Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains: A phase Ⅲ randomized clinical trial in adults

References

• Wilschut J, McElhaney JE, Palache AM. Influenza. Philadelphia, USA: Mosby Elsevier; 2006.
   Google Scholar
• Ducatez MF, Pelletier C, Meyer G, Influenza D. virus in cattle, France, 2011-2014. Emerg Infect Dis. 2015;21(2):368–371. doi:10.3201/eid2102.141449. PMID:25628038.
   PubMed Web of Science ®Google Scholar
• Mosnier A, Caini S, Daviaud I, Nauleau E, Bui TT, Debost E, Bedouret B, Agius G, van der Werf S, Lina B, et al. Clinical characteristics are similar across type A and B Influenza virus infections. PLoS One. 2015;10(9):e0136186. doi:10.1371/journal.pone.0136186. PMID:26325069.
   PubMed Web of Science ®Google Scholar
• Irving SA, Patel DC, Kieke BA, Donahue JG, Vandermause MF, Shay DK, Belongia EA. Comparison of clinical features and outcomes of medically attended influenza A and influenza B in a defined population over four seasons: 2004-2005 through 2007-2008. Influenza Other Respir Viruses. 2012;6(1):37–43. doi:10.1111/j.1750-2659.2011.00263.x. PMID:21668663.
   PubMed Web of Science ®Google Scholar
• Jennings L, Huang QS, Barr I, Lee PI, Kim WJ, Buchy P, Sanicas M, Mungall BA, Chen J. Literature review of the epidemiology of influenza B disease in 15 countries in the Asia-Pacific region. Influenza Other Respir Viruses. 2018;12(3):383–411. doi:10.1111/irv.12522. PMID:29127742.
   PubMed Web of Science ®Google Scholar
• Wu P, Presanis AM, Bond HS, Lau EHY, Fang VJ, Cowling BJ. A joint analysis of influenza-associated hospitalizations and mortality in Hong Kong, 1998-2013. Sci Rep. 2017;7(1):929. doi:10.1038/s41598-017-01021-x. PMID:28428558.
   PubMedGoogle Scholar
• Wu S, Wei Z, Greene CM, Yang P, Su J, Song Y, Iuliano AD, Wang Q. Mortality burden from seasonal influenza and 2009 H1N1 pandemic influenza in Beijing, China, 2007-2013. Influenza Other Respir Viruses. 2018;12(1):88–97. doi:10.1111/irv.12515. PMID:29054110.
   PubMed Web of Science ®Google Scholar
• 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(1):59–68. PMID:2309452.
   PubMed Web of Science ®Google Scholar
• van de Witte S, Nauta J, Montomoli E, Weckx JA. Phase III randomised trial of the immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in adult and elderly subjects, assessing both anti-haemagglutinin and virus neutralisation antibody responses. Vaccine. 2018;36:6030–6038. doi:10.1016/j.vaccine.2018.04.043. PMID:29709447.
   PubMed Web of Science ®Google Scholar
• Treanor JT, Albano FR, Sawlwin DC, Graves Jones A, Airey J, Formica N, Matassa V, Leong J. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study. Vaccine. 2017;35(15):1856–1864. doi:10.1016/j.vaccine.2017.02.066. PMID:28302411.
   PubMed Web of Science ®Google Scholar
• Pepin S, Donazzolo Y, Jambrecina A, Salamand C, Saville M. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults. Vaccine. 2013;31(47):5572–5578. doi:10.1016/j.vaccine.2013.08.069. PMID:24016810.
   PubMed Web of Science ®Google Scholar
• Tinoco JC, Pavia-Ruz N, Cruz-Valdez A, Aranza Doniz C, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged >/=18 years: a phase III, randomized trial. Vaccine. 2014;32(13):1480–1487. doi:10.1016/j.vaccine.2014.01.022. PMID:24486352.
   PubMed Web of Science ®Google Scholar
• Panatto D, Signori A, Lai PL, Gasparini R, Amicizia D. Heterogeneous estimates of influenza virus types A and B in the elderly: results of a meta-regression analysis. Influenza Other Respir Viruses. 2018;12(4):533–543. doi:10.1111/irv.12550. PMID:29498477.
