Influenza H1N1 Clinical Trial
Official title:
Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics
The spread of Influenza H1N1 has prompted the development of vaccines against this virus. IBD patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against influenza H1N1 in patients with IBD who treated with immunomodulatory drugs.
200 patients with IBD and 200 healthy subjects will participate in the study. All the
subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day of
vaccination and 4 weeks later.
The evaluation will include:
Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the
presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test.
Safety of the vaccine:
- Records of adverse event
- Assessment of disease activity : CDAI and MAYO score
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01178918 -
Non-specific Response to H1N1 Vaccine
|