drugset / Trial / NCT01022749
Efficacy Safety Study of Flu Vaccine in Immunodepression Patients
Phase 3
Completed
228 enrolled
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France · collabInstitut Pasteur · collabPierre and Marie Curie University · collabURC-CIC Paris Descartes Necker Cochin · collabUniversity of Paris 5 - Rene Descartes · collab
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2009-09
- Primary completion
- 2011-07
- Completion
- 2013-07
Publications
- Results Loison E, Poirier-Beaudouin B, Seffer V, Paoletti A, Abitbol V, Tartour E, Launay O, Gougeon ML. Suppression by thimerosal of ex-vivo CD4+ T cell response to influenza vaccine and induction of apoptosis in primary memory T cells. PLoS One. 2014 Apr 1;9(4):e92705. doi: 10.1371/journal.pone.0092705. eCollection 2014.
- Launay O, Abitbol V, Krivine A, Slama LB, Bourreille A, Dupas JL, Hebuterne X, Savoye G, Deplanque D, Bouhnik Y, Pelletier AL, Galtier F, Laharie D, Nachury M, Zerbib F, Allez M, Bommelaer G, Duclos B, Lucht F, Gougeon ML, Tartour E, Rozenberg F, Hanslik T, Beaugerie L, Carrat F; MICIVAX Study Group. Immunogenicity and Safety of Influenza Vaccine in Inflammatory Bowel Disease Patients Treated or not with Immunomodulators and/or Biologics: A Two-year Prospective Study. J Crohns Colitis. 2015 Dec;9(12):1096-107. doi: 10.1093/ecco-jcc/jjv152. Epub 2015 Sep 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MUTAGRIP | Vaccine | — | — |
| Comparator | Vaccine anti-H1N1 | Vaccine | — | — |
| Subject | Vaxigrip | Vaccine | — | — |