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NCT02461758 · ClinicalTrials.gov registry record · Phase 4
Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT02461758 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 81 participants.
The verdict
NCT02461758, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent epidemiological investigation estimates that nearly 4 million people worldwide are affected and approximately 1.4 million of these cases occur in the United States. IBD can lead to debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can achieve clinical remission and decrease the risk of complications, but also increase the risk for opportunistic infections, including influenza. Multiple studies have shown lower influenza vaccine responses in patients with IBD compared to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza serum antibody concentration correlates with protection from infection following vaccination. Therefore, increasing influenza antibody responses in patients with IBD would appear to be critical to improving protection from influenza. A high dose (HD) influenza vaccine containing four times more hemagglutinin was licensed based on its ability to induce higher antibody concentrations compared to standard dose (SD) in adults 65 years or older.
Interventions
- BIOLOGICAL Standard dose Influenza vaccine (SDIV)
- BIOLOGICAL High dose influenza vaccine (HDIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2016-10 |
| Est. Completion | 2018-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02461758
The ClinicalTrials.gov registry entry for NCT02461758 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard dose Influenza vaccine (SDIV) is the first listed.
NCT02461758 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02461758 about?
NCT02461758 is a clinical study titled "Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients". Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent epidemiological investigation estimates that nearly 4 million people worldwide are affected and approximately 1.4 million of the...
What is the current status of trial NCT02461758?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2016-10. Estimated completion is 2018-07.
What interventions are being tested in trial NCT02461758?
The interventions under investigation include: Standard dose Influenza vaccine (SDIV) (BIOLOGICAL), High dose influenza vaccine (HDIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02461758?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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