Michaela K Nichols1, Melissa K Andrew1, Todd F Hatchette1, Ardith Ambrose1, Guy Boivin2, William Bowie3, Ayman Chit4, Gael Dos Santos5, May ElSherif1, Karen Green6, Francois Haguinet7, Scott A Halperin1, Barbara Ibarguchi8, Jennie Johnstone9, Kevin Katz10, Phillipe Lagacé-Wiens11, Joanne M Langley1, Jason LeBlanc1, Mark Loeb9, Donna MacKinnon-Cameron1, Anne McCarthy12, Janet E McElhaney13, Allison McGeer6, Andre Poirier14, Jeff Powis15, David Richardson16, Anne Schuind17, Makeda Semret18, Vivek Shinde19, Stephanie Smith20, Daniel Smyth21, Grant Stiver3, Geoffrey Taylor20, Sylvie Trottier2, Louis Valiquette22, Duncan Webster23, Lingyun Ye1, Shelly A McNeil24. 1. Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Nova Scotia, Canada. 2. Centre Hospitalier Universitaire de Québec, Québec, Québec, Canada. 3. University of British Columbia, Vancouver, British Columbia, Canada. 4. Sanofi Pasteur, Swiftwater, PA, USA; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada. 5. Business & Decision Life Sciences, Bruxelles, Belgium(2). 6. Mount Sinai Hospital, Toronto, Ontario, Canada. 7. GSK, Wavre, Belgium. 8. GSK, Mississauga, Ontario, Canada. 9. McMaster University, Hamilton, Ontario, Canada. 10. North York General Hospital, Toronto, Ontario, Canada. 11. St. Boniface Hospital, Winnipeg, Manitoba, Canada. 12. The Ottawa Hospital, Ottawa, Ontario, Canada. 13. Health Sciences North Research Institute, Sudbury, Ontario, Canada. 14. Centre Intégré Universitaire de santé et services sociaux, Quebec, Quebec, Canada. 15. Michael Garron Hospital, Toronto, Ontario, Canada. 16. William Osler Health System, Brampton, Ontario, Canada. 17. GSK, Rockville, MD, USA. 18. McGill University, Montreal, Québec, Canada. 19. GSK, King of Prussia, PA, USA. 20. University of Alberta Hospital, Edmonton, Alberta, Canada. 21. The Moncton Hospital, Moncton, New Brunswick, Canada. 22. Université de Sherbrooke, Sherbrooke, Québec, Canada. 23. Horizon Health, Saint John, New Brunswick, Canada. 24. Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: shelly.mcneil@nshealth.ca.
Abstract
BACKGROUND: Ongoing assessment of influenza vaccine effectiveness (VE) is critical to inform public health policy. This study aimed to determine the VE of trivalent influenza vaccine (TIV) for preventing influenza-related hospitalizations and other serious outcomes over three consecutive influenza seasons. METHODS: The Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN) conducted active surveillance for influenza in adults ≥16 years (y) of age during the 2011/2012, 2012/2013 and 2013/2014 seasons in hospitals across Canada. A test-negative design was employed: cases were polymerase chain reaction (PCR)-positive for influenza; controls were PCR-negative for influenza and were matched to cases by date, admission site, and age (≥65 y or <65 y). All cases and controls had demographic and clinical characteristics (including influenza immunization status) obtained from the medical record. VE was estimated as 1-OR (odds ratio) in vaccinated vs. unvaccinated patients × 100%. The primary outcome was VE of TIV for preventing laboratory-confirmed influenza-related hospitalization; secondary outcomes included VE of TIV for preventing influenza-related intensive care unit (ICU) admission/mechanical ventilation, and influenza-related death. RESULTS: Overall, 3394 cases and 4560 controls were enrolled; 2078 (61.2%) cases and 2939 (64.5%) controls were ≥65 y. Overall matched, adjusted VE was 41.7% (95% Confidence Interval (CI): 34.4-48.3%); corresponding VE in adults ≥65 y was 39.3% (95% CI: 29.4-47.8%) and 48.0% (95% CI: 37.5-56.7%) in adults <65 y, respectively. VE for preventing influenza-related ICU admission/mechanical ventilation in all ages was 54.1% (95% CI: 39.8-65.0%); in adults ≥65 y, VE for preventing influenza-related death was 74.5% (95% CI: 44.0-88.4%). CONCLUSIONS: While effectiveness of TIV to prevent serious outcomes varies year to year, we demonstrate a statistically significant and clinically important TIV VE for preventing hospitalization and other serious outcomes over three seasons. Public health messaging should highlight the overall benefit of influenza vaccines over time while acknowledging year to year variability. ClinicalTrials.gov Identifier: NCT01517191.
BACKGROUND: Ongoing assessment of influenza vaccine effectiveness (VE) is critical to inform public health policy. This study aimed to determine the VE of trivalent influenza vaccine (TIV) for preventing influenza-related hospitalizations and other serious outcomes over three consecutive influenza seasons. METHODS: The Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN) conducted active surveillance for influenza in adults ≥16 years (y) of age during the 2011/2012, 2012/2013 and 2013/2014 seasons in hospitals across Canada. A test-negative design was employed: cases were polymerase chain reaction (PCR)-positive for influenza; controls were PCR-negative for influenza and were matched to cases by date, admission site, and age (≥65 y or <65 y). All cases and controls had demographic and clinical characteristics (including influenza immunization status) obtained from the medical record. VE was estimated as 1-OR (odds ratio) in vaccinated vs. unvaccinated patients × 100%. The primary outcome was VE of TIV for preventing laboratory-confirmed influenza-related hospitalization; secondary outcomes included VE of TIV for preventing influenza-related intensive care unit (ICU) admission/mechanical ventilation, and influenza-related death. RESULTS: Overall, 3394 cases and 4560 controls were enrolled; 2078 (61.2%) cases and 2939 (64.5%) controls were ≥65 y. Overall matched, adjusted VE was 41.7% (95% Confidence Interval (CI): 34.4-48.3%); corresponding VE in adults ≥65 y was 39.3% (95% CI: 29.4-47.8%) and 48.0% (95% CI: 37.5-56.7%) in adults <65 y, respectively. VE for preventing influenza-related ICU admission/mechanical ventilation in all ages was 54.1% (95% CI: 39.8-65.0%); in adults ≥65 y, VE for preventing influenza-related death was 74.5% (95% CI: 44.0-88.4%). CONCLUSIONS: While effectiveness of TIV to prevent serious outcomes varies year to year, we demonstrate a statistically significant and clinically important TIV VE for preventing hospitalization and other serious outcomes over three seasons. Public health messaging should highlight the overall benefit of influenza vaccines over time while acknowledging year to year variability. ClinicalTrials.gov Identifier: NCT01517191.
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