Inflammatory Bowel Disease (IBD) Clinical Trial
Official title:
Impact of Immunosuppression in Patients With Inflammatory Bowel Disease on Responsiveness to Influenza Vaccine
Verified date | December 2007 |
Source | Children's Hospital Boston |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The purpose of this study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) on immunosuppressive therapy with IBD patients on aminosalicylates and healthy historical controls.
Status | Completed |
Enrollment | 146 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years and older |
Eligibility |
Inclusion Criteria: 1. Crohn's disease, ulcerative colitis, or indeterminate colitis diagnosed by standard clinical, radiographic, endoscopic, and histologic criteria. 2. Age 5 years and older 3. Actively or previously followed by a gastroenterologist at Children's Hospital Boston 4. On non-immunosuppressants (aminosalicylates, antibiotics, or no medications) and/or immunosuppressants (steroids, immunomodulators, TNF-alpha inhibitors) for the past 30 days. Standard concomitant medications (e.g. antihistamines, acetaminophen) will be allowed. Exclusion Criteria: 1. History of bleeding disorder that would make hematoma likely (eg hemophilia, von Willebrand's disease) 2. Received influenza vaccination during the current influenza season 3. Contraindications to the influenza vaccine (such as severe allergic reaction to prior influenza vaccine) 4. Fever within 48 hr prior to injection 5. Receipt of another vaccination within 2 days of influenza vaccine dose (and no other vaccines planned for 2 days after influenza vaccine) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Boston | Thrasher Research Fund |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | seroprotection rate | 3-8 weeks after vaccination | No | |
Secondary | vaccine-associated adverse events | up to 8 weeks after vaccination | Yes | |
Secondary | antibody titer levels | 3-8 weeks after vaccination | No |
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