Clinical evaluation of the lot-to-lot consistency of an enterovirus 71 vaccine in a commercial-scale phase IV clinical trial

References

• Huang CC, Liu CC, Chang YC, Chen CY, Wang ST, et al. Neurologic complications in children with enterovirus 71 infection[J]. N Engl J Med. 1999;341(13):936–7. PMID: 10 498488. doi:10.1056/NEJM199909233411302.
   PubMed Web of Science ®Google Scholar
• Chang PC, Chen SC, Chen KT. The current status of the disease caused by enterovirus 71 infections: epidemiology, pathogenesis, molecular epidemiology, and vaccine development. Int J Environ Res Public Health. 2016;13(9):890. PMID: 27618078.
   PubMed Web of Science ®Google Scholar
• Liu SL, Pan H, Liu P, Amer S, Chan T-C, Zhan J, Huo X, Liu Y, Teng Z, Wang L, et al. Comparative epidemiology and virology of fatal and nonfatal cases of hand, foot and mouth disease in mainland China fro-m 2008 to 2014. Rev Med Virol. 2015;25(2):115–28. PMID: 25704797.
   PubMed Web of Science ®Google Scholar
• WHO. Clinical considerations for evaluation of vaccines for prequalification. Points to consider for manufacturers of human vaccines; 2010 [accessed 2013 Set 12]. http://www.who.int/immunization/standards/vaccine/quality/clinicalconsiderations/oct10.pdf
   Google Scholar
• Chen YJ, Meng FY, Mao Q, Li J-X, Wang H, Liang Z-L, Zhang Y-T, Gao F, Chen Q-H, Hu Y, et al. Clinical evaluation for batch consistency of an inactivated enterovirus 71 vaccine in a large-scale phase 3 clinical trial. Hum Vaccin Immunot Her 2014;10(5):1366–72. PMID:24633366. doi:10.4161/hv.28397.
   PubMed Web of Science ®Google Scholar
• Mao QY, Wang Y, Bian L, Xu M, Liang Z. EV71 vaccine, a new tool to control outbreaks of hand, foot and mouth disease (HFMD). Expert Rev Vaccines. 2016;15(5):599–606. PMID: 26732723. doi:10.1586/14760584.2016.1138862.
   PubMed Web of Science ®Google Scholar
• Li Z-Q, Qin ZQ, Tan HF, Zhang C-H, Xu J-X, Chen J, Ni L-H, Yun X-X, Cui M, Huang Y, et al. Analysis of the coverage of inactivated enterovirus 71 (EV71) vaccine and adverse events following immunization with the EV71 vaccine among children from 2016 to 2019 in Guangzhou. Expert Rev Vaccines. 2021;20(7):907–18. PMID: 34036862. doi:10.1080/14760584.2021.1933451.
   PubMed Web of Science ®Google Scholar
• Li ML, Shih SR, Tolbert BS, Brewer G. Enterovirus A71 vaccines. Vaccines (Basel). 2021;9(3):199. PMID: 33673595. doi:10.3390/vaccines9030199.
   PubMed Web of Science ®Google Scholar
• Zhu FC, Meng FY, Li JX, Li X-L, Mao Q-Y, Tao H, Zhang Y-T, Yao X, Chu K, Chen Q-H, et al. Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2013;381(9882):2024–32. PMID: 23726161. doi:10.1016/S0140-6736(13)61049-1.
   PubMed Web of Science ®Google Scholar
• Nauta J. Vaccine equivalence and noninferiority immunogenicity trials. Statistics in clinical vaccine trials. Springer; 2011. doi:10.1007/978-3-642-14691-6_6.
   Google Scholar
• Guidelines on clinical evaluation of vaccines: regulatory expectations[J]. WHO Technical Report Series, 2004. Accept from: https://www.who.int/publications/m/item/WHO-TRS-1004-web-annex-9
   Google Scholar
• National Medical Products Administration. Guidelines for adverse event classification standards for clinical trials of preventive vaccines. [DC]. National Medical Products Administration, December 31; 2019. Available from: http://english.nmpa.gov.cn/2019-12/31/c_448385.htm
   Google Scholar
• Zhu F-C, Liang Z-L, Li XL, Ge H-M, Meng F-Y, Mao Q-Y, Zhang Y-T, Hu Y-M, Zhang Z-Y, Li J-X, et al. Immunogenicity and safety of an enterovirus 71 vaccine in healthy Chinese children and infants: a randomised, double-blind, placebo-controlled phase 2 clinical trial. Lancet. 2013;381(9871):1037–45. PMID: 23352749. doi:10.1016/S0140-6736(12)61764-4.
