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Influenza

Immunogenicity and safety of the quadrivalent inactivated split-virion influenza vaccine in populations aged ≥ 3 years: A phase 3, randomized, double-blind, non-inferiority clinical trial

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Article: 2245721 | Received 29 Mar 2023, Accepted 03 Aug 2023, Published online: 16 Aug 2023

References

  • Fitzner J, Qasmieh S, Mounts AW, Alexander B, Besselaar T, Briand S, Brown C, Clark S, Dueger E, Gross D, et al. Revision of clinical case definitions: influenza-like illness and severe acute respiratory infection. Bull World Health Organ. 2018 Feb 1;96(2):122–20. doi:10.2471/BLT.17.194514. [Epub 27 Nov 2017]. PMID: 29403115.
  • Caini S, Kroneman M, Wiegers T, Guerche-Séblain C E, Paget J. Clinical characteristics and severity of influenza infections by virus type, subtype, and lineage: a systematic literature review. Influenza Other Respir Viruses. 2018 Nov;12(6):780–92. doi:10.1111/irv.12575. [Epub 20 Jul 2018]. PMID: 29858537.
  • 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 May;12(3):383–411. doi:10.1111/irv.12522. [Epub 7 Mar 2018]. PMID: 29127742.
  • French PMID. Vaccines against influenza WHO position paper – November 2012. Wkly Epidemiol Rec. 2012;87(47):461–76. English.
  • Li J, Chen Y, Wang X, Yu H. Influenza-associated disease burden in mainland China: a systematic review and meta-analysis. Sci Rep. 2021 Feb 3;11(1):2886. doi:10.1038/s41598-021-82161-z. PMID: 33536462.
  • Li S, Liu SS, Zhu AQ, Cui JZ, Qin Y, Zheng JD, Feng LZ, Wang LP, Li ZJ. The mortality burden of influenza in China: a systematic review. Zhonghua Yu Fang Yi Xue Za Zhi. 2019 Oct 6;53(10):1049–55. Chinese. doi:10.3760/cma.j.issn.0253-9624.2019.10.018. PMID: 31607054.
  • Ainslie KEC, Haber M, Orenstein WA. Challenges in estimating influenza vaccine effectiveness. Expert Rev Vaccines. 2019 Jun;18(6):615–28. doi:10.1080/14760584.2019.1622419. [Epub 31 May 2019]. PMID: 31116070.
  • Lewnard JA, Cobey S. Immune history and influenza vaccine effectiveness. Vaccines (Basel). 2018 May 21;6(2):28. doi:10.3390/vaccines6020028. PMID: 29883414.
  • Tenforde MW, Kondor RJG, Chung JR, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Monto AS, Martin ET, Belongia EA, et al. Effect of antigenic drift on influenza vaccine effectiveness in the United States—2019–2020. Clinical Infectious Diseases. 2021 Dec 6;73(11):e4244–50–e4250. doi:10.1093/cid/ciaa1884. PMID: 33367650.
  • Arefin MR, Masaki T, Kabir KMA, Tanimoto J. Interplay between cost and effectiveness in influenza vaccine uptake: a vaccination game approach. Proc Math Phys Eng Sci. 2019 Dec;475(2232):20190608. doi:10.1098/rspa.2019.0608. [Epub 18 Dec 2019]. PMID: 31892839.
  • Centers for Disease Control and Prevention. Past seasons vaccine effectiveness estimates. [accessed 2021 Dec 7]. https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates.html.
  • Gaglani M, Vasudevan A, Raiyani C, Murthy K, Chen W, Reis M, Belongia EA, McLean HQ, Jackson ML, Jackson LA, et al. Effectiveness of trivalent and quadrivalent inactivated vaccines against influenza B in the United States, 2011–2012 to 2016–2017. Clin Infect Dis. 2021 Apr 8;72(7):1147–57. doi:10.1093/cid/ciaa102. PMID: 32006430.
