1,070
Views
2
CrossRef citations to date
0
Altmetric
Research Papers

Post-marketing safety surveillance conducted in Korea (2008–2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™)

, , , , &
Pages 2590-2594 | Received 13 Jan 2016, Accepted 09 May 2016, Published online: 05 Aug 2016

References

  • Parashar UD, Gibson CJ, Bresee JS, Glass RI. Rotavirus and severe childhood diarrhea. Emerg Infect Dis 2006; 12:304-6; PMID:16494759; http://dx.doi.org/10.3201/eid1202.050006
  • CDC. Reduction in rotavirus after vaccine introduction—United States, 2000–2009. MMWR 2009; 58:1146-9; PMID:19847149
  • Orenstein EW, Fang ZY, Xu J, Liu C, Shen K, Qian Y, Jiang B, Kilgore PE, Glass RI. The epidemiology and burden of rotavirus in China: a review of the literature from 1983 to 2005. Vaccine 2007; 25:406-13; PMID:16956700; http://dx.doi.org/10.1016/j.vaccine.2006.07.054
  • Richardson V, Parashar U, Patel M. Childhood diarrhea deaths after rotavirus vaccination in Mexico. N Engl J Med 2011; 365:772-3; PMID:21864191; http://dx.doi.org/10.1056/NEJMc1100062
  • Pediatric ROTavirus European CommitTee (PROTECT). The paediatric burden of rotavirus disease in Europe. Epidemiol Infect 2006; 134:908-16; PMID:16650331; http://dx.doi.org/10.1017/S0950268806006091
  • Korea Centers for Disease Control and Prevention. Molecular epidemiology of group A rotavirus infection in Korea. Public Health Weekly Report 2008; 20:325-8
  • Kang JO, Kim MN, Kim J, Suh HS, Yoon Y, Jang S, Chang C, Choi S, Nyambat B, Kilgore PE. Epidemiologic trends of rotavirus infection in the Republic of Korea, July 1999 through June 2002. Ann Lab Med 2002; 23:382-387
  • Seo JK, Sim JG. Overview of rotavirus infections in Korea. Pediatr Int 2000; 42:406-10; PMID:10986878; http://dx.doi.org/10.1046/j.1442-200x.2000.01250.x
  • Kim JS, Kang JO, Cho SC, Jang YT, Min SA, Park TH, Nyambat B, Jo DS, Gentsch J, Bresee JS, et al. Epidemiological profile of rotavirus infection in the Republic of Korea: results from prospective surveillance in the Jeongeub District, 1 July 2002 through 30 June 2004. J Infect Dis 2005; 192:S49-56; PMID:16088805; http://dx.doi.org/10.1086/431506
  • Kim MJ, Jeong HS, Kim SG, Lee SM, Kim SH, Kee HY, Jo EH, Park HJ, Ha DR, Kim ES, et al. Diversity of Rotavirus strains circulated in Gwangju, Republic of Korea. Osong Public health and research perspectives 2014; 5(6):364-9; PMID:25562046; http://dx.doi.org/10.1016/j.phrp.2014.10.004
  • Kim DS, Lee TJ, Kang JH, Kim JH, Lee JH, Ma SH, Kim SY, Kim HM, Shin SM. Immunogenicity and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy infants in Korea. Pediatr Infect Dis J 2008; 27:177-8; PMID:18174862; http://dx.doi.org/10.1097/INF.0b013e31817d877a
  • Kim JS, Bae CW, Lee KY, Park MS, Choi YY, Kim KN, Kim JD, Park WS, Sin JB, Kim EA, et al. Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study. Hum Vaccine Immunother 2012; 8:806-12; http://dx.doi.org/10.4161/hv.19853
  • Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, et al. Human Rotavirus Vaccine Study Group. Safety and effi¬cacy of an attenuated vaccine against severe rotavi¬rus gastroenteritis. N Engl J Med 2006; 354:11-22; PMID:16394298; http://dx.doi.org/10.1056/NEJMoa052434
  • Madhi SA, Kirsten M, Louw C, Bos P, Aspinall S, Bouckenooghe A, Neuzil KM, Steele AD. Efficacy and immunogenicity of two or three dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial. Vaccine 2012; 30:A44-51; PMID:22520136; http://dx.doi.org/10.1016/j.vaccine.2011.08.080
  • Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, Meurice F, Han HH, Damaso S, Bouckenooghe A. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet 2007; 370:1757-63; PMID:18037080; http://dx.doi.org/10.1016/S0140-6736(07)61744-9
  • Shim JO, Than VT, Ryoo E, Lim I, Yoon Y, Kim K, Chung SI, Kim W. Distribution of Rotavirus G and P Genotypes Approximately Two Years Following the Introduction of Rotavirus Vaccines in South Korea. J Med Virol 2013; 85:1307-12; PMID:23595867; http://dx.doi.org/10.1002/jmv.23586
  • Choi UY, Lee SY, Ma SH, Jang YT, Kim JY, Kim HM, Kim JH, Kim DS, Kim YS, Kang JH. Epidemiological changes in rotavirus gastroenteritis in children under 5 years of age after the introduction of rotavirus vaccines in Korea. Eur J Pediatr 2013; 172:947-52; PMID:23443155; http://dx.doi.org/10.1007/s00431-013-1974-y
  • Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, et al. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother 2014; 10(8):2276-83; PMID:25424932; http://dx.doi.org/10.4161/hv.29280
  • Narang A, Bose A, Pandit AN, Dutta P, Kang G, Bhattacharya SK, Datta SK, Suryakiran PV, Delem A, Han HH, et al. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants. Hum Vaccin 2009; 5:414-9; PMID:19276664; http://dx.doi.org/10.4161/hv.5.6.8176
  • Cheuvart B, Friedland LR, Abu-Elyazeed R, Han HH, Guerra Y, Verstraeten T. The human rotavi¬rus vaccine RIX4414 in infants: a review of safety and tolerability. Pediatr Infect Dis J 2009; 28:225-32; PMID:19209095; http://dx.doi.org/10.1097/INF.0b013e31819715fa
  • Buyse H, Vinals C, Karkada N, Han H. The human rotavirus vaccine Rotarix™ in infants. An integrated analysis of safety and reactogenicity. Hum Vaccin Immunother 2014; 10(1):19-24; PMID:24047799; http://dx.doi.org/10.4161/hv.26476
  • Rotarix Korean Prescribing Information. Available at: https://www.gsk-korea.co.kr/upload/product/rotarix_20160318[1].pdf [accessed on 29 Mar, 2016] [In Korean]
  • Vesikari T, Karvonen A, Bouckenooghe A, Suryakiran PV, Smolenov I, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants. Vaccine 2011; 29(11):2079-84; PMID:21238572; http://dx.doi.org/10.1016/j.vaccine.2011.01.004
  • Dokgo YC. Vaccination Guideline. 5 ed. Seocho World Office, Seo Cho-dong Seo Cho-Gu Seoul Korea: Korea Society of Pediatrics 2002.
  • Adverse Reaction Terminology WHO-ART. Uppsala (Sweden): The Uppsala Monitoring Center. Available at: http://www.umc-products.com/graphics/28010.pdf [Accessed on 29 Mar 2016]