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논문 기본 정보

자료유형
학술저널
저자정보
저널정보
대한소아감염학회 Pediatric Infection and Vaccine Pediatric Infection and Vaccine 제20권 제3호
발행연도
2013.1
수록면
139 - 146 (8page)

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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.
#Poliomyelitis #Inactivated polio vaccine #Safety #Reactogenicity #Korea

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참고문헌 (14)

참고문헌 신청
Advisory Committee on Immunization Program / 2005 / Epidemiology and prevention of vaccine-preventable disease : 123 ~ 137 google schola Bonnet MC / 2008 / World wide experience with inactivated poliovirus vaccine / Vaccine 26 : 4978 ~ 4983 google schola Centers for Disease Control and Prevention / 2009 / Updated recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding routine poliovirus vaccinatio google schola Dutta A / 2008 / Epidemiology of poliomyelitis-options and update / Vaccine 26 : 5767 ~ 5773 google schola Lee SY / 2011 / Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administ google schola

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