Objective: To identify post-marketing active surveillance systems for vaccine safety around the world and understand their features and mechanisms, in order to provide guidance for vaccine administration activities in China. Methods: Following the steps of scoping review, literature about active surveillance system for vaccine safety and published by 30 June 2018 were identified by searching electronic databases, including PubMed, Scopus, and Cochrane Library. Grey literature were also sought by exploring relevant websites. Identified literature were screened according to eligibility criteria, and informative data from included literature were then charted. Framework Synthesis and Thematic Analysis were performed to integrate the charted data. Results: 97 pieces of literature were included for review, and 11 active surveillance systems for vaccine safety were identified, mostly located in developed countries. These systems were constructed by 3 types of organizations: administration departments, academic or research institutions, and health care providers. Their data sources included immunization registries, electronic medical records, claims data, case reports of adverse events following immunization electronic questionnaires, and epidemiologic study data. According to their operation procedures, these systems were grouped into 4 modes of active surveillance: Data Linkage, Investigator Network, Automatic Follow-up System, Studies Consortium. Conclusion: Practice of active surveillance for vaccine safety greatly varies across countries, with different conditions and advantages. It is suggested that developing countries should choose suitable mode of active surveillance considering their local situations.
目的： 识别国外疫苗上市后安全性主动监测系统，全面了解其特点和机制。 方法： 按照基于文献的概括性评价研究步骤，检索文献数据库PubMed、Scopus和Cochrane Library中截至2018年6月30日发表的与疫苗安全主动监测系统相关的英文文献，并搜索相关网站的灰色文献，按照纳入排除标准对检出文献进行筛选，根据研究目的标绘纳入文献的有效信息，采用框架整合法和主题分析法对标绘信息进行整合。 结果： 共纳入97篇文献资料，从中识别出11个疫苗安全主动监测系统，主要来自发达国家。监测系统的组成机构包括行政管理部门、学术科研单位和医疗服务组织3类。监测数据来源包括免疫接种注册登记信息、电子医疗记录、医疗保险记录、预防接种不良反应事件（AEFI）病例报告、电子调查问卷和流行病学研究数据6类。根据运行机制的特点，监测系统可分为数据链接、监测员网络、自动随访系统和研究项目联盟4种主动监测模式。 结论： 全球疫苗安全主动监测的实践形式多样，具有不同的实施条件和优缺点，发展中国家需因地制宜，选择有效可行的监测模式。.
Keywords: Active surveillance; Adverse event following immunization; Scoping review; Vaccines.