Pediatric Infection and Vaccine

The Korean Society of Pediatric Infectious Diseases (대한소아감염학회)
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Post-marketing Surveillance Study of an Inactivated Split-Virion Influenza Vaccine in Korea

불활화 분할 인플루엔자 백신의 국내 시판 후 조사 연구

  • Received : 2011.04.18
  • Accepted : 2011.06.03
  • Published : 2011.06.25
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Abstract

Purpose : This post-marketing surveillance study (NCT00750360) assessed the safety and reactogenicity of an inactivated, trivalent split-virion influenza vaccine licensed for use in the Korea since 2002. Methods : Eight hundred and eighty three subjects aged 6 months received a single dose of the ${\geq}$ vaccine; an additional dose was administered to those aged <9 years and unprimed with an influenza vaccine. Four hundred and eleven subjects used diary cards to record safety information; this report presents data from these subjects. Incidence of solicited local, general and unsolicited adverse events (4-days and 21-days post-vaccination follow-up periods, respectively) were recorded. Serious adverse events (SAEs) were recorded throughout the study period. Results : Injection site pain (subjects aged <6 years: 12.6% of subjects, ${\geq}$6 years: 34.7%), fever (<6 years: 1.3%) and myalgia (${\geq}$6 years: 13.9%) were the most frequently recorded solicited local and general adverse events. Grade 3 solicited adverse events were reported by ${\leq}$4.0% subjects. No vaccine-related SAEs were recorded (KFDA criteria). Conclusion : Considering the vaccine's well-established immunogenicity and its favourable safety and reactogenicity profile across all age groups and its high coverage rate in Korea, it may be recommended as a candidate to facilitate annual seasonal influenza vaccination for all ages as part of the Korean National Immunization Program.

목 적:본 시판 후 조사(NCT00750360)는 2002년부터 국내에서 사용 허가된 정제불활화 3가 분할 인플루엔자 백신의 안전성 및 반응원성을 평가하기 위하여 시행되었다. 방 법:생후 6개월 이상의 소아 및 성인 피험자 총 883명을 대상으로 평가대상 인플루엔자 백신을 1회 접종하였다. 이전에 인플루엔자에 감염되지 않았거나 인플루엔자 백신을 접종하지 않은 만 9세 미만의 소아의 경우에는 1회의 추가접종을 실시 하였다. 411명의 피험자가 일일 기록카드를 사용하여 안정성 정보를 기록하였으며 본 보고서에는 이들 피험자들로부터 수집된 자료가 포함되어 있다. 전신 및 투여부위에서의 명시된 이상반응 및 명시되지 않은 이상반응의 발생률을 기록하였다(백신접종 후 각각 4일 및 21일 동안 추적 관찰하였음). 또한 연구진행기간 전체에 걸쳐서 중대한 유해사례를 추적 관찰하여 기록하였다. 결 과 : 가장 흔하게 관찰된 전신 및 투여부위에서의 명시된 이상반응은 접종부위 통증(만 6세 미만의 소아: 12.6%, 만 6세 이상의 소아: 34.7%), 발열(만 6세 미만: 1.3%) 그리고 근육통(만 6세 이상: 13.9%) 이었다. 등급 3의 명시된 이상반응은 전체 피험자의 4.0% 이하에서 보고되었다. 한국식품의약품 안전청의 기준에 따라 백신과 인과관계가 없는 중대한 유해사례도 기록하였다. 결 론 : 평가대상 백신의 전 연령대에서의 확립된 면역원성 및 우수한 안정성, 반응원성 프로파일과 국내에서의 높은 접종률을 고려할 때, 본 백신을 국가예방접종사업에 포함시켜 모든 연령대에서 계절성 인플루엔자 예방 접종을 증진시키기 위한 후보백신으로 추천할 수 있을 것이다.

Keywords

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