   PubMed Web of Science ®Google Scholar
• Paul Glezen W, Schmier JK, Kuehn CM, Ryan KJ, Oxford J. The burden of influenza B: a structured literature review. Am J Public Health. 2013;103(3):e43–51. doi:10.2105/AJPH.2012.301137. PMID:23327249.
   PubMed Web of Science ®Google Scholar
• Lapinscki B, Pereira LA, Nogueira MB, Vidal LR, Riediger I, Debur MC, Presibella M, Raboni SM. Molecular epidemiology of influenza B virus and implications in immunization strategy, Southern Brazil. Vaccine. 2018;36(1):107–113. doi:10.1016/j.vaccine.2017.11.033. PMID:29174679.
   PubMed Web of Science ®Google Scholar
• Heikkinen T, Ikonen N, Ziegler T. Impact of influenza B lineage-level mismatch between trivalent seasonal influenza vaccines and circulating viruses, 1999-2012. Clin Infect Dis. 2014;59(11):1519–1524. doi:10.1093/cid/ciu664. PMID:25139969.
   PubMed Web of Science ®Google Scholar
• Belshe RB, Coelingh K, Ambrose CS, Woo JC, Wu X. Efficacy of live attenuated influenza vaccine in children against influenza B viruses by lineage and antigenic similarity. Vaccine. 2010;28(9):2149–2156. doi:10.1016/j.vaccine.2009.11.068. PMID:20003926.
   PubMed Web of Science ®Google Scholar
• Gatherer D. Passage in egg culture is a major cause of apparent positive selection in influenza B hemagglutinin. J Med Virol. 2010;82(1):123–127. doi:10.1002/jmv.21648. PMID:19950248.
   PubMed Web of Science ®Google Scholar
• Kishida N, Fujisaki S, Yokoyama M, Sato H, Saito R, Ikematsu H, Xu H, Takashita E, Tashiro M, Takao S, et al. Evaluation of influenza virus A/H3N2 and B vaccines on the basis of cross-reactivity of postvaccination human serum antibodies against influenza viruses A/H3N2 and B isolated in MDCK cells and embryonated hen eggs. Clin Vaccine Immunol. 2012;19(6):897–908. doi:10.1128/cvi.05726-11. PMID:22492743.
   PubMed Web of Science ®Google Scholar
• Kieninger D, Sheldon E, Lin WY, Yu CJ, Bayas JM, Gabor JJ, Esen M, Fernandez Roure JL, Narejos Perez S, Alvarez Sanchez C, et al. Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged >/=18 years. BMC Infect Dis. 2013;13:343. doi:10.1186/1471-2334-13-343. PMID:23883186.
   PubMed Web of Science ®Google Scholar
• de Boer PT, van Maanen BM, Damm O, Ultsch B, Dolk FCK, Crepey P, Pitman R, Wilschut JC, Postma MJ. A systematic review of the health economic consequences of quadrivalent influenza vaccination. Expert Rev Pharmacoecon Outcomes Res. 2017;17(3):249–265. doi:10.1080/14737167.2017.1343145. PMID:28613092.
   PubMed Web of Science ®Google Scholar
• Cox NJ, Ziegler T. Influenza viruses. In: Murray PR, Barron EJ, Jorgensen JH, Pfaller MA, Yolken RH, editors. Manual of clinical microbiology. 8th ed. Washington (DC): ASM Press; 2003. p. 1360–1365.
   Google Scholar
• U.S. Department of Health and Human Services FaDA, Center for Biologics Evaluation and Research. Guidance for industry: clinical data needed to support the licensure of trivalent inactivated influenza vaccines; 2007 [accessed 2010 Aug 17. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091985.pdf
   Google Scholar
• U.S. Department of Health and Human Services FaDA, Center for Biologics Evaluation and Research. Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials; [accessed 2010 Aug 17]. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRe
   Google Scholar