Efficacy Safety Study of Flu Vaccine in Immunodepression Patients

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapy with patients not receiving immunosuppressants .

The main objective of the study is to evaluate the humoral immunogenicity of influenza vaccination in patients with IBD

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Institut Pasteur; Pierre and Marie Curie University; University of Paris 5 - Rene Descartes
• Treatments: Vaccines

Criteria

Inclusion criteria :

• informed consent signed

• Age between 18 to 64

• Patient suffering from chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis)

• For patients receiving at least one immunosuppressive or anti-TNF therapy: treatment introduced for at least 3 months

• Patient willing to participate in the study throughout its duration and acceptance procedures related to the study (blood samples, self questionnaires, nasal swab and telephone follow-up)

Exclusion criteria :

• Patient treated by corticosteroid alone without immunosuppressive or anti-TNF

• For women, being pregnant or positive pregnancy test

• Known allergy to any component of the study vaccine or a history of hypersensitivity reaction to influenza vaccination

• Fever (at least 37.5°C measured orally) or acute infection in the week prior to vaccination

• Received influenza vaccination in the 6 months preceding enrollment

• Known history of progressive neuropathy or Guillain-Barre

• Known infection with HIV and/or HBV (Ag-HBs positive) and/or HCV

• Other causes of severe immune deficiency

• Cellular therapy, immunoglobulin infusions, of blood products or monoclonal antibodies (except anti-TNF) in the 3 months prior to vaccination

• Patient deprived of freedom by an administrative or court order

• Patient non affiliated to a health social security system