3,280
Views
11
CrossRef citations to date
0
Altmetric
Research Paper

Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults ≥65 years of age: a randomized controlled clinical trial

ORCID Icon, , , , , ORCID Icon, , ORCID Icon & show all
Pages 858-866 | Received 03 Jul 2019, Accepted 29 Sep 2019, Published online: 19 Nov 2019

References

  • US CDC. 2018-19 acip background; 23 Aug 2018. [accessed 2019 Jan 30]. https://www.cdc.gov/flu/professionals/acip/2018-2019/background/background-epidemiology.htm.
  • Seidman JC, Richard SA, Viboud C, Miller MA. Quantitative review of antibody response to inactivated seasonal influenza vaccines. Influenza Other Respir Viruses. 2012;6:52–62. doi:10.1111/j.1750-2659.2011.00268.x. PMID: 21668661.
  • Smetana J, Chlibek R, Shaw J, Splino M, Prymula R. Influenza vaccination in the elderly. Hum Vaccin Immunother. 2018;14:540–49. doi:10.1080/21645515.2017.1343226. PMID: 28708957.
  • World Health Organization. Influenza. Vaccine use. Geneva (Switzerland): WHO; 2019. [accessed 2019 Mar 11]. https://www.who.int/influenza/vaccines/use/en/.
  • International Longevity Center Japan. A profile of older japanese. Tokyo, Japan: ILC-Japan; 2013 Mar31. [[accessed 2019 Mar 6]. http://www.ilcjapan.org/agingE/POJ13.html.
  • Lee JS, Kawakubo K. Influenza vaccination coverage in japan. Lancet. 2003;362:1767. doi:10.1016/S0140-6736(03)14870-2. PMID: 14643141.
  • Ministry of Health Labour and Welfare. Q&a on influenza, fy 2017. Tokyo, Japan: Ministry of Health, Labour and Welfare; 2017. [accessed 2019 Apr 2]. https://www.mhlw.go.jp/bunya/kenkou/kekkaku-kansenshou01/qa_eng.html.
  • Sugaya N, Shinjoh M, Nakata Y, Tsunematsu K, Yamaguchi Y, Komiyama O, Takahashi H, Mitamura K, Narabayashi A, Takahashi T, et al. Three-season effectiveness of inactivated influenza vaccine in preventing influenza illness and hospitalization in children in japan, 2013-2016. Vaccine. 2018;36:1063–71. doi:10.1016/j.vaccine.2018.01.024. PMID: 29361343.
  • Tisa V, Barberis I, Faccio V, Paganino C, Trucchi C, Martini M, Ansaldi F. Quadrivalent influenza vaccine: A new opportunity to reduce the influenza burden. J Prev Med Hyg. 2016;57:E28–33. PMID: 27346937.
  • Caini S, Huang QS, Ciblak MA, Kusznierz G, Owen R, Wangchuk S, Henriques CM, Njouom R, Fasce RA, Yu H, et al. Epidemiological and virological characteristics of influenza b: results of the global influenza b study. Influenza Other Respir Viruses. 2015;9(Suppl 1):3–12. doi:10.1111/irv.12319. PMID: 26256290.
  • Tsuzuki S, Schwehm M, Eichner M. Simulation studies to assess the long-term effects of japan’s change from trivalent to quadrivalent influenza vaccination. Vaccine. 2018;36:624–30. doi:10.1016/j.vaccine.2017.12.058. PMID: 29292176.
  • Robertson CA, DiazGranados CA, Decker MD, Chit A, Mercer M, Greenberg DP. Fluzone(r) high-dose influenza vaccine. Expert Rev Vaccines. 2016;15:1495–505. doi:10.1080/14760584.2016.1254044. PMID: 27813430.
  • DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, Pollak R, Christoff J, Earl J, Landolfi V, et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014;371:635–45. doi:10.1056/NEJMoa1315727. PMID: 25119609.
  • 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;200:172–80. doi:10.1086/599790. PMID: 19508159.
  • Izurieta HS, Chillarige Y, Kelman J, Wei Y, Lu Y, Xu W, Lu M, Pratt D, Chu S, Wernecke M, et al. Relative effectiveness of cell-cultured and egg-based influenza vaccines among the u.S. Elderly, 2017–18. J Infect Dis. 2018. doi:10.1093/infdis/jiy716. PMID: 30561688.
  • Young-Xu Y, Snider JT, van Aalst R, Mahmud SM, Thommes EW, Lee JKH, Greenberg DP, Chit A. Analysis of relative effectiveness of high-dose versus standard-dose influenza vaccines using an instrumental variable method. Vaccine. 2019;37:1484–90. doi:10.1016/j.vaccine.2019.01.063. PMID: 30745146.
