GlaxoSmithKline Vaccines, Rue de l' Institut 89, 1330 Rixensart, Belgium.
Expert Rev Clin Pharmacol. 2013 Jul;6(4):403-11. doi: 10.1586/17512433.2013.811817.
The efficacy assessment of an influenza vaccine often requires conducting large and expensive clinical trials. Specificities of influenza increase the complexity of the study designs, of the subsequent statistical analysis and of the interpretation of the results. They include low attack rates, seasonality, multiplicity and frequent mutations of flu viruses as well as heterogeneity of virus circulation, varying annual vaccine composition and so on. The authors discuss how those factors may impact the design, the conduct and the analysis of an efficacy trial and explain why it may fail whatever the true vaccine efficacy. The authors then argue that extending the length to several consecutive seasons is an alternative to the frequently used 1-year design and propose refinements of the statistical models.
流感疫苗的疗效评估通常需要进行大规模和昂贵的临床试验。流感的特殊性增加了研究设计、后续统计分析和结果解释的复杂性。这些特殊性包括低发病率、季节性、流感病毒的多发性和频繁突变以及病毒传播的异质性、每年疫苗成分的变化等。作者讨论了这些因素如何影响疗效试验的设计、实施和分析，并解释了为什么无论真实疫苗的疗效如何，它都可能失败。作者随后认为，将时间延长至连续几个季节是对常用的 1 年设计的替代方案，并提出了对统计模型的改进。
