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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Pub Med、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4 162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 epidemiological results of key points before the clinical trial of influenza vaccine in Guangdong and provide a scientific basis for the feasibility of future clinical trials of vaccines. Methods The databases of Pub Med, CNKI, VIP and Wanfang Data were searched comprehensively to obtain the literature on influenza vaccine research published in China from March 1998 to August 2016. The basis and summary of vaccine clinical trial research by this unit and its higher authorities Data were collected to collect data on weekly flu-like illness referral index in Maoming from 2013 to 2015 and analyzed by descriptive epidemiological method. Results The clinical trials of vaccines were conducted in Gaozhou, Maoming, with emphasis on some townships. The estimated sample size required is 4 162 cases. The clinical trial duration of influenza vaccine is estimated from March to July 2017. Various forms of follow-up are required throughout to get the most flu-like cases. Conclusions Influenza vaccine needs to be epidemiologically evaluated before the study on children in Guangdong and to ensure the successful development of vaccine clinical trials.