Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months–55 years

References

• Borrow R, Alarcon P, Carlos J, Caugant DA, Christensen H, Debbag R, De Wals P, Echaniz-Aviles G, Findlow J, Head C, et al. The global meningococcal initiative: global epidemiology, the impact of vaccines on meningococcal disease and the importance of herd protection. Expert Rev Vaccines. 2017;16(4):313–28. doi:10.1080/14760584.2017.1258308.
   PubMed Web of Science ®Google Scholar
• Pelton SI. The global evolution of meningococcal epidemiology following the introduction of meningococcal vaccines. J Adolesc Health. 2016;59(2 Suppl):S3–S11. doi:10.1016/j.jadohealth.2016.04.012.
   PubMed Web of Science ®Google Scholar
• Meningococcal vaccines. WHO position paper, November 2011. Wkly Epidemiol Rec. 2011;86(47):521–39.
   PubMedGoogle Scholar
• Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. In: Hamborsky J, Kroger A, Wolfe S, editors. Chapter 14: meningococcal disease. Washington (D.C): Public Health Foundation; 2015. p. 231–246.
   Google Scholar
• European Centre for Disease Prevention and Control. Invasive meningococcal disease. In: ECDC. Annual epidemiological report for 2015. Stockholm (Sweden): ECDC; 2017. [accessed 2019 Jan 10]. http://ecdc.europa.eu/sites/portal/files/documents/AER_for_2015-meningococcal-disease.pdf
   Google Scholar
• Centers for Disesease Control and Prevention. Enhanced meningococcal disease surveillance report. 2016. [accessed 2019 Jan 14]. https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report.pdf
   Google Scholar
• Borrow R, Lee JS, Vazquez JA, Enwere G, Taha MK, Kamiya H, Kim HM, Jo DS. Global meningococcal initiative. 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.
   PubMed Web of Science ®Google Scholar
• Heo JY. Meningococcal disease in Korea: an epidemiologic study of the underestimated infectious disease. Infect Chemother. 2016;48(1):51–53. doi:10.3947/ic.2016.48.1.51.
   PubMed Web of Science ®Google Scholar
• Korea Centers for Disease Control and Prevention. Disease surveillance statistics. 2018. [accessed 2018 Aug 8]. http://www.cdc.go.kr/CDC/cms/cmsFileDownload.jsp?fid=9145&cid=123024&fieldName=attach1&index=1
   Google Scholar
• Lee H, Seo Y, Kim KH, Lee K, Choe KW. Prevalence and serogroup changes of Neisseria meningitidis in South Korea, 2010–2016. Sci Rep. 2018;8(1):5292. doi:10.1038/s41598-018-23365-8.
   PubMedGoogle Scholar
• Highlights of prescribing information. Menveo. 2018. [accessed 2019 July 31]. http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm201349.pdf
   Google Scholar
• Abdelnour A, Silas PE, Lamas MR, Aragon CF, Chiu NC, Chiu CH, Acuna TH, Castrejon Tde L, Izu A, Odrljin T, et al. Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants. Vaccine. 2014;32(8):965–72. doi:10.1016/j.vaccine.2013.12.034.
   PubMed Web of Science ®Google Scholar
• Klein NP, Reisinger KS, Johnston W, Odrljin T, Gill CJ, Bedell L, Dull P. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J. 2012;31(1):64–71. doi:10.1097/INF.0b013e31823dce5c.
   PubMed Web of Science ®Google Scholar
• Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010;28(50):7865–72. doi:10.1016/j.vaccine.2010.09.092.
   PubMed Web of Science ®Google Scholar
• Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, et al. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010;28(18):3171–79. doi:10.1016/j.vaccine.2010.02.045.
   PubMed Web of Science ®Google Scholar
• Gill CJ, Baxter R, Anemona A, Ciavarro GL, Dull PM. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo®) or Menactra® among healthy adolescents. Hum Vaccin. 2010;6(11):881–87. doi:10.4161/hv.6.11.12849.
