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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT03277703
Eligibility Criteria:
Inclusion Criteria:
* Children ages 3-22 years
* Rheumatologic condition (JIA, Uveitis, SLE and other rheumatologic disorders) or inflammatory bowel disease (Crohn's disease or ulcerative colitis) and who are receiving immunosuppressive therapies as follows:
* TNF inhibitors \[etanercept (Enbrel), adalimumab (Humira®), infliximab (Remicade®)\]
* anti IL -1 \[anakinra (Kineret®) or canakinumab (Ilaris®)\]
* IL-6 tocilizumab (Actemra®)
* anti IL-12/23 ustekinumab (Stelara®)
* anti CTLA-4 \[abatacept (Orencia®)\]
* vedolizumab (Entyvio®)
* azathioprine (Imuran®)
* 6 mercaptopurine (Purinethol®)
* Cyclosporine
* Leflunomide
* Mycophenolate
* methotrexate (Otrexup® or Rasuvo®)
Exclusion Criteria:
* Prior allergic reaction to any vaccine components
* Other contraindication to influenza vaccination
* Severe egg allergy
* Pregnancy
* Prior Guillain-Barre syndrome
* Therapy with oral corticosteroids ≥2 mg/mg/day within 4 weeks of study entry
* Prior rituximab
* Prior cyclophosphamide
* Prior IVIG within 8 weeks
* Acute febrile illness at time of study evaluation
* No prior history of two doses of influenza in the past for ages 3-8 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
22 Years
Study:
NCT03277703
Study Brief:
Protocol Section:
NCT03277703