Imbalanced Randomization in Vaccine Clinical Safety Trials

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.</p

Additional file 1: of Some extensions in continuous models for immunological correlates of protection

Detail of methods and results for non-symmetrical protection curve models. (DOCX 116 kb

Additional file 6: of Some extensions in continuous models for immunological correlates of protection

Detail of results for estimation of standard errors. (DOCX 59 kb

Additional file 2: of Some extensions in continuous models for immunological correlates of protection

Detail for limiting the steepness of the protection curve, maximum likelihood estimates, evaluation criteria and fitting and calculation notes. (DOCX 47 kb

Additional file 3: of Some extensions in continuous models for immunological correlates of protection

Illustrative SAS code to create the datasets reconstructed from published sources and fit models. (DOCX 50 kb