Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children

References

• Centers for Disease Control and Prevention (CDC). Provisional pertussis surveillance report. 2017. [ accessed 2018 Jul 31]. https://www.cdc.gov/pertussis/surv-reporting.html.
   Google Scholar
• Choe YJ, Kim JW, Park YJ, Jung C, Bae GR. Burden of pertussis is underestimated in South Korea: a result from an active sentinel surveillance system. Jpn J Infect Dis. 2014;67:230–32.
   PubMed Web of Science ®Google Scholar
• Kim JH, Choi EH, Park SE, Kim YJ, Jo DS, Kim YK, Eun BW, Lee J, Lee SY, Lee H, et al. Recommended immunization schedule for children and adolescents: immunization guideline (8th edition) released by the Korean pediatric society in 2015. Korean J Pediatr. 2016;59(12):461–65. doi:10.3345/kjp.2016.59.12.461.
   PubMedGoogle Scholar
• Choe YJ, Yang JJ, Park SK, Choi EH, Lee HJ. Comparative estimation of coverage between national immunization program vaccines and non-NIP vaccines in Korea. J Korean Med Sci. 2013;28(9):1283–88. doi:10.3346/jkms.2013.28.9.1283.
   PubMed Web of Science ®Google Scholar
• Korea Centers for Disease Control and Prevention (KCDC). 2013 Korea national immunization survey [in Korean]. [ accessed 2018 May 14]. http://cdc.go.kr/CDC/contents/CdcKrContentView.jsp?cid=71894&menuIds=HOME001-MNU1132-MNU2430-MNU2559-MNU2560.
   Google Scholar
• GSK. INFANRIX-IPV Product Information (Korea). [ accessed 2018 Jul 11]. http://drug.mfds.go.kr/html/bxsSearchDrugProduct.jsp?item_Seq=201003939.
   Google Scholar
• Maman K, Zollner Y, Greco D, Duru G, Sendyona S, Remy V. The value of childhood combination vaccines: from beliefs to evidence. Hum Vaccin Immunother. 2015;11(9):2132–41. doi:10.1080/21645515.2015.1044180.
   PubMed Web of Science ®Google Scholar
• Kim CH, Cha SH, Shin SM, Kim CS, Choi YY, Hong YJ, Chey MJ, Kim KN, Hur JK, Jo DS, et al. Immunogenicity, reactogenicity and safety of a combined DTPa-IPV vaccine compared with separate DTPa and IPV vaccines in healthy Korean infants. Korean J Pediatr Infect Dis. 2010;17(2):156–68. doi:10.14776/kjpid.2010.17.2.156.
   Google Scholar
• Black S, Friedland LR, Schuind A, Howe B. GlaxoSmithKline DTaP- IPV vaccine study group. Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4-6 years. Vaccine. 2006;24(35–36):6163–71. doi:10.1016/j.vaccine.2006.04.001.
   PubMed Web of Science ®Google Scholar
• Black S, Friedland LR, Ensor K, Weston WM, Howe B, Klein NP. Diphtheria-tetanus-acellular pertussis and inactivated poliovirus vaccines given separately or combined for booster dosing at 4–6 years of age. Pediatr Infect Dis J. 2008;27(4):341–46. doi:10.1097/INF.0b013e3181616180.
   PubMed Web of Science ®Google Scholar
• Klein NP, Weston WM, Kuriyakose S, Kolhe D, Howe B, Friedland LR, Van Der Meeren O. An open-label, randomized, multi-center study of the immunogenicity and safety of DTaP-IPV (Kinrix) co-administered with MMR vaccine with or without varicella vaccine in healthy pre-school age children. Vaccine. 2012;30(3):668–74. doi:10.1016/j.vaccine.2011.10.065.
