| 简述疫苗安全性管理 |
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| 引用本文： | 吴浩飞[综述] 孙亨凡[综述] 孟胜利[审校] 杨晓明[审校]. 简述疫苗安全性管理[J]. 微生物学免疫学进展, 2013, 0(5): 69-74 |
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| 作者姓名： | 吴浩飞[综述] 孙亨凡[综述] 孟胜利[审校] 杨晓明[审校] |
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| 作者单位： | 武汉生物制品研究所有限责任公司,湖北武汉430060 |
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| 摘 要： | 疫苗接种是保护公众健康最有效的措施之一，疫苗可有效降低传染病的发病率和死亡率。与疫苗的有效性评估不同，疫苗的安全性不能直接测定，只能通过有限的疫苗不良事件的相关情况来推断。对疫苗安全性监测的科学理论，全球关注的个案研究，以及注册前有关疫苗的临床试验安全性的相关事宜进行了简介。
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| 关 键 词： | 疫苗 安全性 不良事件 |
A brief introduction to management of vaccine safety |
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| Affiliation: | WU Hao-fei, SUN Heng-fan, MENG Sheng-li, YANG Xiao-ming ( Wuhan Institute of Biological Products Co. , Ltd. , Wuhan 430060, China) |
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| Abstract: | Vaccination is one of the most effective measures to protect puplic health, vaccines can effectively reduce morbidity and mortality for infectious diseases. It is different from a evaluation for vaccine effectiveness, vaccine safety can not be measured directly; it can only be deduced from the related vaccine adverse events. In this review, we will outline the scientific framework for monitoring vaccine safety and will highlight recent case studies of global interest. Issues related to pre-licensure study of vaccine safety in clinical trials will be described briefly. |
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| Keywords: | Vaccine Safety Adverse events |
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