  • Pepin S, Dupuy M, Borja-Tabora CFC, Montellano M, Bravo L, Santos J, de Castro JA, Rivera-Medina DM, Cutland C, Ariza M, et al. Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6–35 months: a multi-season randomised placebo-controlled trial in the Northern and Southern hemispheres. Vaccine. 2019 Mar 22;37(13):1876–84. doi:10.1016/j.vaccine.2018.11.074. [Epub 14 Dec 2018]. PMID: 30558818.
  • NMPA. Technical guidelines for clinical studies of seasonal influenza virus vaccines. 2021. [accessed 2023 Jun 25]. https://www.cde.org.cn/main/news/viewInfoCommon/237d5f7de6bcfcd08037dcce873794f3.
  • Chu K, Xu K, Tang R, Tian X, Hu J, Yang T, Li C, Hu Y, Zeng G. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III study in healthy population aged ≥3 years. Vaccine. 2020 Aug 18;38(37):5940–6. doi:10.1016/j.vaccine.2020.06.071. [Epub 27 Jul 2020]. PMID: 32732142.
  • Huang X, Fan T, Li L, Nian X, Zhang J, Gao X, Zhao W, Chen W, Zhang Z, Yao Z, et al. Safety and immunogenicity of a quadrivalent, inactivated, split-virion influenza vaccine (IIV4-W) in healthy people aged 3–60 years: a phase III randomized clinical noninferiority trial. Human Vaccines & Immunotherapeutics. 2022 Jun 17;18(5):2079924. doi:10.1080/21645515.2022.2079924. [Epub ahead of print]. PMID: 35714276.
  • Tinoco JC, Pavia-Ruz N, Cruz-Valdez A, Aranza Doniz C, Chandrasekaran V, Dewé 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 Mar 14;32(13):1480–7. doi:10.1016/j.vaccine.2014.01.022. [Epub 28 Jan 2014]. PMID: 24486352.
  • Airey J, Albano FR, Sawlwin DC, Jones AG, Formica N, Matassa V, Leong J. Immunogenicity and safety of a quadrivalent inactivated influenza virus vaccine compared with a comparator quadrivalent inactivated influenza vaccine in a pediatric population: a phase 3, randomized noninferiority study. Vaccine. 2017 May 9;35(20):2745–52. doi:10.1016/j.vaccine.2017.03.028. [Epub 5 Apr 2017]. PMID: 28390934.
  • Pepin S, Szymanski H, Rochín Kobashi IA, Villagomez Martinez S, González 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 y of age: a phase III randomized controlled study. Hum Vaccin Immunother. 2016 Dec;12(12):3072–8. doi:10.1080/21645515.2016.1212143. [Epub 26 Aug 2016]. PMID: 27565435.
  • National Immunization Advisory Committee (NIAC) Technical Working Group (TWG), Influenza Vaccination TWG. Technical guidelines for seasonal influenza vaccination in China (2021–2022). Zhonghua Liu Xing Bing Xue Za Zhi. 2021 Oct 10;42(10):1722–49. Chinese. doi:10.3760/cma.j.cn112338-20210913-00732. PMID: 34814607.
  • 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 Apr 4;35(15):1856–64. doi:10.1016/j.vaccine.2017.02.066. [Epub 13 Mar 2017]. PMID: 28302411.
  • Kim TH, Choi JH, Park SH, Yoo JH, Lee DG, Choi SM, Kim YR, Lee MS, Choo EJ, Choi HJ. Safety and immunogenicity of a seasonal quadrivalent influenza vaccine (GC3110A) in healthy participants aged ≥ 65 years. Vaccine. 2021 Jun 16;39(27):3621–5. doi:10.1016/j.vaccine.2021.05.001. [Epub 13 May 2021]. PMID: 33992436.
  • Chang CY, Cho CY, Lai CC, Lu CY, Chang LY, Hung MC, Huang LM, Wu KG. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: a phase III, open label, single-arm study. Vaccine. 2020 May 8;38(22):3839–46. doi:10.1016/j.vaccine.2020.03.048. [Epub 10 Apr 2020]. PMID: 32284272.