Influenza Disease Clinical Trial
Official title:
VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial.
The objective of this study is to demonstrate that influenza vaccination of nursing home workers is an effective intervention for reducing mortality of elderly people.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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