Influenza Vaccination of Nursing Home Workers.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00359554|
Recruitment Status : Terminated
First Posted : August 2, 2006
Last Update Posted : February 7, 2007
|Condition or disease||Intervention/treatment||Phase|
|Influenza Disease||Biological: VAXIGRIPPE||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||4000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial.|
|Study Start Date :||September 2006|
|Study Completion Date :||October 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359554
|Hopital Saint Antoine Inserm U707|
|Paris, France, 75012|
|Principal Investigator:||Fabrice CARRAT, MD,||Assistance Publique - Hôpitaux de Paris|