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在日本,天花疫苗LC16m8(LC16-KAKET-SUKEN)于2002年3月重新启动生产,决定仍作为国家储备用疫苗。将减毒牛痘病毒株LC16m8通过细胞培养,制备了天花冻干减毒活疫苗LC16-KAKETSUKEN,用于上市后的监测研究。此研究聚焦于初次接种者和再次接种者的对照比较,研究符合良好药品临床试验规范。对日本陆上自卫队268人(261名男性和7名女性)接种了LC16-KAKETSUKEN,此后对不良反应和有效性进行了评价。268名疫苗接种者中,下列的接种者发生了不良反应(无严重不良反应):196例初次接种者(以前
In Japan, the smallpox vaccine LC16m8 (LC16-KAKET-SUKEN) was restarted in March 2002 and is still being used as a vaccine for national reserves. The attenuated vaccinia virus strain LC16m8 was prepared by cell culture, and the freeze-dried smallpox vaccine LC16-KAKETSUKEN was prepared for post-marketing monitoring. This study focused on the comparison of primary and secondary vaccinates with controlled trials that met good clinical trials of drugs. The LC16-KAKETSUKEN was inoculated into 268 of Japan’s Japan Ground Self-Defense Forces (261 males and 7 females), after which adverse reactions and effectiveness were evaluated. Of the 268 vaccinees, the following vaccinators had an adverse reaction (no serious adverse reactions): 196 initial vaccinates (previously