2,409
Views
2
CrossRef citations to date
0
Altmetric
Research Paper

Safety and immunogenicity of a meningococcal B recombinant vaccine when administered with routine vaccines to healthy infants in Taiwan: A phase 3, open-label, randomized study

, , , , , & show all
Pages 1075-1083 | Received 23 Oct 2017, Accepted 05 Jan 2018, Published online: 15 Feb 2018

References

  • Rosenstein NE, Perkins BA, Stephens DS, Popovic T, Hughes JM. Meningococcal disease. N Engl J Med. 2001;344(18):1378–88. doi:10.1056/NEJM200105033441807. PMID:11333996.
  • World Health Organization. WHO position paper. Meningococcal vaccines: polysaccharide and polysaccharide conjugate vaccines. Wkly Epidemiol Rec. 2002;77(40):329–40.
  • World Health Organization. 2015. Meningococcal meningitis. Fact sheet no 141. http://www.who.int/mediacentre/factsheets/fs141/en/; [accessed 6 June 2017].
  • Pelton SI. The global evolution of meningococcal epidemiology following the introduction of meningococcal vaccines. J Adolesc Health. 2016;59(Suppl 2):S3−S11. doi:10.1016/j.jadohealth.2016.04.012. PMID:27449148.
  • Sridhar S, Greenwood B, Head C, Plotkin SA, Safadi MA, Saha S, Taha MK, Tomori O, Gessner BD. Global incidence of serogroup B invasive meningococcal disease: a systematic review. Lancet Infect Dis. 2015;15(11):1334–46. doi:10.1016/S1473-3099(15)00217-0. PMID:26453240.
  • Borrow R, Lee J-S, Vázquez JA, Enwere G, Taha M-K, Kamiya H, Kim HM, Jo DS. Meningococcal disease in the Asia-Pacific region: Findings and recommendations from the Global Meningococcal Initiative. Vaccine. 2016;34(48):5855–62. doi:10.1016/j.vaccine.2016.10.022. PMID:27780631.
  • Martinon-Torres F. Deciphering the Burden of Meningococcal Disease: Conventional and Under-recognized Elements. J Adolesc Health. 2016;59(2 Suppl):S12−20. doi:10.1016/j.jadohealth.2016.03.041. PMID:27449145.
  • Whittaker R, Dias JG, Ramliden M, Kodmon C, Economopoulou A, Beer N, Pastore Celentano L. The epidemiology of invasive meningococcal disease in EU/EEA countries, 2004-2014. Vaccine. 2017;35(16):2034–41. doi:10.1016/j.vaccine.2017.03.007. PMID:28314560.
  • Centers for Disease Control and Prevention. Active bacterial Core surveillance (ABCs) report, Emerging Infections Program Network, Neisseria meningitidis (2015). Available from www.cdc.gov/abcs/reports-findings/survreports/mening15.html; [accessed 2 October 2017].
  • Safadi MA, O'Ryan M, Valenzuela Bravo MT, Brandileone MC, Gorla MC, de Lemos AP, Moreno G, Vazquez JA, Lopez EL, Taha MK, et al. The current situation of meningococcal disease in Latin America and updated Global Meningococcal Initiative (GMI) recommendations. Vaccine. 2015;33(48):6529–36. doi:10.1016/j.vaccine.2015.10.055. PMID:26597036.
  • Centers for Disease Control, R.O.C (Taiwan). Communicable Disease &Prevention. Meningococcal meningitis. 2017. Available from http://www.cdc.gov.tw/english/info.aspx?treeid=E79C7A9E1E9B1CDF&nowtreeid=E02C24F0DACDD729&tid=E3F090F82DB3B457; [accessed 22 September 2017].
  • Toneatto D, Pizza M, Masignani V, Rino R. Emerging experience with meningococcal serogroup B protein vaccines. Expert Rev of Vacc. 2017;16(5):433–51. doi:10.1080/14760584.2017.1308828.
  • O'Ryan M, Stoddard J, Toneatto D, Wassil J, Dull PM. A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs. 2014;74(1):15–30. doi:10.1007/s40265-013-0155-7. PMID:24338083.
  • Parikh SR, Andrews NJ, Beebeejaun K, Campbell H, Ribeiro S, Ward C, White JM, Borrow R, Ramsay ME, Ladhani SN. Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study. Lancet. 2016;388(10061):2775–82. doi:10.1016/S0140-6736(16)31921-3. PMID:28100432.
  • European Medicines Agency. Bexsero. Meningococcal group B Vaccine (rDNA, component, adsorbed). Procedure No. EMEA/H/C/002333. 2012. Available from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002333/WC500137883.pdf; [accessed 10 April 2017].
  • Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012;307(6):573–82. doi:10.1001/jama.2012.85. PMID:22318278.
  • Safadi MAP, Martinon-Torres F, Weckx LY, Moreira Junior ED, da Fonseca Lima EJ, Mensi I, Calabresi M, Toneatto D. Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial. Vaccine. 2017;35(16):2052–9. doi:10.1016/j.vaccine.2017.03.002. PMID:28318767.
  • Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013;381(9869):825–35. doi:10.1016/S0140-6736(12)61961-8. PMID:23324563.
  • Snape MD, Voysey M, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Kieninger D, Prymula R, et al. Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age. Pediatr Infect Dis J. 2016;35(4):e113−23. doi:10.1097/INF.0000000000001056. PMID:26756390.
  • Iro MA, Snape MD, Voysey M, Jawad S, Finn A, Heath PT, Bona G, Esposito S, Diez-Domingo J, Prymula R, et al. Persistence of bactericidal antibodies following booster vaccination with 4CMenB at 12, 18 or 24 months and immunogenicity of a fifth dose administered at 4years of age-a phase 3 extension to a randomised controlled trial. Vaccine. 2017;35(2):395–402. doi:10.1016/j.vaccine.2016.11.009. PMID:27914744.
  • Prymula R, Esposito S, Zuccotti GV, Xie F, Toneatto D, Kohl I, Dull PM. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I). Hum Vaccin Immunother. 2014;10(7):1993–2004. doi:10.4161/hv.28666. PMID:25424809.
  • Lee HJ, Choe YJ, Hong YJ, Kim KH, Park SE, Kim YK, Oh CE, Lee H, Song H, Bock H, et al. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea–A randomised trial. Vaccine. 2016;34(9):1180–6. doi:10.1016/j.vaccine.2016.01.033. PMID:26826544.
  • Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129(6):1307–26. doi:10.1084/jem.129.6.1307. PMID:4977280.
  • Clopper C. J., Pearson E. S. The use of confidence limits illustrated in the case of the binomial. Biometrika. 1934;26(4):404–13. doi:10.1093/biomet/26.4.404.