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Research Paper

Safety, immunogenicity, and lot-to-lot consistency of a split-virion quadrivalent influenza vaccine in younger and older adults: A phase III randomized, double-blind clinical trial

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Pages 596-608 | Received 16 Jun 2017, Accepted 19 Sep 2017, Published online: 27 Nov 2017

References

  • McCullers JA, Saito T, Iverson AR. Multiple genotypes of influenza B virus circulated between 1979 and 2003. J Virol. 2004;78:12817-28. doi:10.1128/JVI.78.23.12817-12828.2004. PMID:15542634
  • Rota PA, Wallis TR, Harmon MW, Rota JS, Kendal AP, Nerome K. Cocirculation of two distinct evolutionary lineages of influenza type B virus since 1983. Virology 1990;175:59-68. doi: not available. doi:10.1016/0042-6822(90)90186-U. PMID:2309452
  • Centers for Disease Control and Prevention. Past Weekly Surveillance Reports. Atlanta, Georgia: CDC;2016 [accessed 2016 Dec 28]. http://www.cdc.gov/flu/weekly/pastreports.htm.
  • National Advisory Committee on Immunization (NACI). Statement on seasonal influenza vaccine for 2014–2015. Ottawa, Canada: Public Health Agency of Canada;2014 [accessed 2016 Aug 29]. http://www.phac-aspc.gc.ca/naci-ccni/flu-grippe-eng.php.
  • Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Hum Vaccin Immunother. 2012;8:81-8. doi:10.4161/hv.8.1.17623. PMID:22252006
  • 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
  • Barr IG, Vijaykrishna D, Sullivan SG. Differential age susceptibility to influenza B/Victoria lineage viruses in the 2015 Australian influenza season. Euro Surveill. 2016;21. doi:10.2807/1560-7917.ES.2016.21.4.30118. PMID:26848118
  • Zhao B, Qin S, Teng Z, Chen J, Yu X, Gao Y, Shen J, Cui X, Zeng M, Zhang X. Epidemiological study of influenza B in Shanghai during the 2009–2014 seasons: implications for influenza vaccination strategy. Clin Microbiol Infect. 2015;21:694-700. doi:10.1016/j.cmi.2015.03.009. PMID:25882368
  • Harvala H, Smith D, Salvatierra K, Gunson R, von Wissmann B, Reynolds A, Frew C, MacLean A, Hunt A, Yirrell D, et al. Burden of influenza B virus infections in Scotland in 2012/13 and epidemiological investigations between 2000 and 2012. Euro Surveill. 2014;19:1-7. doi:10.2807/1560-7917.ES2014.19.37.20903.
  • Tran D, Vaudry W, Moore D, Bettinger JA, Halperin SA, Scheifele DW, Jadvji T, Lee L, Mersereau T. Hospitalization for Influenza A Versus B. Pediatrics. 2016;138. doi:10.1542/peds.2015-4643. PMID:27535144
  • Sharabi S, Drori Y, Micheli M, Friedman N, Orzitzer S, Bassal R, Glatman-Freedman A, Shohat T, Mendelson E, Hindiyeh M, et al. Epidemiological and Virological Characterization of Influenza B Virus Infections. PLoS One. 2016;11:e0161195. doi:10.1371/journal.pone.0161195. PMID:27533045
  • Pepin S, Donazzolo Y, Jambrecina A, Salamand C, Saville M. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults. Vaccine. 2013;31:5572-8. doi:10.1016/j.vaccine.2013.08.069. PMID:24016810
  • Cadorna-Carlos JB, Nolan T, Borja-Tabora CF, Santos J, Montalban MC, de Looze FJ, Eizenberg P, Hall S, Dupuy M, Hutagalung Y, et al. Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. Vaccine. 2015;33:2485-92. doi:10.1016/j.vaccine.2015.03.065. PMID:25843270
  • Pepin S, Szymanski H, Rochin Kobashi IA, Villagomez Martinez S, Gonzalez Zamora JF, Brzostek J, Huang LM, Chiu CH, Chen PY, Ahonen A, et al. Safety and immunogenicity of an intramuscular quadrivalent Influenza vaccine in children 3 to 8 years of age: a phase III randomised controlled study. Hum Vaccin Immunother. 2016;12:0. doi:10.1080/21645515.2016.1212143.
  • Moa AM, Chughtai AA, Muscatello DJ, Turner RM, MacIntyre CR. Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. Vaccine. 2016;34:4092-102. doi:10.1016/j.vaccine.2016.06.064. PMID:27381642
  • Petrie JG, Ohmit SE, Johnson E, Truscon R, Monto AS. Persistence of Antibodies to Influenza Hemagglutinin and Neuraminidase Following One or Two Years of Influenza Vaccination. J Infect Dis. 2015;212:1914-22. doi:10.1093/infdis/jiv313. PMID:26014800
