Pediatric Infection and Vaccine

The Korean Society of Pediatric Infectious Diseases (대한소아감염학회)
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Immunogenicity and Safety of Inactivated Influenza Vaccine in Healthy Korean Children and Adolescent

한국의 건강한 소아청소년을 대상으로 한 인플루엔자 사백신의 면역원성과 안전성 연구

  • Ri, Soohyun (Department of Pediatrics, Korea University Ansan Hospital, Korea University College of Medicine) ;
  • Kim, Mi Jeong (Department of Pediatrics, Gyeonggi Provincial Medical Center Icheon Hospital) ;
  • Kim, Yun-Kyung (Department of Pediatrics, Korea University Ansan Hospital, Korea University College of Medicine)
  • 이수현 (고려대학교 의과대학 안산병원 소아과학교실) ;
  • 김미정 (경기도의료원 이천병원 소아청소년과) ;
  • 김윤경 (고려대학교 의과대학 안산병원 소아과학교실)
  • Received : 2017.09.15
  • Accepted : 2017.10.18
  • Published : 2018.04.25
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Abstract

Purpose: This study aimed to evaluate the immunogenicity and safety of a trivalent inactivated influenza vaccine (TIV) among healthy Korean children and adolescents. Methods: From October to December 2008, 65 healthy patients aged 6 months to 18 years who visited Korea University Ansan Hospital for influenza vaccination were enrolled in this study. We measured the hemagglutinin inhibition antibody titers at baseline and 30 days after vaccinating enrollees with split influenza vaccine and calculated the seroprotection rates, geometric mean titers, and seroconversion rates. Local and systemic adverse events were assessed after vaccination. Results: The seroprotection rates against all three viral strains (A/H1N1, A/H3N2, B) were 87.7%, 89.2%, and 89.2% (${\geq}70%$), respectively; seroconversion rates were 44.6%, 73.8%, and 63.1% (${\geq}40%$), respectively; and seroconversion factors were 4.5, 8.4, and 10.5 (>2.5), respectively. The TIV immunogenicity was acceptable according to the CPMP (Committee for Proprietary Medicinal Products) criteria. Although 48 patients (73.8%) reported one or more adverse events, no severe adverse events such as anaphylaxis and convulsion were observed. Forty-two patients (64.6%) reported a local skin reaction, including redness (29.2%), pain (43.1%), or swelling (41.5%) of the injected site, and 26 (40.0%) reported a systemic reaction: fatigue (23.1%), myalgia (20.0%), headache (10.8%), arthralgia (10.8%), chills (9.2%), or fever (7.7%). Conclusions: This study shows that the immunogenicity of the TIV vaccine is acceptable. As there were no serious adverse events aside from local reactions and mild systemic reactions, this vaccine can be safely used among healthy Korean children and adolescents.

목적: 인플루엔자 유행 예방에 대한 가장 효과적인 방법은 인플루엔자 백신이나 한국의 소아청소년을 대상으로 한 면역원성 및 안전성에 대한 자료가 많지 않다. 이에 본 연구는 국내에서 많이 사용되는 불활성화 3가 백신의 면역원성과 안전성을 확인하고자 하였다. 방법: 2008년 10월부터 12월까지 고려대학교 의료원 안산병원 소아청소년과에 인플루엔자 예방접종을 위해 내원한 건강한 소아청소년 중 임상시험 지원자 65명을 대상으로 하여 접종 전과 접종 후 30일째 혈구응집억제(hemagglutinin inhibition) 항체검사를 시행하고 접종 직후부터 접종 후 7일까지 국소반응과 전신반응을 포함한 이상반응을 관찰하여 기록하도록 하였다. 결과: 분할 인플루엔자 백신의 세 항원(H1N1, H3N2, B) 각각에 대한 접종 후 혈청보호율은 87.7%, 89.2%, 89.2% (${\geq}70%$)였으며 혈청전환율은 44.6%, 73.8%, 63.1% (${\geq}40%$), 혈청전환인자는 3.35, 7.18, 5.13 (>2.5)으로 Committee for Proprietary Medicinal Products (CPMP) 기준을 만족하였다. 전체 피험자 65명 중 48명(73.8%)이 백신 접종 후 이상반응을 보고하였으나 아나필락시스나 경련과 같은 심각한 이상반응은 없었다. 발적(29.2%), 동통(43.1%), 종창(41.5%)과 같은 국소반응을 보고한 피험자는 42명(64.6%)이었고, 권태(23.1%), 근육통(20.0%), 두통(10.8%), 관절통(10.8%), 오한(9.2%), 발열(7.7%) 등과 같은 전신반응을 보고한 피험자는 26명(40.0%)이었다. 결론: 6개월에서 18세까지의 소아청소년을 대상으로 한 불활성화 3가 백신의 면역원성과 안전성에 대한 연구 결과 H1N1, H3N2, B 항원 모두 CPMP 기준에 부합하여 적합한 면역원성이 있는 것으로 나타났으며, 국소반응 및 경미한 전신반응 이외에 심각한 이상반응은 보이지 않아 비교적 안전하다고 판단된다.

Keywords

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