Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination

Summary

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.

Timeline

Start

2009-11

Primary completion

2011-01

Completion

2012-12

Publications

• Results d'Alessandro E, Hubert D, Launay O, Bassinet L, Lortholary O, Jaffre Y, Sermet-Gaudelus I. Determinants of refusal of A/H1N1 pandemic vaccination in a high risk population: a qualitative approach. PLoS One. 2012;7(4):e34054. doi: 10.1371/journal.pone.0034054. Epub 2012 Apr 10.
• Results Launay O, Boelle PY, Krivine A, Grenet D, Boussaud V, Remus N, Corvol H, Chedevergne F, Hubert D, Sermet-Gaudelus I; Inserm MUCOFLU group. Factors associated with humoral immune response to pandemic A/H1N1(v) 2009 influenza vaccine in cystic fibrosis. Vaccine. 2014 Jul 31;32(35):4515-4521. doi: 10.1016/j.vaccine.2014.06.010. Epub 2014 Jun 17.
• Bucher J, Boelle PY, Hubert D, Lebourgeois M, Stremler N, Durieu I, Bremont F, Deneuville E, Delaisi B, Corvol H, Bassinet L, Grenet D, Remus N, Vodoff MV, Boussaud V, Troussier F, Leruez-Ville M, Treluyer JM, Launay O, Sermet-Gaudelus I. Lessons from a French collaborative case-control study in cystic fibrosis patients during the 2009 A/H1N1 influenza pandemy. BMC Infect Dis. 2016 Feb 1;16:55. doi: 10.1186/s12879-016-1352-2.

Drugs

Indications