Immunological non-inferiority and safety of a quadrivalent inactivated influenza vaccine versus two trivalent inactivated influenza vaccines in China: Results from two studies

Xiaoqiang Liu, Juliana Park, Shengli Xia, Bin Liang, Shuangmin Yang, Yanxia Wang, Olga Syrkina, Nathalie Lavis, Shuzhen Liu, Chenyan Zhao, Jian Ding, Jieqiong Hu, Sandrine I Samson, Iris A de Bruijn, FSQ01 and FSQ02 Study Groups, Xiaoqiang Liu, Juliana Park, Shengli Xia, Bin Liang, Shuangmin Yang, Yanxia Wang, Olga Syrkina, Nathalie Lavis, Shuzhen Liu, Chenyan Zhao, Jian Ding, Jieqiong Hu, Sandrine I Samson, Iris A de Bruijn, FSQ01 and FSQ02 Study Groups

Abstract

Who universal trial numbers (utns): U1111-1174-4615 and U1111-1174-4698.

Clinicaltrials.gov: NCT04210349 and NCT03430089.

Keywords: China; elderly; immunogenicity; inactivated influenza vaccine; pediatric; quadrivalent; safety.

Conflict of interest statement

JP, OS, NL, JD, SIS, and IDB are employees of Sanofi and may hold shares and/or stock options in the company. BL and JH were employees of Sanofi at the time of these studies. XL and SY are employees of Yunnan Province Center for Disease Control and Prevention, Yunnan Province, SX and YW are employees of Henan Province Center for Disease Control and Prevention, Henan Province, SL and CZ are employees of National Institutes for Food and Drug Control, Beijing, all in China, and were contracted by Sanofi to conduct this research.

