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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT00455169
Eligibility Criteria:
Inclusion criteria. Subjects must meet all relevant criteria to participate.
1. (a) Former premature (\< 30 weeks' gestation at birth), ELBW (\<1001 grams' birth weight) infant, 6 months, 0 days - 17 months, 31 days of age., OR (b) Former full term (37-42 weeks' gestation at birth), normal birth weight (\>2500 grams' birth weight) infant, 6 months, 0 days - 17 months, 31 days of age.
2. No prior influenza immunization.
3. Eligible for influenza immunization.
4. Parental permission.
5. Agreement of primary care provider.
6. Parents likely to be able to comply with study visits.
Exclusion criteria. Subjects may not participate if they meet any one of these criteria.
1. Known immunodeficiency.
2. Systemic corticosteroid administration at time of study enrollment.
3. Requiring supplemental oxygen.
4. Contraindication to influenza immunization (e.g. egg allergy).
5. Physician-diagnosed influenza illness in the current influenza season.
6. Any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Months
Study:
NCT00455169
Study Brief:
Protocol Section:
NCT00455169