Immunogenicity and safety of an inactivated enterovirus 71 vaccine co-administered with measles-mumps-rubella vaccine and live-attenuated Japanese encephalitis vaccine: a phase 4, single-center, randomized controlled trial

References

• Ooi MH, Wong SC, Lewthwaite P, Cardosa MJ, Solomon T. Clinical features, diagnosis, and management of enterovirus 71. Lancet Neurol. 2010;9(11):1097–105. doi:10.1016/S1474-4422(10)70209-X.
   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). doi:10.3390/ijerph13090890.
   Web of Science ®Google Scholar
• Schmidt NJ, Lennette EH, Ho HH. An apparently new enterovirus isolated from patients with disease of the central nervous system. J Infect Dis. 1974;129(3):304–09. doi:10.1093/infdis/129.3.304.
   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. doi:10.1016/s0140-6736(05)60789-1.
   PubMed Web of Science ®Google Scholar
• Sun LM, Zheng HY, Zheng HZ, Guo X, He JF, Guan DW, Kang M, Liu Z, Ke CW, Li JS, et al. An enterovirus 71 epidemic in Guangdong Province of China, 2008: epidemiological, clinical, and virogenic manifestations. Jpn J Infect Dis. 2011;64(1):13–18.
   PubMed Web of Science ®Google Scholar
• Solomon T, Lewthwaite P, Perera D, Cardosa MJ, McMinn P, Ooi MH. Virology, epidemiology, pathogenesis, and control of enterovirus 71. Lancet Infect Dis. 2010;10(11):778–90. doi:10.1016/S1473-3099(10)70194-8.
   PubMed Web of Science ®Google Scholar
• Esposito S, Principi N. Hand, foot and mouth disease: current knowledge on clinical manifestations, epidemiology, aetiology and prevention. Eur J Clin Microbiol Infect Dis. 2018;37(3):391–98. doi:10.1007/s10096-018-3206-x.
   PubMed Web of Science ®Google Scholar
• Koh WM, Bogich T, Siegel K, Jin J, Chong EY, Tan CY, Chen MI, Horby P, Cook AR. The epidemiology of hand, foot and mouth disease in Asia: a systematic review and analysis. Pediatr Infect Dis J. 2016;35(10):e285–e300. doi:10.1097/INF.0000000000001242.
   PubMed Web of Science ®Google Scholar
• Zhang J. Trend of epidemics and variation of pathogens of hand, foot and mouth disease in China: a dynamic series analysis, 2008-2017. Chin J Epidemiol. 2019;40(2):147–54. doi:10.3760/cma.j.0254-6450.2019.02.005.
   Google Scholar
• Gu W, Zeng G, Hu YM, Hu YS, Zhang Y, Hu YL, Wang Y, Li JX, Zhu FC. A comparative analysis of immunogenicity and safety of an enterovirus 71 vaccine between children aged 3-5 years and infants aged 6-35 months. Expert Rev Vaccines. 2018;17(3):257–62. doi:10.1080/14760584.2018.1430572.
   PubMed Web of Science ®Google Scholar
• Wang XF, Lu J, Liu XX, Dai T. Epidemiological features of hand, foot and mouth disease outbreaks among Chinese preschool children: a meta-analysis. Iran J Public Health. 2018;47:1234–43.
   PubMed Web of Science ®Google Scholar
• Zheng YM, Jit M, Wu JT, Yang J, Leung K, Liao QH, Yu HJ. Economic costs and health-related quality of life for hand, foot and mouth disease (HFMD) patients in China. PLoS One. 2017;12(9):e0184266. doi:10.1371/journal.pone.0184266.
   PubMed Web of Science ®Google Scholar
• Lee MS, Tseng FC, Wang JR, Chi CY, Chong P, Su IJ. Challenges to licensure of enterovirus 71 vaccines. PLoS Negl Trop Dis. 2012;6(8):e1737. doi:10.1371/journal.pntd.0001737.
   PubMed Web of Science ®Google Scholar
• Yi EJ, Shin YJ, Kim JH, Kim TG, Chang SY. Enterovirus 71 infection and vaccines. Clin Exp Vaccine Res. 2017;6(1). doi:10.7774/cevr.2017.6.1.4.
