Cluster-randomized Trial of Adjuvanted Versus Nonadjuvanted Trivalent Influenza Vaccine in 823 US Nursing Homes
Autor: | David H Canaday, H. Edward Davidson, Stefan Gravenstein, Kevin W. McConeghy, Elie Saade, Vince Mor, Lisa Han |
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Rok vydání: | 2020 |
Předmět: |
Microbiology (medical)
Trivalent influenza vaccine Squalene medicine.medical_specialty 030231 tropical medicine Polysorbates Influenza season Hospitalization rate 03 medical and health sciences 0302 clinical medicine Adjuvants Immunologic Internal medicine Cox proportional hazards regression Influenza Human Medicine Humans 030212 general & internal medicine Cluster randomised controlled trial Aged business.industry Influenza A Virus H3N2 Subtype medicine.disease Nursing Homes Pneumonia Infectious Diseases Influenza Vaccines Observational study business Nursing homes |
Zdroj: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 73(11) |
ISSN: | 1537-6591 |
Popis: | Background Influenza leads in preventable infection-related hospitalization in nursing home (NH) residents. The adjuvanted trivalent influenza vaccine (aTIV) is more immunogenic than similarly dosed nonadjuvanted trivalent influenza vaccine (TIV), and observational studies suggest aTIV better prevents hospitalizations in older adults. We prospectively tested this in an NH setting. Methods NHs with ≥50 long-stay residents aged ≥65 years were randomized to offer aTIV or TIV for residents for the 2016–2017 influenza season. Using intent-to-treat resident-level analysis with Cox proportional hazards regression models adjusted for clustering by facility and a priori baseline covariates (eg, age, heart failure, and facility-level characteristics), we assessed relative aTIV:TIV effectiveness for hospitalization (ie, all-cause, respiratory, and pneumonia and influenza [P&I]). Results We randomized 823 NHs, housing 50 012 eligible residents, to aTIV or TIV. Residents were similar between groups by age (mean, ~79 years), heart failure, lung disease, and influenza and pneumococcal vaccine uptake, except aTIV homes housed fewer Black residents (14.5 vs 18.9%). Staff vaccine uptake was similar (~55%). P&I and all-cause resident hospitalization rates were lower (adjusted HR [aHR], .80 [95% CI, .66–.98; P = .03] and .94 [.89–.99; P = .02], respectively) for aTIV versus TIV, while the respiratory hospitalization rate was similar, in a season where vaccine effectiveness was considered poor. Conclusions aTIV was more effective than TIV in preventing all-cause and P&I hospitalization from NHs during an A/H3N2-predominant season when TIV was relatively ineffective. Clinical Trials Registration NCT02882100. |
Databáze: | OpenAIRE |
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