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Human Vaccines & Immunotherapeutics Volume 15, 2019 - Issue 5
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Short Report

Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China versus a comparator influenza vaccine: a phase IV randomized study

Yuemei HuVaccine Clinical Evaluation Department, Jiangsu Center for Disease Prevention and Control, Nanjing, ChinaView further author information
,
Kai ChuVaccine Clinical Evaluation Department, Jiangsu Center for Disease Prevention and Control, Nanjing, ChinaView further author information
,
Nathalie LavisMedical Operations, Sanofi Pasteur, Lyon, FranceCorrespondence[email protected]
View further author information
,
Xiaoling LiMedical Operations, Sanofi Pasteur, Beijing, ChinaView further author information
,
Bill LiangMedical Department, Sanofi Pasteur, Beijing, ChinaView further author information
,
Shuzhen LiuDivision of Respiratory Virus Vaccines, National Institutes for Food and Drug Control, Beijing, ChinaView further author information
,
Ming ShaoDivision of Respiratory Virus Vaccines, National Institutes for Food and Drug Control, Beijing, ChinaView further author information
,
Jean-Denis ShuMedical Department, Sanofi Pasteur, Lyon, FranceView further author information
,
Cynthia TabarClinical Operations, Sanofi Pasteur, Lyon, FranceView further author information
&
Sandrine SamsonGlobal Medical, Sanofi Pasteur, Swiftwater, PA, USAView further author information
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Pages 1066-1069 | Received 20 Nov 2018, Accepted 01 Feb 2019, Published online: 02 Apr 2019

References

  • World Health Organization. Influenza (seasonal). 2018 Jan 31. [accessed 2018 Aug 17]. http://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal).
  • Feng L, Shay DK, Jiang Y, Zhou H, Chen X, Zheng Y, Jiang L, Zhang Q, Lin H, Wang S, et al. Influenza-associated mortality in temperate and subtropical Chinese cities, 2003–2008. Bull World Health Organ. 2012;90(4):279–88B. doi:10.2471/blt.11.096958.
  • Yu H, Feng L, Viboud CG, Shay DK, Jiang Y, Zhou H, Zhou M, Xu Z, Hu N, Yang W, et al. Regional variation in mortality impact of the 2009 A(H1N1) influenza pandemic in China. Influenza Other Respir Viruses. 2013;7(6):1350–60. doi:10.1111/irv.12121.
  • Yu H, Huang J, Huai Y, Guan X, Klena J, Liu S, Peng Y, Yang H, Luo J, Zheng J, et al. The substantial hospitalization burden of influenza in central China: surveillance for severe, acute respiratory infection, and influenza viruses, 2010–2012. Influenza Other Respir Viruses. 2014;8(1):53–65. doi:10.1111/irv.12205.
  • Fiore AE, Uyeki TM, Broder K, Finelli L, Euler GL, Singleton JA, Iskander JK, Wortley PM, Shay DK, Bresee JS, et al. Prevention and control of influenza with vaccines: recommendations of the advisory committee on immunization practices (ACIP), 2010. MMWR Recomm Rep. 2010;59:1–62.
  • World Health Organization. Vaccines against influenza WHO position paper - November 2012. Wkly Epidemiol Rec. 2012;87(47):461–76.
  • 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(8):2077–101. doi:10.1080/21645515.2015.1027470.
  • Zhou L, Su Q, Xu Z, Feng A, Jin H, Wang S, Feng Z. Seasonal influenza vaccination coverage rate of target groups in selected cities and provinces in China by season (2009/10 to 2011/12). PLoS One. 2013;8(9):e73724. doi:10.1371/journal.pone.0073724.
  • Zhang Y, Muscatello DJ, Wang Q, Yang P, Wu J, MacIntyre CR. Overview of influenza vaccination policy in Beijing, China: current status and future prospects. J Public Health Policy. 2017;38(3):366–79. doi:10.1057/s41271-017-0079-7.
  • 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(6):1–7. doi:10.1080/21645515.2017.1285475.
  • 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):5572–78. doi:10.1016/j.vaccine.2013.08.069.
  • Committee for Proprietary Medicinal Products (CPMP). Note for guidance on harmonisation of requirements for influenza vaccines. CPMP/BWP/214/96. 1996.
  • European Medicine Agency Committee for Medicinal Products for Human Use (CHMP). Guideline on the choice of the non-inferiority margin. 2005 July 27 [accessed 2019 Jan 3]. https://www.ema.europa.eu/documents/scientific-guideline/guideline-choice-non-inferiority-margin_en.pdf.
  • Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17:857–72.
  • International Conference on Harmonisation. Clinical safety data management: definitions and standards for expedited reporting E2A, Geneva, Switzerland. 1994.
  • Grohskopf LA, Shay DK, Shimabukuro TT, Sokolow LZ, Keitel WA, Bresee JS, Cox NJ. Prevention and control of seasonal influenza with vaccines. Recommendations of the advisory committee on immunization practices–United States, 2013–2014. MMWR Recomm Rep. 2013;62:1–43.
  • Zhu FC, Zhou W, Pan H, Lu L, Gerez L, Nauta J, Giezeman K, de Bruijn I. Safety and immunogenicity of two subunit influenza vaccines in healthy children, adults and the elderly: a randomized controlled trial in China. Vaccine. 2008;26(35):4579–84. doi:10.1016/j.vaccine.2008.05.082.
  • Haber P, Moro PL, Lewis P, Woo EJ, Jankosky C, Cano M. Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, vaccine adverse event reporting system (VAERS), July 1, 2013-May 31, 2015. Vaccine. 2016;34(22):2507–12. doi:10.1016/j.vaccine.2016.03.048.
  • Giezeman KM, Nauta J, de Bruijn IA, Palache AM. Trivalent inactivated subunit influenza vaccine influvac: 25-year experience of safety and immunogenicity. Vaccine. 2009;27(18):2414–17. doi:10.1016/j.vaccine.2009.02.008.

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