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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00138294
Eligibility Criteria:
Inclusion Criteria:
* signed informed consent form by adult participant or parent/ legal guardian who are able to understand and comply with the protocol and assent when appropriate (usually age greater than or equal to 7 years)
* healthy subject, 4 through 18 years of age and none of the exclusion criteria
Exclusion Criteria:
* history of hypersensitivity, especially anaphylactic reaction, to any components of FluMist™, including eggs or egg products
* on aspirin therapy or aspirin-containing therapy
* history of Guillain-Barré syndrome
* known or suspected immune deficiency diseases such as combined immunodeficiency, agammaglobulinemia, and thymic abnormalities and conditions such as human immunodeficiency virus infection, malignancy, leukemia or lymphoma
* on immunosuppressive therapies such as systemic corticosteroids, alkylating drugs, antimetabolites, or radiation
* close contact within 21 days after vaccination with immunocompromised individuals
* history of asthma or reactive airway disease
* history of chronic or underlying diseases for which the licensed inactivated flu vaccine (IIV-T) is recommended such as chronic disorders of the cardiovascular and pulmonary systems, or chronic conditions such as metabolic diseases, renal dysfunction or hemoglobinopathies that required medical follow-up or hospitalization during the preceding year
* concurrent use with an anti-influenza compound
* pregnant or plans to become pregnant within 42 days after vaccination
* nursing mother and
* any condition which, in the opinion of the investigator, interferes with evaluation of the vaccine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT00138294
Study Brief:
Protocol Section:
NCT00138294