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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02461758
Eligibility Criteria:
CASES Specific Aim #1 Inclusion Criteria
* A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic and histopathologic criteria.
* Ages 18-64
* Currently taking anti-TNF therapy (infliximab, golilumab, adalimumab, or certolizumab) for at least 3 months
* Exclusion Criteria
* Received season's influenza vaccine
* Allergy to eggs or influenza vaccine
* Currently use of systemic steroids in the past 3 months
Specific Aim #2 Inclusion criteria
* A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic and histopathologic criteria.
* Ages 18-64
* Currently on vedolizumab therapy
Exclusion Criteria
* Received season's influenza vaccine
* Allergy to eggs or influenza vaccine
* Currently use of systemic steroids in the past 3 months
Control group Inclusion criteria
* Age 18-64
* Willing to participate in study
Control group Exclusion criteria
* Currently on immunosuppressive therapy
* Has a chronic health condition that may have an impact on vaccine antibody concentrations as deemed by the investigators, including chronic liver disease, celiac disease, history of solid organ or bone marrow transplantation.
* Older than age 65 years
* Unconfirmed Measles, Mumps, and Rubella (MMR) vaccination status
* Patients in whom venipuncture are not feasible due to poor tolerability or lack of easy access.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02461758
Study Brief:
Protocol Section:
NCT02461758