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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01215734
Eligibility Criteria:
Inclusion Criteria:
* Allogeneic hematopoietic stem cell transplant recipients who are \>6 post-transplant
* greater than or equal to 18 years of age
* Available for duration of study
* If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD): only those on stable doses for at least 4 weeks or on tapering doses will be eligible.
Exclusion Criteria:
* History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein
* History of Guillain-Barre syndrome
* Evidence of hematologic malignancy or disease relapse post-transplant (mixed chimerisms and molecular evidence of disease is permitted)
* Non-allogeneic (e.g. autologous) hematopoietic SCT recipients
* History of receiving 2011 - 2012 influenza vaccine
* History of proven influenza disease after September 1, 2011.
* Pregnant females
* 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
* Platelet count less than 50,000 cells/μL
* History of known infection with HIV, Hepatitis B or Hepatitis C
* History of known latex hypersensitivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01215734
Study Brief:
Protocol Section:
NCT01215734