  • DiazGranados CA, Robertson CA, Talbot HK, Landolfi V, Dunning AJ, Greenberg DP. Prevention of serious events in adults 65 years of age or older: A comparison between high-dose and standard-dose inactivated influenza vaccines. Vaccine. 2015;33:4988–93. doi:10.1016/j.vaccine.2015.07.006. PMID: 26212007.
  • Robison SG, Thomas AR. Assessing the effectiveness of high-dose influenza vaccine in preventing hospitalization among seniors, and observations on the limitations of effectiveness study design. Vaccine. 2018;36:6683–87. doi:10.1016/j.vaccine.2018.09.050. PMID: 30287157.
  • Shay DK, Chillarige Y, Kelman J, Forshee RA, Foppa IM, Wernecke M, Lu Y, Ferdinands JM, Iyengar A, Fry AM, et al. Comparative effectiveness of high-dose versus standard-dose influenza vaccines among us medicare beneficiaries in preventing postinfluenza deaths during 2012–2013 and 2013–2014. J Infect Dis. 2017;215:510–17. doi:10.1093/infdis/jiw641. PMID: 28329311.
  • Chang LJ, Meng Y, Janosczyk H, Landolfi V, Talbot HK. Safety and immunogenicity of high-dose quadrivalent influenza vaccine administered by intramuscular route in subjects aged 65 years and older (oral abstract). San Francisco (CA): IDWeek. 2018 October 6.
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Clinical safety data management: definitions and standards for expedited reporting e2a. Geneva (Switzerland): International Council for Harmonisation;1994 Oct. [accessed 2019 Jan 22]. https://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-safety-data-management-definitions-and-standards-for-expedited-reporting.html.
  • 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;31:770–76. doi:10.1016/j.vaccine.2012.11.074. PMID: 23228813.
  • Wilkinson K, Wei Y, Szwajcer A, Rabbani R, Zarychanski R, AM A-S, Mahmud SM. Efficacy and safety of high-dose influenza vaccine in elderly adults: A systematic review and meta-analysis. Vaccine. 2017;35:2775–80. doi:10.1016/j.vaccine.2017.03.092. PMID: 28431815.
  • Samson SI, Leventhal PS, Salamand C, Meng Y, Seet BT, Landolfi V, Greenberg D, Hollingsworth R. Immunogenicity of high-dose trivalent inactivated influenza vaccine: A systematic review and meta-analysis. Expert Rev Vaccines. 2019;18:295–308. doi:10.1080/14760584.2019.1575734. PMID: 30689467.
  • Ikeno D, Kimachi K, Kino Y, Harada S, Yoshida K, Tochihara S, Itamura S, Odagiri T, Tashiro M, Okada K, et al. Immunogenicity of an inactivated adjuvanted whole-virion influenza a (h5n1, nibrg-14) vaccine administered by intramuscular or subcutaneous injection. Microbiol Immunol. 2010;54:81–88. doi:10.1111/j.1348-0421.2009.00191.x. PMID: 20377741.
  • Cook IF, Barr I, Hartel G, Pond D, Hampson AW. Reactogenicity and immunogenicity of an inactivated influenza vaccine administered by intramuscular or subcutaneous injection in elderly adults. Vaccine. 2006;24:2395–402. doi:10.1016/j.vaccine.2005.11.057. PMID: 16406171.
  • Pitel M. The subcutaneous injection. Am J Nurs. 1971;71:76–79. PMID: 5203348.
  • Banchereau J, Briere F, Caux C, Davoust J, Lebecque S, YJ L, Pulendran B, Palucka K. Immunobiology of dendritic cells. Annu Rev Immunol. 2000;18:767–811. doi:10.1146/annurev.immunol.18.1.767. PMID: 10837075.
  • Organisation for Economic Co-operation and Development. Influenza vaccination rates (indicator). Paris (France): OECD; 2018. [accessed 2019 Feb 15]. https://data.oecd.org/healthcare/influenza-vaccination-rates.htm.
  • 56th World Health Assembly. Prevention and control of influenza pandemics and annual epidemics. Geneva (Switzerland): World Health Organization; 2003. https://apps.who.int/iris/bitstream/handle/10665/78320/ea56r19.pdf?sequence=1&isAllowed=y.
  • Lee JKH, Lam GKL, Shin T, Kim J, Krishnan A, Greenberg DP, Chit A. Efficacy and effectiveness of high-dose versus standard-dose influenza vaccination for older adults: A systematic review and meta-analysis. Expert Rev Vaccines. 2018;17:435–43. doi:10.1080/14760584.2018.1471989. PMID: 29715054.