical condition(s) is recommended will not be eligible. These conditions include:
* Asthma, other chronic pulmonary diseases, kidney disease, metabolic disease, heart disease, or hemoglobinopathy
* Immunosuppression of child
* Severe immunosuppression of a household member
* Pregnancy
* Past history of Guillian-Barre Syndrome
* Aspirin therapy within 1 month prior to FluMist or the anticipated use of aspirin containing products for one month after FluMist administration
* Administration of any inactivated vaccine within 2 weeks or any live vaccine within 4 weeks prior to receipt of FluMist
* Received anti-influenza medication in the past 48 hours
* Fever in the past 72 hours
* Moderate to severe nasal congestion (inability to breathe through the nose) or acute phase URI symptoms until the congestion has improved
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT00192218
Study Brief:
Protocol Section:
NCT00192218