Protective Field Efficacy Study of Influenza Vaccines for Korean Children and Adolescent in 2010-2011 Season

한국의 소아 청소년에서 인플루엔자 백신의 효능평가

  • Kim, Seung Youn (Department of Pediatrics, Korean Cancer Center Hospital) ;
  • Kim, Nam Hee (Department of Pediatrics, Inje University College of Medicine, Ilsan Paik Hospital) ;
  • Eun, Byung Wook (Department of Pediatrics, Graduate School of Medicine, Gachon University of Medicine and Science) ;
  • Kim, So Hee (Department of Pediatrics, Samhospital) ;
  • Park, Ki Won (Love Neighbor's Pediatric Clinic) ;
  • Jang, Hyun Oh (Hanbyulsoa Pediatric Clinic) ;
  • Kang, Eun Kyeong (Department of Pediatrics, Korea University College of Medicine) ;
  • Kim, Dong Ho (Department of Pediatrics, Korean Cancer Center Hospital)
  • 김승연 (원자력병원 소아청소년과) ;
  • 김남희 (인제대학교 일산백병원 소아청소년과) ;
  • 은병욱 (가천의과학대학교 가천대길병원 소아청소년과) ;
  • 김소희 (샘안양병원) ;
  • 박기원 (이웃사랑 소아청소년과 의원) ;
  • 장현오 (한별 소아청소년과의원) ;
  • 강은경 (동국대학교 일산병원 소아청소년과) ;
  • 김동호 (원자력병원 소아청소년과)
  • Received : 2012.08.21
  • Accepted : 2012.10.09
  • Published : 2012.12.25

Abstract

Purpose : We conducted a prospective comparative clinical study to determine the field efficacy of the 2010-2011 influenza vaccines [Influenza virus strains; A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), B/Brisbane/60/2008] in healthy Korean children under 18 years of age. Methods : In this study, we enrolled subjects aged between 6 months and 18 years and divided them into 2 study groups: a group who received the influenza vaccines (407 subjects), and a control group who did not receive the influenza vaccines (230 subjects). Ours was a multicenter study that involved 7 hospitals, including the Korea Cancer Center Hospital. The study was conducted between September 2010 and February 2011. We collected nasal wash or throat swab samples from subjects who presented with acute febrile respiratory or influenza-like illnesses at the hospital. We used PCR to confirm the presence of the influenza virus in the respiratory samples and characterize the virus type. Results : In this study, we collected 22 respiratory samples from the influenza-vaccinated group and found 3 cases of influenza virus infection. Similarly, we collected 21 samples from the control group and found 12 cases of influenza virus infection among 10 subjects during the study period. We determined the field efficacy of the 2010-2011 seasonal influenza vaccines to be 83.2% in healthy Korean children and adolescents. Conclusion : In this study, we determined the field efficacy of the 2010-2011 seasonal influenza vaccines in healthy Korean children and adolescents. We found that the field efficacy of 2010-2011 seasonal influenza vaccines was adequate.

목 적 : 소아청소년을 대상으로 2010-2011 인플루엔자 백신의 야외 효능을 확인하고자 하였다. 방 법 : 2010년 9월에서 2011년 2월까지 소아 청소년을 대상으로 서울 경기지역의 7개 병원과 1개 초등학교에서 인플루엔자 백신을 접종한 시험군과 접종하지 않은 대조군을 모집하였다. 급성 발열성 호흡기 질환 증상이 있을시 임상시험기관에 방문하도록 하여 검체를 채취하여 감염여부를 확인하였다. 결 과 : 시험 군 407명 중 3명(0.74%)에서 3건의 신종 H1N1 인플루엔자 바이러스가 검출되었고, 대조군 230명 중 10명(4.35%)에서 12건을 검출하여 9명(3.91%)에서 9건의 신종 H1N1, 3명(1.30%)에서 3건의 H3N2 인플루엔자 바이러스를 검출하였다. 시험군에서의 인플루엔자 발생률은 0.74%, 대조군에서 4.35%였다. 백신의 야외 효능은 83.2%였다. 결 론 : 소아청소년을 대상으로 2010-2011년 인플루엔자 백신의 야외효능은 우수하였음을 확인하였다.