References

    1. Shu Y-L, Fang L-Q, de Vlas SJ, Gao Y, Richardus JH, Cao W-C.. Dual seasonal patterns for influenza, China. Emerg Infect Dis. 2010;16:1–12.
    1. Li J, Chen Y, Wang X, Yu H. Influenza-associated disease burden in mainland China: a systematic review and meta-analysis. Sci Rep. 2021;11:2886.
    1. Reed C, Meltzer MI, Finelli L, Fiore A. Public health impact of including two lineages of influenza B in a quadrivalent seasonal influenza vaccine. Vaccine. 2012;30:1993–98.
    1. Jain VK, Rivera L, Zaman K, Espos RA Jr., Sirivichayakul C, Quiambao BP, Rivera-Medina DM, Kerdpanich P, Ceyhan M, Dinleyici EC, et al. Vaccine for prevention of mild and moderate-to-severe influenza in children. N Engl J Med. 2013;369(26):2481–91. doi:10.1056/NEJMoa1215817.
    1. Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Hum Vaccin Immunother. 2012;8:81–88.
    1. Hendriks J, Hutubessy RCW, Grohmann G, Torelli G, Friede M, Kieny MP. Quadrivalent influenza vaccines in low and middle income countries: cost-effectiveness, affordability and availability. Vaccine. 2018;36:3993–97.
    1. Hu Y, Chu K, Lavis N, Li X, Liang B, Liu S, Shao M, Shu J-D, Tabar C, Samson S. Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China versus a comparator influenza vaccine: a phase IV randomized study. Hum Vaccin Immunother. 2019;15:1066–69. doi:10.1080/21645515.2019.1581541.
    1. Mo Z, Nong Y, Liu S, Shao M, Liao X, Go K, Lavis N. Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China. Hum Vaccin Immunother. 2017;13:1–7. doi:10.1080/21645515.2017.1285475.
    1. National Medical Products Administration (NMPA) . 年版《预防用疫苗临床试验不良反应分级标准指导原则》2005 Edition. 2005. [accessed 2022 Feb 3]. .
    1. Katz JM, Hancock K, Xu X. Serologic assays for influenza surveillance, diagnosis and vaccine evaluation. Expert Rev Anti Infect Ther. 2011;9:669–83.
    1. European Medicines Agency . Note for guidance on harmonization of requirements for influenza vaccines. 1997; [accessed 2022 Feb 16]. .
    1. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998;17:873–90.
    1. Greenberg DP, Robertson CA, Landolfi VA, Bhaumik A, Senders SD, Decker MD. Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age. Pediatr Infect Dis J. 2014;33:630–36.
    1. Pepin S, Szymanski H, Rochin Kobashi IA, Villagomez Martinez S, Gonzalez Zamora JF, Brzostek J, Huang L-M, Chiu C-H, Chen P-Y, 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;12:3072–78. doi:10.1080/21645515.2016.1212143.
    1. Pepin S, Donazzolo Y, Jambrecina A, Salamand C, Saville M. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults. Vaccine. 2013;31:5572–78.
    1. 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.
    1. Tao YY, Li JX, Hu YM, Hu YS, Zeng G, Zhu FC. Quadrivalent influenza vaccine (Sinovac Biotech) for seasonal influenza prophylaxis. Expert Rev Vaccines. 2021;20:1–11.
    1. Wang Y, Zhang Y, Wu H, Huang L, Yu H, Xie Z, Zhang H, Zhang W, Chen X, Zhang H, et al. Safety and immunogenicity of a quadrivalent inactivated subunit non-adjuvanted influenza vaccine: a randomized, double-blind, active-controlled phase 1 clinical trial. Vaccine. 2021;39:3871–78. doi:10.1016/j.vaccine.2021.05.070.
    1. Fu C, Greene CM, He Q, Liao Y, Wan Y, Shen J, Rong C, Zhou S. Dose effect of influenza vaccine on protection against laboratory-confirmed influenza illness among children aged 6 months to 8 years of age in southern China, 2013/14–2015/16 seasons: a matched case–control study. Hum Vaccin Immunother. 2020;16:595–601. doi:10.1080/21645515.2019.1662267.
    1. Hu Y, Shao M, Hu Y, Liang Q, Jia N, Chu K, Xu L, Li J, Li C, Zhu F. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III clinical trial in children aged 6–35 months in China. Hum Vaccin Immunother. 2020;16:1691–98. doi:10.1080/21645515.2020.1721994.
    1. Pepin S, Dupuy M, Borja-Tabora CFC, Montellano M, Bravo L, Santos J, de Castro J-A, 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;37:1876–84. doi:10.1016/j.vaccine.2018.11.074.
    1. Feng L, Yang P, Zhang T, Yang J, Fu C, Qin Y, Zhang Y, Ma C, Liu Z, Wang Q, et al. Technical guidelines for the application of seasonal influenza vaccine in China (2014–2015). Hum Vaccin Immunother. 2015;11:2077–101. doi:10.1080/21645515.2015.1027470.
    1. World Health Organization Vaccines against influenza WHO position paper - November 2012. Wkly Epidemiol Rec. 2012;87:461–76.
    1. Grohskopf LA, Alyanak E, Ferdinands JM, Broder KR, Blanton LH, Talbot HK, Fry AM. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on immunization practices, United States, 2021–22 influenza season. MMWR Recomm Rep. 2021;70:1–28. doi:10.15585/mmwr.rr7005a1.
    1. Coudeville L, Bailleux F, Riche B, Megas F, Andre P, Ecochard R. Relationship between haemagglutination-inhibiting antibody titres and clinical protection against influenza: development and application of a bayesian random-effects model. BMC Med Res Methodol. 2010;10:18.
    1. Haaheim LR, Katz JM. Immune correlates of protection against influenza: challenges for licensure of seasonal and pandemic influenza vaccines, Miami, FL, USA, March 1-3, 2010. Influenza Other Respir Viruses. 2011;5:288–95.
    1. Donken R, de Melker HE, Rots NY, Berbers G, Knol MJ. Comparing vaccines: a systematic review of the use of the non-inferiority margin in vaccine trials. Vaccine. 2015;33:1426–32.
    1. Wang Z, Ai X, Yang Z, Yang H. Considerations of technical evaluation and clinical trials for seasonal inactivated influenza vaccines. Chin J New Drugs. 2015;24:2660–63.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner