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Safety and Reactogenicity of the Inactivated Poliomyelitis Vaccine (PoliorixTM) in Korea (2006-2012)

Sin, JB; Park, MS; Ma, SH; Choi, YY; Shin, SM; Kim, WD; Kuriyakose, S; Ulianov, L; Hardt, K
Soa kamyŏm, 20(3):139-146, 2013
Journal Title
Soa kamyŏm; Korean journal of pediatric infectious diseases; 소아감염
목적: 한국은 2000년에 소아마비 무발생국가로 공인되었으며, WHO의 권고에 의해 2005년부터는 경구용소아마비 생백신 대신 주사용 사백신을 사용하기 시작했다.본 연구는 2006년부터 국내에서 사용되기 시작한 주사용 소아마비 백신(PoliorixTM)의 안전성 및 이상반응을우리나라 영아들을 대상으로 알아보고자 한다.

방법: 2006년부터 2012년까지 6년 동안 다기관공동 연구로 조사하였으며, 2, 4, 6개월의 기초접종과 4-6세의 추가 접종 후 7일 이내 및 31일 이내의 이상반응 및 안전성에 대해 조사하였다.

결과: 총 639명 중 등록대상자 중 617명은 기초접종, 22명은 추가접종을 실시하였으며, 639명 중 73명(11.4%)에서 명시되지 않은 이상반응을 보고하였으며, 이중가장 많은 증상은 상기도 감염증상으로 접종 후 7일 이내에 639명 중 16명(2.5%)에서 보고되었다. 1명에서 grade 3 이상의 장염증상을 보고하였으며, 11명(1.7%)에서 중대한 이상반응을 보고하였으나, 이들은 모두 연구종료 이전에 호전되었다.

결론: 6년 동안의 시판 후 조사에서, 건강한 우리나라 영아들을 대상으로 한 주사용 소아마비 사백신(PoliorixTM) 접종은 국내 건강한 소아에서 안전하고 내약성이 충분하였다.

Objective: As per the requirement of Korean Food and Drug Administration, this post-marketing surveillance was conducted in Korea to evaluate the safety and reactogenicity of PoliorixTM following its introduction in 2006.

Methods: In this open, multicenter study, the vaccine was administered as per the current practice of Korean doctors and in reference to the guidebook by the Korean Pediatric Society and as indicated in the Korean label which was as follows - for primary vaccination three doses were given to infants at ages 2, 4 and 6 months whereas, for the booster dose a single dose was given to children aged 4-6 years. Safety data during this six year surveillance was collected using diary cards which were distributed to the parents to record adverse events.

Results: A total of 639 subjects were enrolled into the study. Of these, 617 subjects and 22 subjects received the vaccine as a primary and booster dose, respectively. At least one unsolicited symptom was reported in 11.4% (73/639) of the subjects during the 7-day follow-up period; upper respiratory tract infection (2.5%;16/639) was the most frequently reported unsolicited symptom. One subject reported at least one unsolicited symptom (gastroenteritis) of grade 3 intensity within the 31-day post-vaccination period. Approximately 1.7% (11/639) of subjects reported 13 serious adverse events (SAEs). All SAEs were resolved by the end of the study.

Conclusion: In Korea, primary and booster vaccination with PoliorixTM was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.
PoliomyelitisInactivated polio vaccineSafetyReactogenicityKorea
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