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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT06054269
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years old;
* Have participated in the healthcare personnel cohort study at Hospital Nacional Cayetano Heredia or Hospital Nacional Arzobispo Loayza during 2016-2021;
* Work at the facility full-time (≥30 hours per week);
* Have routine, direct, hands-on or face-to-face contact with patients (≤1 meter) as part of a typical work shift, including, but not limited to, physicians, nurses, respiratory therapists, physical therapists, unit clerks, radiograph technicians, medical assistants, and transporters;
* Work at the facility for ≥1 year prior to enrollment and planning to continue working at the facility for one year after enrollment;
* Willing to receive influenza vaccination (adjuvanted or standard dose);
* Women of childbearing age must complete the following criteria to be eligible:
1. Have a negative urine pregnancy test performed by the study staff ≤24 hours preceding receipt of the vaccine;
2. Be willing to use a reliable form of contraception approved by the Investigator for ≤2 months after receiving the vaccine. If they are not currently using an approved contraceptive, study staff will provide access to contraceptives;
3. Must not be breastfeeding.
Exclusion Criteria:
* Have received a vaccine against influenza during the 2022 influenza season (season of clinical trial);
* Have a severe, life-threatening allergy to influenza vaccines, eggs, or influenza vaccine components;
* Have a history of Guillain-Barre Syndrome or other autoimmune diseases;
* Received blood or blood products within 3 months of enrollment;
* Be pregnant, confirmed by rapid pregnancy test.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06054269
Study Brief:
Protocol Section:
NCT06054269