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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT07192458
Eligibility Criteria:
Inclusion Criteria:
* Lung transplant recipient who enrolled and completed Visits 1, 2, and 3 of the DMID protocol number 22-0014 during the prior 2024-2025 or 2025-2026 influenza season, respectively
* Anticipated to be available for the duration of the study
* Can be reached by telephone, text message, email, or electronic health record messaging
Exclusion Criteria:
* Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant
* Recipient of a re-do lung transplant
* History of Guillain-Barre syndrome
* History of receiving the current season's influenza vaccine prior to study enrollment and/or Visit 1 of this follow-up study
* Pregnant person
* Laboratory-confirmed influenza disease after September 1st in the current influenza season and before enrollment in this follow-up study (patient can still receive the second influenza vaccination despite proven influenza disease after enrollment)
* CMVIG/IVIG/SCIG receipt within 28 days of each vaccine
* Receipt of rituximab or other B-cell depleting antibody (including proteasome inhibitors) therapy within 3 months of 1st vaccine dose (Day 0)
* Receipt of T-cell depleting therapies (anti-thymocyte globulin, alemtuzumab, daratumumab) between the completion of Visit 3 of the initial study and enrollment in this follow-up study
* Investigator concern about study participation
* Note: Criteria for temporarily delaying vaccine administration: The following conditions are temporary or self-limiting, and a participant may be included in the study once the condition has resolved, provided that the participant is otherwise eligible:
* Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute severe illness within 48 hours of enrollment
* Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks prior to potential study vaccination
No children have been enrolled in the DMID protocol number 22-0014; therefore, only adults will be enrolled in this current study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07192458
Study Brief:
Protocol Section:
NCT07192458