   PubMedGoogle Scholar
• Zhu FC, Xu WB, Xia JL, Liang ZL, Liu Y, Zhang XF, Tan XJ, Wang L, Mao QY, Wu YM, et al. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med. 2014;370(9):818–28. doi:10.1056/NEJMoa1304923.
   PubMed Web of Science ®Google Scholar
• Li YP, Liang ZL, Xia JL, Wu JY, Wang L, Song LF, Mao QY, Wen SQ, Huang RG, Hu YS, et al. Immunogenicity, safety, and immune persistence of a novel inactivated human enterovirus 71 vaccine: a phase II, randomized, double-blind, placebo-controlled trial. J Infect Dis. 2014;209(1):46–55. doi:10.1093/infdis/jit429.
   PubMed Web of Science ®Google Scholar
• Li JX, Song YF, Wang L, Zhang XF, Hu YS, Hu YM, Xia JL, Li J, Zhu FC. Two-year efficacy and immunogenicity of Sinovac enterovirus 71 vaccine against hand, foot and mouth disease in children. Expert Rev Vaccines. 2016;15(1):129–37. doi:10.1586/14760584.2016.1096782.
   PubMed Web of Science ®Google Scholar
• Yang B, Wu P, Wu JT, Lau EHY, Leung GM, Yu H, Cowling BJ. Seroprevalence of enterovirus 71 antibody among children in China: a systematic review and meta-analysis. Pediatr Infect Dis J. 2015;34(12):1399–406. doi:10.1097/INF.0000000000000900.
   PubMed Web of Science ®Google Scholar
• Chinese Center for Disease Control and Prevention (CDC). Technical guidelines for the use of inactivated enterovirus 71 vaccines. Beijing,China: Immunization planning center; 2016 June 6 [accessed 2021 Sept 20]. https://www.chinacdc.cn/zxdt/201606/t20160608_131032.html.
   Google Scholar
• Zhang ZW, Liang ZL, Zeng J, Zhang JK, He P, Su JL, Zeng YM, Fan RF, Zhao D, Ma WJ, et al. Immunogenicity and safety of an inactivated enterovirus 71 vaccine administered simultaneously with hepatitis B vaccine and group a meningococcal polysaccharide vaccine: a phase 4, open-label, single-center, randomized, noninferiority trial. J Infect Dis. 2019;220(3):392–99. doi:10.1093/infdis/jiz129.
   PubMed Web of Science ®Google Scholar
• Yang XM. A review of combined immunization: current research situation and its promising future. Chin J Epidemiol. 2020;41(1):120–26. doi:10.3760/cma.j.0254-6450.2020.01.022.
   Google Scholar
• Stucke K, Kieser M. A general approach for sample size calculation for the three-arm ‘gold standard’ non-inferiority design. Stat Med. 2012;31(28):3579–96. doi:10.1002/sim.5461.
   PubMed Web of Science ®Google Scholar
• Hu YM, Wang X, Wang JZ, Wang L, Zhang YJ, Chang L, Liang ZL, Xia JL, Dai QG, Hu YL, 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. 2013;20(12):1805–11. doi:10.1128/CVI.00491-13.
   PubMed Web of Science ®Google Scholar
• Chu Y, Lu YZ, Tao H, Wang B, Wang Y, Wang SQ, Qin J, Xu WQ. Safety and immunogenicity of domestic combined live attenuated measles, mumps and rubella vaccine. Chin J Biol. 2011;24(6):707–10. doi:10.13200/j.cjb.2011.06.88.chuy.003.
   Google Scholar
• Xu HJ, Li W, Xia JH, Tao H, Fang HH, Li YJ, Chu Y, Ma FB, Xu WQ, Wang SQ. Adverse reaction and immunogenicity induced by domestic freeze-dried live attenuated measles-mumps-rubella combined vaccine. Chin J Biol. 2008;21(12):1111–14. doi:10.13200/j.cjb.2008.12.84.xuhj.011.
   Google Scholar