Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in healthy people aged 60 years or older: a randomized Phase III trial

References

• World Heath Organization (WHO). Influenza (Seasonal) Factsheet. 2018.
   Google Scholar
• Caini S, Huang QS, Ciblak MA, Kusznierz G, Owen R, Wangchuk S, Henriques CMP, Njouom R, Fasce RA, Yu H, et al. Epidemiological and virological characteristics of influenza B: results of the Global Influenza B Study. Influenza Other Respi Viruses. 2015;9(Suppl S1):3–12. doi:10.1111/irv.12319.
   PubMed Web of Science ®Google Scholar
• Macias AE, McElhaney JE, Chaves SS, Nealon J, Nunes MC, Samson SI, Seet BT, Weinke T, Yu H. The disease burden of influenza beyond respiratory illness. Vaccine. 2021;39(Suppl 1):A6–A14. doi:10.1016/j.vaccine.2020.09.048.
   PubMed Web of Science ®Google Scholar
• van Aalst R, Russo EM, Neupane N, Mahmud SM, Wilschut J, Samson SI, Chit A, Postma M, Young-Xu Y. Comparing the impact of high-dose versus standard dose influenza vaccines on hospitalization cost for cardiovascular and respiratory diseases: economic assessment in the US Veteran population during 5 respiratory seasons using an instrumental variable method. Vaccine. 2021;39(Suppl 1):A51–A5.
   PubMed Web of Science ®Google Scholar
• Lee VJ, Yap J, Ong JB, Chan KP, Lin RT, Chan SP, Goh KT, Leo Y-S, Chen MIC. Influenza excess mortality from 1950-2000 in tropical Singapore. PloS One. 2009;4:e8096. doi:10.1371/journal.pone.0008096.
   PubMed Web of Science ®Google Scholar
• Adlhoch C, Snacken R, Melidou A, Ionescu S, Penttinen P. The European Influenza Surveillance N. Dominant influenza A(H3N2) and B/Yamagata virus circulation in EU/EEA, 2016/17 and 2017/18 seasons, respectively. Euro Surveillance. 2018;23:18–00146.
   PubMedGoogle Scholar
• Simonsen L, Fukuda K, Schonberger LB, Cox NJ. The impact of influenza epidemics on hospitalizations. J Infect Dis. 2000;181(3):831–37. doi:10.1086/315320.
   PubMed Web of Science ®Google Scholar
• Greenberg DP, Robertson CA, Noss MJ, Blatter MM, Biedenbender R, Decker MD. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults. Vaccine. 2013;31(5):770–76. doi:10.1016/j.vaccine.2012.11.074.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA). Fluzone® high-dose quadrivalent prescribing information. 2020.
   Google Scholar
• Sanofi Pasteur. Fluzone® high-dose quadrivalent summary of product characteristics. 2020.
   Google Scholar
• Chang LJ, Meng Y, Janosczyk H, Landolfi V, Talbot HK. Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: a phase 3 randomized clinical trial. Vaccine. 2019;37:5825–34. doi:10.1016/j.vaccine.2019.08.016.
   PubMed Web of Science ®Google Scholar
• Sanchez L, Matsuoka O, Inoue S, Inoue T, Meng Y, Nakama T, Kato K, Pandey A, Chang L-J. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults ≥65 years of age: a randomized controlled clinical trial. Hum Vaccin Immunother. 2020;16:858–66. doi:10.1080/21645515.2019.1677437.
   PubMed Web of Science ®Google Scholar
• DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, Pollak R, Christoff J, Earl J, Landolfi V. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014;371(7):635–45. doi:10.1056/NEJMoa1315727.
   PubMed Web of Science ®Google Scholar
• Lee JKH, Lam GKL, Shin T, Samson SI, Greenberg DP, Chit A. Efficacy and effectiveness of high-dose influenza vaccine in older adults by circulating strain and antigenic match: an updated systematic review and meta-analysis. Vaccine. 2021;39(Suppl 1):A24–A35. doi:10.1016/j.vaccine.2020.09.004.
   PubMed Web of Science ®Google Scholar
• European Centre for Disease Prevention and Control (ECDC). Seasonal influenza vaccination in Europe. Vaccination recommendations and coverage rates in the EU Member States for eight influenza seasons: 2007–2008 to 2014–2015. 2017.
   Google Scholar
• DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Efficacy and immunogenicity of high-dose influenza vaccine in older adults by age, comorbidities, and frailty. Vaccine. 2015;33(36):4565–71. doi:10.1016/j.vaccine.2015.07.003.
   PubMed Web of Science ®Google Scholar
• Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17:857–72. doi:10.1002/(SICI)1097-0258(19980430)17:8<857::AID-SIM777>3.0.CO;2-E.
   PubMed Web of Science ®Google Scholar
• Mereckiene J, Cotter S, Nicoll A, Lopalco P, Noori T, Weber Jt, D'Ancona F, Levy-Bruhl D, Dematte L, Giambi C, et al. Seasonal influenza immunisation in Europe. Overview of recommendations and vaccination coverage for three seasons: pre-pandemic (2008/09), pandemic (2009/10) and post-pandemic (2010/11). Euro Surveillance. 2014;19:20780.
   PubMedGoogle Scholar
• Centers for Disease Control and Prevention (CDC). Seasonal Influenza (Flu): health professionals: advisory committee on immunization practices (ACIP) recommendations. 2019.
   Google Scholar
• Sanofi Pasteur. Trivalent Influenza Vaccine (Solit Virion, Inactivated) high dose summary of product characteristics. 2020.
   Google Scholar
• Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009;200(2):172–80. doi:10.1086/599790.
   PubMed Web of Science ®Google Scholar