NCT01019837

Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics

Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Influenza H1N1

Interventions

Type	Name	Description
BIOLOGICAL	Focetria (Monovalent MF59-Adjuvanted vaccine)	Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

Timeline

• Start date: 2009-11-01
• Primary completion: 2009-11-01
• Completion: 2010-04-01
• First posted: 2009-11-25
• Last updated: 2009-11-25