疫苗双盲临床试验中备用苗的配备方法探讨及比较

Preparation and comparison of concealment allocation methods of alternative vaccine in double-blinded clinical vaccine trials

注射剂型的疫苗运输保存中的破损会影响临床试验的接种程序,需要配备一定比例备用苗,恰当的配备数量和方式对于确保双盲临床试验隐蔽分组和盲法的有效性以及控制试验成本的经济性十分重要。本文提出了2种备用苗配备的新方法并与传统方法进行综合比较,为疫苗双盲临床试验中备用苗的配备方法的选择提供依据。

The breakage of injectable vaccine during transport and storage would affect the whole injection proceed in clinical trials, so an allocation of a certain proportion with alternative vaccine is necessary. It is important to determine an appropriate number and method of alternative vaccine to assume the economic efficiency and blinding effectiveness. In this article, two new allocation concealment methods for alternative vaccine in clinical trials were proposed and comprehensively compared for providing the basis for alternative vaccine allocation concealment in double-blinded vaccine trials.