Last reviewed · How we verify
Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1) (MUCOFLU)
Multicenter prospective cohort of approximately 1000 cystic fibrosis patients followed in the Ile de France during the 2009-2010 influenza season with the main objective to assess the effectiveness of antiviral vaccination (H1N1). All subjects will be included, without excluding factor. In particular populations at risk are additional infants 6 to 23 months, pregnant women and lung transplant will also be included. These people will be vaccinated with un-adjuvanted vaccine. If flu symptoms until the results of PCR to confirm or refute the diagnosis of influenza, oseltamivir is administered in accordance with official recommendations and based on the results of the pharmacokinetic study.
Details
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 439 |
| Start date | 2009-11 |
| Completion | 2012-12 |
Conditions
- Cystic Fibrosis With Gastrointestinal Manifestation
Interventions
- influenza vaccination
Primary outcomes
- immunogenicity of a A(H1N1)v influenza vaccine, administered in patients with cystic fibrosis — Day 21 for patients vaccinated with one dose of vaccine or Day 42 for patients vaccinated with 2 doses
Immunogénicity was evaluated as: Seroprotection rate (defined by the percentage of patients with serum anti-haemagglutinin antibody titre ≥ 1/40e), seroconversion rate (defined by the percentage of patients with antibody titre \<1/10e before vaccination and ≥ 1/40e after vaccination or with a titre ≥ 1/10e before vaccination and a titre at least 4-fold greater after vaccination) and seroconversion factor (defined by the ratio of the post/pre vaccination geometric mean titres) tested 3 weeks after the last influenza vaccination
Countries
France