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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT01764269
Eligibility Criteria:
Inclusion Criteria:
1. are 24 through 59 months of age,
2. have a visit at a study site anytime during the study period,
3. receive first dose LAIV or IIV in the season,
4. the parent has a cell phone with text messaging capabilities, and
5. the parent speaks English or Spanish.
Exclusion criteria:
1. any chronic medical condition in the child that precludes receipt of LAIV (except for history of asthma or a wheezing episode within the past 12 months noted in the medical record),
2. currently on oral or other systemic steroids or used in the past month,
3. currently on inhaled steroids or used in the past 2 weeks,
4. presence of fever \>=100.4 at time of vaccination,
5. administration of any antipyretic in the 6-hour period prior to vaccination,
6. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
7. parent only speaks a language other than English or Spanish,
8. parent's inability to read text messages,
9. child receiving the second dose of influenza vaccine in the current season.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Months
Maximum Age:
59 Months
Study:
NCT01764269
Study Brief:
Protocol Section:
NCT01764269