   PubMed Web of Science ®Google Scholar
• Nilsson L, Faldella G, Jacquet JM, Storsaeter J, Silfverdal SA, Ekholm L. A fourth dose of DTPa-IPV vaccine given to 4–6 year old children in Italy and Sweden following primary vaccination at 3, 5 and 11–12 months of age. Scand J Infect Dis. 2005;37(3):221–29. doi:10.1080/00365540410020884.
   PubMed Web of Science ®Google Scholar
• Marshall H, Nolan T, Roberton D, Richmond P, Lambert S, Jacquet JM, Schuerman L. A comparison of booster immunisation with a combination DTPa-IPV vaccine or DTPa plus IPV in separate injections when co-administered with MMR, at age 4-6 years. Vaccine. 2006;24(35–36):6120–28. doi:10.1016/j.vaccine.2006.05.017.
   PubMed Web of Science ®Google Scholar
• Weston WM, Klein NP. Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 2008;7(9):1309–20. doi:10.1586/14760584.7.9.1309.
   PubMed Web of Science ®Google Scholar
• Jacquet JM, Bégué P, Grimprel E, Reinert P, Sandbu S, Silfverdal SA, Faldella G, Nolan T, Lambert S, Richmond P, et al. Safety and immunogenicity of a combined DTPa-IPV vaccine administered as a booster from 4 years of age: a review. Vaccine. 2006;24(13):2440–48. doi:10.1016/j.vaccine.2005.12.009.
   PubMed Web of Science ®Google Scholar
• Daley MF, Yih WK, Glanz JM, Hambidge SJ, Narwaney KJ, Yin R, Li L, Nelson JC, Nordin JD, Klein NP, et al. Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine. Vaccine. 2014;32(25):3019–24. doi:10.1016/j.vaccine.2014.03.063.
   PubMed Web of Science ®Google Scholar
• Ministry of Food and Drug Safety (MFDS). Regulation on safety of medicinal products, etc. [Ordinance of the Prime Minister No.1089, Aug.21, 2014, Partially revised]. 2014 [ accessed 2018 Jul 11]. http://www.mfds.go.kr/eng/eng/index.do?nMenuCode=128&page=3&mode=view&boardSeq=69740.
   Google Scholar
• Choi NK, Park BJ. Adverse drug reaction surveillance system in Korea [in Korean]. J Prev Med Public Health. 2007;40:278–84.
   PubMedGoogle Scholar
• Song H, Yim DS. Problems within the post-marketing surveillance system in Korea: time for a change. Transl Clin Pharmacol. 2016;24(2):63–65. doi:10.12793/tcp.2016.24.2.63.
   Google Scholar
• Ministry of Food and Drug Safety (MFDS). Standard for re-examination of new drugs, etc. [Notification No.2015–79 (Amended by 2015.10.30)]. 2015 [ accessed 2018 Jul 13]. http://www.mfds.go.kr/eng/eng/index.do?nMenuCode=128&page=1&mode=view&boardSeq=71446.
   Google Scholar
• Esposito S, Bianchini S, Dellepiane RM, Principi N. Vaccines and Kawasaki disease. Expert Rev Vaccines. 2016;15(3):417–24. doi:10.1586/14760584.2016.1128329.
   PubMed Web of Science ®Google Scholar
• Phuong LK, Bonetto C, Buttery J, Pernus YB, Chandler R, Felicetti P, Goldenthal KL, Kucuku M, Monaco G, Pahud B, et al. Kawasaki disease and immunisation: A systematic review. Vaccine. 2017;35(14):1770–79. doi:10.1016/j.vaccine.2016.09.033.
   PubMed Web of Science ®Google Scholar
• Uehara R, Belay ED. Epidemiology of Kawasaki disease in Asia, Europe, and the United States. J Epidemiol. 2012;22(2):79–85.
   PubMed Web of Science ®Google Scholar
• World Health Organization (WHO). The use of the WHO-UMC system for standardised case causality assessment. 2005 [ accessed 2018 Jul 13]. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf.
   Google Scholar