  • Mutsaerts E, Madhi SA, Cutland CL, Jones S, Hugo A, Trenor S, Treurnicht FK, Klipstein-Grobusch K, Weinberg A, Nunes MC. Influenza vaccination of pregnant women protects them over two consecutive influenza seasons in a randomized controlled trial. Expert Rev Vaccines. 2016;15:1055-62. doi:10.1080/14760584.2016.1192473. PMID:27212228
  • Houdouin V, Lavis N, Meyzer C, Jeziorski E, Merlin E, Pinquier D, Deschenes G, Mothe E, Petit C, Plantaz D, et al. Safety of the Northern Hemisphere 2014/2015 formulation of the inactivated split-virion intramuscular trivalent influenza vaccine. Vaccine Reports. 2016;6:1-7. doi: not available. doi:10.1016/j.vacrep.2016.07.001. PMID:28580433
  • Gorse GJ, Falsey AR, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015;33:1151-9. doi:10.1016/j.vaccine.2015.01.025. PMID:25613721
  • Sullivan SJ, Jacobson R, Poland GA. Advances in the vaccination of the elderly against influenza: role of a high-dose vaccine. Expert Rev Vaccines. 2010;9:1127-33. doi:10.1586/erv.10.117. PMID:20923264
  • Haq K, McElhaney JE. Immunosenescence: Influenza vaccination and the elderly. Curr Opin Immunol. 2014;29:38-42. doi:10.1016/j.coi.2014.03.008. PMID:24769424
  • Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, Fukuda K. Influenza-associated hospitalizations in the United States. JAMA. 2004;292:1333-40. doi:10.1001/jama.292.11.1333. PMID:15367555
  • McElhaney JE. Influenza vaccine responses in older adults. Ageing Res Rev. 2011;10:379-88. doi:10.1016/j.arr.2010.10.008. PMID:21055484
  • European Centre for Disease Control and Prevention. Influenza vaccination. 2005-2015. doi:https://ecdc.europa.eu/en/seasonal-influenza/prevention-and-control/influenza-vaccination
  • United States Food and Drug Administration. Guidance for Industry. Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines. Rockville, MD: US FDA, 2007.
  • Petrie JG, Ohmit SE, Johnson E, Cross RT, Monto AS. Efficacy studies of influenza vaccines: effect of end points used and characteristics of vaccine failures. J Infect Dis. 2011;203:1309-15. doi:10.1093/infdis/jir015. PMID:21378375
  • Ohmit SE, Petrie JG, Cross RT, Johnson E, Monto AS. Influenza hemagglutination-inhibition antibody titer as a correlate of vaccine-induced protection. J Infect Dis. 2011;204:1879-85. doi:10.1093/infdis/jir661. PMID:21998477
  • Trombetta CM, Montomoli E. Influenza immunology evaluation and correlates of protection: a focus on vaccines. Expert Rev Vaccines. 2016;15:967-76. doi:10.1586/14760584.2016.1164046. PMID:26954563
  • Black S, Nicolay U, Vesikari T, Knuf M, Del Giudice G, Della Cioppa G, Tsai T, Clemens R, Rappuoli R. Hemagglutination inhibition antibody titers as a correlate of protection for inactivated influenza vaccines in children. Pediatr Infect Dis J. 2011;30:1081-5. doi:10.1097/INF.0b013e3182367662. PMID:21983214
  • Gravenstein S, Drinka P, Duthie EH, Miller BA, Brown CS, Hensley M, Circo R, Langer E, Ershler WB. Efficacy of an influenza hemagglutinin-diphtheria toxoid conjugate vaccine in elderly nursing home subjects during an influenza outbreak. J Am Geriatr Soc 1994;42:245-51. doi:10.1111/j.1532-5415.1994.tb01746.x. PMID:8120307
  • Committee for Medicinal Products for Human Use. Guideline on influenza vaccines. Non-clinical and clinical module London, UK: European Medicines Agency, 2016.
  • Dunning AJ, DiazGranados CA, Voloshen T, Hu B, Landolfi VA, Talbot HK. Correlates of Protection against Influenza in the Elderly: Results from an Influenza Vaccine Efficacy Trial. Clin Vaccine Immunol. 2016;23:228-35. doi:10.1128/CVI.00604-15. PMID:26762363
  • Trombetta CM, Perini D, Mather S, Temperton N, Montomoli E. Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future. Vaccines (Basel). 2014;2:707-34. doi:10.3390/vaccines2040707. PMID:26344888
  • US Centers for Disease Control and Prevention. People at high risk of developing flu-related complications. Atlanta, Georgia: CDC;25 Aug 2016 [accessed 28 Dec 2016]. http://www.cdc.gov/flu/about/disease/high_risk.htm.
  • World Health Organization. Serological diagnosis of influenza by microneutralization assay. 2010. http://www.who.int/influenza/gisrs_laboratory/2010_12_06_serologimicroneutralizationassay.2010.cal_diagnosis_of_influenza_by_microneutralization_assay.pdf