流感疫苗临床保护效力研究设计的一般考虑

General considerations for the design of study on clinical protective efficacy of influenza vaccine

本文结合国内外流感疫苗研发实践和国外监管机构要求,综合考虑流感疫苗特点及我国疫苗临床研究现状,参考相关指导原则和技术考虑,探讨了流感疫苗保护效力研究的临床试验设计中重点考虑的问题,包括有效性终点判定、流感实验室诊断方法、临床主要终点和诊断流程、适应性设计及期中分析、受试者选择和样本量、试验现场和对照的合理选择、安全性的特殊考虑和上市后研究等。为开展流感疫苗保护效力研究时提供借鉴和参考。

This article combines development practice in China and abroad,and international regulatory requirements of influenza vaccine,comprehensively considers characteristics of influenza vaccines and its clinical research status in our country,refers to related guidelines and technical considerations,and discusses the key considerations in the design of protective efficacy clinical trials,including efficacy end point determination,influenza laboratory diagnosis,primary end points and diagnostic process,the adaptive design and interim analysis,choice of subjects and sample size,clinical trial site and rational reference substance,special considerations for security,as well as post-marketing studies.This article can provide reference for influenza vaccine clinical trials.