   PubMed Web of Science ®Google Scholar
• Jackson L, Baxter R, Reisinger K, Karsten A, Shah J, Bedell L, Dull P. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis. 2009;49(1):e1–e10. doi:10.1086/599117.
   PubMed Web of Science ®Google Scholar
• Korea Centers for Disease Control and Prevention. National Immunization Program & International Cooperation 2017. [accessed 2019 Jul 31]. http://www.ghsagenda.org/docs/default-source/default-document-library/seventieth-world-health-assembly/national-immunization-program-international-cooperation—kcdc.pdf
   Google Scholar
• Keshavan P, Pellegrini M, Vadivelu-Pechai K, Nissen M. An update of clinical experience with the quadrivalent meningococcal ACWY-CRM conjugate vaccine. Expert Rev Vaccines. 2018;17(10):865–80. doi:10.1080/14760584.2018.1521280.
   PubMed Web of Science ®Google Scholar
• Lee HJ, Chung MH, Kim WJ, Hong YJ, Choi KM, Lee J, Oh CE, Welsch JA, Kim KH, Hong KB, et al. Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults. Int J Infect Dis. 2014;28:204–10. doi:10.1016/j.ijid.2014.06.008.
   PubMed Web of Science ®Google Scholar
• Huang LM, Chiu NC, Yeh SJ, Bhusal C, Arora AK. Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2–18 years in Taiwan: results of an open label study. Vaccine. 2014;32(40):5177–84. doi:10.1016/j.vaccine.2014.07.063.
   PubMed Web of Science ®Google Scholar
• Lalwani S, Agarkhedkar S, Gogtay N, Palkar S, Agarkhedkar S, Thatte U, Vakil H, Jonnalagedda R, Pedotti P, Hoyle M, et al. Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years. Int J Infect Dis. 2015;38:36–42. doi:10.1016/j.ijid.2015.07.003.
   PubMed Web of Science ®Google Scholar
• Klein NP, Shepard J, Bedell L, Odrljin T, Dull P. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers. Vaccine. 2012;30(26):3929–36. doi:10.1016/j.vaccine.2012.03.080.
   PubMed Web of Science ®Google Scholar
• Nolan TM, Nissen MD, Naz A, Shepard J, Bedell L, Hohenboken M, Odrljin T, Dull PM. Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age. Hum Vaccin Immunother. 2014;10(2):280–89. doi:10.4161/hv.27051.
   PubMed Web of Science ®Google Scholar
• Tregnaghi M, Lopez P, Stamboulian D, Grana G, Odrljin T, Bedell L, Dull PM. Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers. Int J Infect Dis. 2014;26:22–30. doi:10.1016/j.ijid.2014.03.1390.
   PubMed Web of Science ®Google Scholar
• Jackson LA, Jacobson RM, Reisinger KS, Anemona A, Danzig LE, Dull PM. A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr Infect Dis J. 2009;28(2):86–91. doi:10.1097/INF.0b013e31818a0237.
   PubMed Web of Science ®Google Scholar
• Gasparini R, Conversano M, Bona G, Gabutti G, Anemona A, Dull PM, Ceddia F. Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis vaccine in adolescents and young adults. Clin Vaccine Immunol. 2010;17(4):537–44. doi:10.1128/CVI.00436-09.
   PubMed Web of Science ®Google Scholar
• Stamboulian D, Lopardo G, Lopez P, Cortes-Barbosa C, Valencia A, Bedell L, Karsten A, Dull PM. Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis. 2010;14(10):e868–75. doi:10.1016/j.ijid.2010.03.017.
   PubMed Web of Science ®Google Scholar
• Myers TR, McNeil MM, Ng CS, Li R, Lewis PW, Cano MV. Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010–2015. Vaccine. 2017;35(14):1758–63. doi:10.1016/j.vaccine.2017.02.030.
   PubMed Web of Science ®Google Scholar