目的 分析广东进行流感疫苗临床试验前流行病学关键点评价结果,为今后疫苗临床试验的可行性提供科学依据.方法 全面检索PubMed、CNKI、VIP、Wanfang Data等数据库,获取国内1998年3月至2016年8月公开发表的有关流感疫苗研究的文献,利用本单位及上级单位开展疫苗临床试验研究基础和总结资料,收集茂名市2013-2015年每周流感样病例就诊指数数据,采用描述性流行病学方法进行分析.结果 疫苗临床试验选择在茂名高州进行,重点考虑部分镇街.估计需要样本量为4162例,流感疫苗临床试验观察时间估计在2017年的3~7月.需要多种随访形式贯穿进行,以便获得最多的流感样病例.结论 流感疫苗在广东儿童人群进行研究前需要做好流行病学评价,保证疫苗临床试验工作的顺利开展.%Objective To analyze the preparation work before influenza vaccine conducted clinical trials in pe-diatric population in Guangdong, and to provide the scientific evidence of preparation work to vaccine clinical trials. Methods Literature related to influenza vaccine research published from March 1998 to August 2016 were got by re-trieving PubMed, CNKI, VIP, Wanfang Data. Using the clinical trials of vaccine research and summary of information of the unit and the higher units, the weekly influenza-like patient index data of Maoming City during 2013-2015 were col-lected and analyzed by descriptive epidemiological methods. Results The vaccine clinical trial was conducted with a sample of 4162 people in Gaozhou, Maoming especially in some towns. The observation time should be conductd from March to July in 2017. Follow-up should be carried out in various forms to obtain more influenza-like illness cases. Conclusion Pilot feasibility appraisal study should be done before influenza vaccine clinical trials in pediatric popula-tion in Guangdong, to ensure the smooth progress in clinical trial.
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