| The Safety and Immunogenicity of a Trivalent, Live, Attenuated MMR Vaccine, PriorixTM |
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Seung-In Ahn1, Min-Kook Chung1, Jung-Suk Yoo1, Hye-Jeon Chung1, Jae-Kyun Hur2, Young-Kyu Shin3, Jin-Keun Chang1, Sung-Ho Cha4 |
1Department of Pediatrics, Han-il General Hospital, Seoul, Korea
2Department of Pediatrics, College of Medicine, St. Paul's Hospital, Catholic Medical College, Seoul, Korea
3Department of Pediatrics, Ansan Hospital, College of Medicine, Korea University, Ansan, Korea
4Department of Pediatrics, College of Medicine, Kyunghee University, Seoul, Korea |
| MMR(Measles-Mumps-Rubella) 약독화 생백신인 프리오릭스주를 접종한 후 안전성과 유효성의 평가에 관한 연구 |
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안승인1, 정민국1, 유정석1, 정혜전1, 허재균2, 신영규3, 장진근1, 차성호4 |
1한일병원 소아과
2가톨릭대학교 성바오로병원 소아과
3고려대학교 의과대학 안산병원 소아과
4경희대학교 의과대학 소아과학교실 |
Correspondence:
Sung-Ho Cha, Email: sunghocha@khu.ac.kr
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| Abstract |
Purpose
: This multi-center, open-label, clinical study was designed to evaluate the safety and immunogenicity of a trivalent, live, attenuated measles-mumps-rubella(MMR) vaccine, PriorixTM in Korean children.
Methods
: From July 2002 to February 2003, a total of 252 children, aged 12-15 months or 4-6 years, received PriorixTM at four centers : Han-il General Hospital, Kyunghee University Hospital, St. Paul's Hospital at the Catholic Medical College in Seoul, and Korea University Hospital in Ansan, Korea. Only subjects who fully met protocol requirements were included in the final analysis. The occurrence of local and systemic adverse events after vaccination was evaluated from diary cards and physical examination for 42 days after vaccination. Serum antibody levels were measured prior to and 42 days post-vaccination using IgG ELISA assays at GlaxoSmithKline Biologicals (GSK) in Belgium.
Results
: Of the 252 enrolled subjects, a total of 199 were included in the safety analysis, including 103 from the 12-15 month age group and 96 from the 4-6 year age group. The occurrence of local reactions related to the study drug was 10.1 percent, and the occurrence of systemic reactions was 6.5 percent. There were no episodes of aseptic meningitis or febrile convulsions, nor any other serious adverse reaction. In immunogenicity analysis, the seroconversion rate of previously seronegative subjects was 99 percent for measles, 93 percent for mumps and 100 percent for rubella. Both age groups showed similar seroconversion rates. The geometric mean titers achieved, 42 days post- vaccination, were : For measles, in the age group 12-15 months, 3,838.6 mIU/mL [3,304.47, 4,458.91]; in the age group 4-6 years, 1,886.2 mIU/mL [825.83, 4,308.26]. For mumps, in the age group 12-15 months, 956.3 U/mL [821.81, 1,112.71]; in the age group 4-6 years, 2,473.8 U/mL [1,518.94, 4,028.92]. For rubella, in the age group 12-15 months, 94.5 IU/mL [79.56, 112.28]; in the age group 4-6 years, 168.9 IU/mL [108.96, 261.90].
Conclusion
: When Korean children in the age groups of 12-15 months or 4-6 years were vaccinated with GlaxoSmithKline Biologicals' live attenuated MMR vaccine (PriorixTM), adverse events were limited to those generally expected with any live vaccine. PriorixTM demonstrated excellent immunogenicity in this population. |
| Key Words:
Measles-mumps-rubella vaccine , Immunogenicity , Adverse effects |
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