   PubMed Web of Science ®Google Scholar
• Meng FY, Li JX, Li XL, Chu K, Zhang Y-T, Ji H, Li L, Liang Z-L, Zhu F-C. Tolerability and immunogenicity of an inactivated enterovirus 71 vaccine in Chinese healthy adults and children: an open label, phase 1 clinical trial. Hum Vaccin Immunother. 2012;8(5):668–74. PMID: 22634437. doi:10.4161/hv.19521.
   PubMed Web of Science ®Google Scholar
• Zhu W, Jin P, Li JX, Zhu FC, Liu P. Correlates of protection for inactivated enterovirus 71 vaccine: the analysis of immunological surrogate endpoints. Expert Rev Vaccines. 2017;16(9):945–49. PMID: 28548626. doi:10.1080/14760584.2017.1335603.
   PubMed Web of Science ®Google Scholar
• Zhu F, Xu W, Xia J, Liang Z, Liu Y, Zhang X, Tan X, Wang L, Mao Q, Wu J, et al. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med. 2014;370(9):818–28. PMID: 24571754. doi:10.1056/NEJMoa1304923.
   PubMed Web of Science ®Google Scholar
• Li R, Liu L, Mo Z, Wang X, Xia J, Liang Z, Zhang Y, Li Y, Mao Q, Wang J, et al. An inactivated enterovirus 71 vaccine in healthy children. N Engl J Med. 2014;370(9):829–37. PMID: 24571755. doi:10.1056/NEJMoa1303224.
   PubMed Web of Science ®Google Scholar
• Gao J, Tang F, Wang Z, et al. Post-Marketing safety surveillance for inactivated enterovirus 71 vaccines in Jiangsu, China from 2017 to 2019. Vaccine. 2021;39(9):1415–19. PMID: 3354 1 795. doi:10.1016/j.vaccine.2021.01.048.
   PubMed Web of Science ®Google Scholar
• Bai YH, Li LI, Zhang JN, et al. Post-Marketing assessment on safety of inactived enterovirus type 71 vaccine by proactive monitoring[J]. Chin J Public Health. 2017;33(7):1045–1047. doi:10.11847/zgggws2017-33-07-03.
   Google Scholar
• Hu Y-M, et al. Immunogenicity, safety, and lot consistency of a novel inactivated enterovirus 71 vaccine in Chinese children aged 6 to 59 months. Clin Vaccine Immunol. 20(12):1805–11. PMID: 24108780. doi:10.1128/CVI.00491-13.
   PubMedGoogle Scholar
• Zhang Y, Liu L, Dong C, et al. Consistency of various batches of inactivated enterovirus 71 vaccine [J]. Chin J Biol. 2015;28(3):6.
   Google Scholar
• Xu Q, et al. Interchangeability of two enterovirus 71 inactivated vaccines in Chinese children: a phase IV, open-label, and randomized controlled trial. Vaccine. 2020;38(12):2671–77. PMID: 32067817. doi:10.1016/j.vaccine.2020.02.013.
   PubMed Web of Science ®Google Scholar
• Komatsu H, Shimizu Y, Takeuchi Y, Ishiko H, Takada H. Outbreak of severe neurologic involvement associated with enterovirus 71 infection. Pediatr Neurol. 1999;20(1):17–23. PMID: 10029254. doi:10.1016/s0887-8994(98)00087-3.
   PubMed Web of Science ®Google Scholar
• Lum LC, Wong KT, Lam SK, Chua KB, Goh AY. Neurogenic pulmonary oedema and enterovirus 71 encephalomyelitis. Lancet. 1998;352(9137):1391. PMID: 9802304. doi:10.1016/s0140-6736(05)60789-1.
   PubMed Web of Science ®Google Scholar
• Klein MH. EV71 vaccines: a first step towards multivalent hand, foot and mouth disease vaccines. Expert Rev Vaccines. 2015;14(3):337–40. PMID: 25536888.
   PubMed Web of Science ®Google Scholar