우리나라 영아에서 주사용 소아마비 백신(PoliorixTM)의 안전성 및 이상반응에 대한 연구 Safety and Reactogenicity of the Inactivated Poliomyelitis Vaccine (PoliorixTM) in Korea (2006-2012)원문보기
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(Poliorix$^{TM}$)의 안전성 및 이상반응을 우리나라 영아들을 대상으로 알아보고자 한다. 방법: 2006년부터 2012년까지 6년 동안 다기관공동연구로 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, 이중 가장 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 연구 종료 이전에 호전되었다. 결론: 6년 동안의 시판 후 조사에서, 건강한 우리나라 영아들을 대상으로 한 주사용 소아마비 사백신(Poliorix$^{TM}$) 접종은 국내 건강한 소아에서 안전하고 내약성이 충분하였다.
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(Poliorix$^{TM}$)의 안전성 및 이상반응을 우리나라 영아들을 대상으로 알아보고자 한다. 방법: 2006년부터 2012년까지 6년 동안 다기관공동연구로 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, 이중 가장 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 연구 종료 이전에 호전되었다. 결론: 6년 동안의 시판 후 조사에서, 건강한 우리나라 영아들을 대상으로 한 주사용 소아마비 사백신(Poliorix$^{TM}$) 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 Poliorix$^{TM}$ following its introduction in 2006. Methods: In this open, multicenter study, the vaccine was admi...
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 Poliorix$^{TM}$ 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 Poliorix$^{TM}$ was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.
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 Poliorix$^{TM}$ 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 Poliorix$^{TM}$ was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.
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제안 방법
In this study, Poliorix™ was administered according to the current practice of Korean doctors in reference to the guidebook of the Korean Pediatric Society8) and as indicated in the Korean label7): For primary vaccination, three vaccine doses were given to infants at 2, 4 and 6 months of age and administered concomittently DTaP vaccine. All subjects were administered Hib (Haemophilus influenzae tybe b) vaccine and pneumococcal conjugate vacine within two weeks; for the booster vaccination schedule, a single dose was given to children aged 4-6 years with DTaP vaccine concomittently. The type of vaccines to administered concomittently were the same according to pre-determined protocol in all participating centers.
In this study, All subjects administered inactivated poliovaccine (Poliorix™ ) with DTaP vaccine in primary vaccination.
This study was conducted to assess the safety profile of Poliorix™ which was approved for use in the Republic of Korea in late 2006.
대상 데이터
A total of 639 subjects were enrolled between August 2006 and February 2012 and were included in the total vaccinated cohort. Of these, 617 subjects received the vaccine as primary vaccination; the remaining subjects received the vaccine as a booster dose.
성능/효과
Data from this study indicate that Poliorix™ is well tolerated for both primary and booster administration by healthy Korean infants, when administered according to prescribing information as part of routine clinical practice.
In conclusion, this six year surveillance to monitor safety and reactogenicity of Poliorix™ in Korea reports an acceptable safety profile of the vaccine when administered according to the current practice of Korean doctors, as indicated in the guidebook of the Korean Pediatric Society and the Korean label.
The percentages of children with any solicited symptom and specifically, local (pain, redness and swelling) and general symptoms (fever, axillary; irritability, drowsiness, loss of appetite and gastrointestinal condition) during the 7-day follow-up period were reported with 95% confidence interval (CI). Occurrences of unsolicited adverse events (classified by the Medical Dictionary for Regulatory Activities Primary System Organ Class and Preferred Term) (AEs) during the 7-day follow-up period and 31-day follow-up period were reported.
참고문헌 (14)
The Global Polio Eradication Initiative. Polio this week: data and monitoring. [Cited 2012 Oct 12]. Available from http://www.polioeradication.org/Dataandmonito ring/Poliothisweek.aspx.
World Health Organization. Poliomyelitis: Fact Sheet Number 114. Oct 2011. [cited 2012 Oct 12]. Available from: http://www.who.int/mediacentre/factsheets/fs114/en/.
Minor P. Vaccine-derived poliovirus (VDPV): Impact on poliomyelitis eradication. Vaccine 2009;27:2649？52.
Centers for Disease Control and Prevention. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding routine poliovirus vaccination. MMWR Morb Mortal Wkly Rep 2009;58:829-30.
World Health Organization. Immunization profile: Republic of Korea. 2012. [cited 2012 Oct 12]. Available from: http://apps.who.int/immunization_monitoring/ en/globalsummary/countryprofileresult.cfm.
The Korean Pediatric Society. Poliovirus vaccine. In: Lee HJ, ed. Immunization Guideline. 6th ed. Seoul: The Korean Pediatric Society 2008:1-4.
World Health Organization. $Poliorix^{TM}$ : WHO Package Insert. 2010.[cited 2012 Oct 29] Available from: http: //www.who.int/immunization_standards/vaccine_quali ty/Poliorix_package_insert_en_june10.pdf.
Advisory Committee on Immunization Program. Epidemiology and prevention of vaccine-preventable disease, Korea Center for Disease Control and Prevention, 2005:123-37.
Kim SJ, Kim SH, Jee YM, Kim JS. Vaccine associated paralytic poliomyelitis: A case report of flaccid monoparesis after oral polio vaccine. J Korean Med Sci 2007;22:362-4.
Tebbens RJD, Pallansch MA, Kew OM, Caceres VM, Jafari H, Cochi SL, et al. Risks of paralytic disease due to wild or vaccine-derived poliovirus after eradication. Risk Anal 2006;26:1471-505.
Li Y, Li R, Ying Z, Wang J, Pan G, Chen X, et al. Immunogenicity and safety of an inactivated poliovirus vaccine in Chinese infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). The Melbourne, Australia, 16-19 November 2011.
Lee SY, Hwang HS, Kim JH, Kim HH, Lee HS, Chung EH, et al. Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the republic of Korea. Vaccine 2011;29:1551-7.
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