Clinical safety and immunogenicity data in vaccines are commonly dichotomized into responder and nonresponder binary data. This article expands upon Fagerland, Lyndersen, and Laake to further study Newcombe’s hybrid score and Fisher’s conditional exact test using imbalanced randomization in vaccine clinical studies. The intent of this article is to study a potential statistical issue in clinical study design and analysis; hence, no reference to any particular product is made.

中文翻译：

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疫苗临床安全性试验中的随机分配失衡

疫苗中的临床安全性和免疫原性数据通常分为响应者和非响应者二进制数据。本文在Fagerland，Lyndersen和Laake的基础上进行了扩展，以进一步在疫苗临床研究中使用不平衡随机化来进一步研究Newcombe的杂交评分和Fisher的条件精确检验。本文的目的是研究临床研究设计和分析中的潜在统计问题。因此，未提及任何特定产品。