含组分百日咳联合疫苗境内临床试验现况分析

Analysis of the current clinical trials of the combined vaccines containing componential pertussis in China

本文梳理了境内外含组分百日咳联合疫苗的上市和使用现况,对境内已完成和正在进行的注册临床试验进行了汇总,重点分析了此类品种境内临床试验设计的特点和组织实施的难点,为同类品种后续开展临床试验和技术评价提供参考。

This article reviews the current marketing and usage status of the combined vaccines containing componential pertussis both domestically and foreign.We also summarizes the registered clinical trials that have been completed and ongoing in China.The characteristics of domestic clinical trial design and the difficulties in clinical research and development of the combined vaccines are analyzed further,providing references for subsequent clinical trails and technical evaluation of similar vaccines.