Influenza Vaccination of Nursing Home Workers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial.|
- all-cause mortality of residents at one year
- hospitalizations of residents,morbidity of nursing home workers.
- A cost-effectiveness ratio of influenza vaccination will be calculated
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||October 2007|
Nursing homes will be randomized within each pair in two arms “incentive to vaccinate”, and “do-nothing”. In the arm “incentive to vaccinate”, vaccination campaigns will be carried out with face-to-face interviews of nursing home workers in order to achieve more than 80% of vaccination coverage. In the “do-nothing”, nursing home workers will be vaccinated as usual.
The main endpoint criterion is all-cause mortality of residents. Population sets will be all residents who will be present at start of the influenza season (-2 weeks) or who will be admitted during the influenza season (+ 2 weeks). Onset and end of influenza season will be given by regional influenza surveillance system. Secondary criteria are hospitalizations of residents, morbidity of nursing home workers. A cost-effectiveness ratio of influenza vaccination will be calculated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359554
|Hopital Saint Antoine Inserm U707|
|Paris, France, 75012|
|Principal Investigator:||Fabrice CARRAT, MD,||Assistance Publique - Hôpitaux de Paris|