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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT01525004
Eligibility Criteria:
Inclusion Criteria:
* Pediatric SOT patients (kidney, liver, heart, lungs, intestine, and/or multi-visceral)
* Must be at least 6 months after transplant.
* 3-17 years of age, inclusive.
* Available for duration of study.
* Parent or guardian able to be reached by phone.
Exclusion Criteria:
* History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein.
* History of Guillian-Barre syndrome.
* Receipt of rituximab within the past one year.
* Rejection treatment with intravenous steroid bolus within 30 days.
* Rejection treatment with monoclonal antibody or antilymphocyte preparation (e.g. Alemtuzumab, Muromonab-CD3, etc.) within 90 days.
* Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
* Have any condition that the investigator believes may interfere with successful completion of the study.
* History of received 2011-2012 influenza vaccine.
* Pregnant female.
* History of proven influenza disease after September 1, 2011.
* History of known infection with HIV, hepatitis B, or hepatitis C.
* History of known latex hypersensitivity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT01525004
Study Brief:
Protocol Section:
NCT01525004