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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT01995851
Eligibility Criteria:
Children in schools randomized to LAIV cannot receive this vaccine if they have any of the following contraindications: severe asthma (defined as currently on oral or high-dose inhaled glucocorticosteriods or active wheezing) or medically attended wheezing in the 7 days prior to vaccination; receiving aspirin or aspirin-containing therapy because of the association of Reye's syndrome with aspirin and wild-type influenza infection; or immune-compromising conditions due to underlying disease and/or therapy, as the vaccine contains live attenuated virus. These children will receive TIV instead, unless they have a contraindication to receiving TIV. Children in schools assigned to TIV cannot receive this vaccine if they have any of the following contraindications: an anaphylactic reaction to a previous dose; an anaphylactic reaction to any of the vaccine components, with the exception of egg; or Guillain-Barré Syndrome (GBS) within six weeks of a previous influenza vaccination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
14 Years
Study:
NCT01995851
Study Brief:
Protocol Section:
NCT01995851