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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: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT02461758 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine. Higher antibody concentrations are associated with better protection from infection.
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 |
What the finished NCT02461758 record still lists
NCT02461758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard dose Influenza vaccine (SDIV) is the first listed.
NCT02461758 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02461758's enrollment target sits among peer trials
81 940th of 2000 higher than 1,055 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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