关于季节性流感灭活疫苗临床试验技术评价的考虑

Considerations of technical evaluation and clinical trials for seasonal inactivated influenza vaccines

本文主要基于国内季节性流感灭活疫苗的上市注册申请和技术审评,分析和总结了此类流感疫苗在临床试验设计中应重点考虑的问题,及其安全性和有效性评价时须关注的要点,即在目标人群、对照选择、评价标准及相关统计学考虑等方面提出建议,供相关研究人员在设计季节性流感灭活疫苗进行临床试验时借鉴和参考。

Based on the registration applications and technical review of Chinese seasonal inactivated influenza vaccines,this article analyzed and summarized the key points to be considered in the design of clinical trials as well as in the evaluation of safety and efficacy of the vaccines. Suggestions were provided on target population,selection of control,criteria of assessment and related statistical methods in design of clinical trials,which can be references for researchers of vaccine development.