Keywords

References

  1. Glezen WP. Influenza viruses. In; Feigin RD, Cherry JD, Demmler-Harrison GJ, Kaplan SL, editors. Textbook of pediatric infectious diseases. 6th ed. Philadelphia: WB Saunders Co, 2009:2395-413.
  2. Izurieta HS, Thompson WW, Karamarz P, Shay DK, Davis RL, DeStefano F, et al. Influenza and the rates of hospitalization for respiratory disease among infants and young children. N Engl J Med 2000;342:232-9. https://doi.org/10.1056/NEJM200001273420402
  3. Glezen WP, Decker M, Joseph SW, Mercready Jr. RG. Acute respiratory disease associated with influenza epidemics in Houston, 1981–1983. J Infect Dis 1987;155: 1119-26. https://doi.org/10.1093/infdis/155.6.1119
  4. Ki HO, Kwon DH. Korean influenza suveillance report, 2010-2011. PHWR 2011;4:1-20.
  5. Reichert TA, Sugaya N, Fedson DS, Glezen WP, Simonsen L, Tashiro M. The Japanese experience with vaccinating school children against influenza. N Engl J Med 2001; 344:889-96. https://doi.org/10.1056/NEJM200103223441204
  6. Monto AS, Davenport FM, Napier JA, Francis T Jr. Modification of an outbreak of influenza in Tecumseh, Michigan, by vaccination of school children. J Infect Dis 1970;122:16-25. https://doi.org/10.1093/infdis/122.1-2.16
  7. Ruben FL, Inactivated influenza virus vaccines in children. Clin Infect Dis 2004:38:678-88. https://doi.org/10.1086/382883
  8. Hickling J, D'Hondt E, A review of production technologies for influenza virus vaccines, and their suitability for deployment in developing countries for influenza pandemic preparedness. World Health Organization Initiative for Vaccine Research 2006:1-34.
  9. Fedson DS, Pandemic influenza and the global vaccine supply. Clin Infect Dis 2003;36:1552-61. https://doi.org/10.1086/375056
  10. Fedson DS, Measuring protection: efficacy versus effectiveness. Dev Biol Stand 1998;95:195-201.
  11. Osterholm MT, Kelly NS, Sommer A, Belongia EA, Efficacy and effectiveness of influenza vaccines: a systemic review and meta-analysis. Lancet Infect Dis 2012;12: 36-44. https://doi.org/10.1016/S1473-3099(11)70295-X
  12. HK Chang, JH Park, MS Song, TK Oh, SY Kim, CJ Kim, et al. Development of multiplex rt-PCR assays for rapid detection and subtyping of influenza type A viruses from clinical specimens. J Microbiol Biotechnol 2008; 18:1164–9.
  13. Dwyer DE, Smith DW, Catton MG, Barr IG. Laboratory diagnosis of human seasonal and pandemic influenza virus infection. Med J Aust 2006;185:S48-53.
  14. Song JY, Cheong HJ, Woo HJ, Wie SH, Lee JS, Chung MH, et al. Immunogenicity and safety of trivalent inactivated influenza vaccine: a randomized, double-blind, multi-center, phase 3 clinical trial in a vaccine-limited country. J Korean Med Sci 2011;26:191-5. https://doi.org/10.3346/jkms.2011.26.2.191
  15. Song JY, Cheong HJ, Hwang IS, Choi WS, Jo YM, Park DW, et al. Long-term immunogenicity of influenza vaccine among the elderly: risk factors for poor immune response and persistence. Vaccine 2010;28:3929-35. https://doi.org/10.1016/j.vaccine.2010.03.067
  16. Langley JM, Scheifele DW, Quach C, Vanderkooi OG, Ward B, McNeil S, et al. Safety and immunogenicity of 2010–2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12–59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: A PHAC/CIHR Influenza Research Network (PCIRN) study. Vaccine 2012;30:3389-94. https://doi.org/10.1016/j.vaccine.2012.03.046
  17. Smith NM, Bresee JS, Shay DK, Uyeki TM, Cox NJ, Strikas RA. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practice (ACIP). MMWR Recomm Rep 2006;55:1-42.
  18. Hoberman A, Greenberg DP, Paradise JL, Rockette HE, Lave JR, Kearney DH, et al. Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children: a randomized controlled trial. JAMA 2003;290:1608-16.
  19. Neuzil KM, Dupont WD, Wright PF, Edwards KM. Efficacy of inactivated and cold-adapted vaccines against influenza A infection, 1985 to 1990: the pediatric experience. Pediatr Infect Dis J 2001;20:733-40. https://doi.org/10.1097/00006454-200108000-00004
  20. Gruber WC, Taber LH, Glezen WP, Clover RD, Abell TD, Demmler RW, et al. Live attenuated and inactivated influenza vaccine in school-age children. Am J Dis Child 1990;144:595-600.
  21. Ruben FL. Prevention and control of influenza. Role of vaccine. Am J Med 1987;82:31-4.
  22. Meiklejohn G. Viral respiratory disease at Lowry Air Force Base in Denver, 1952-1982. J Infect Dis 1983;148: 775-84. https://doi.org/10.1093/infdis/148.5.775