Statistics
ADVERSE EVENTS, REGRESSION, VIRAL SHEDDING
With 30 participants per IPV group, this study had an 80% probability of detecting at least one AE that occurs at a rate of 5.3% or higher. With 27 evaluable participants per IPV arm, this study was designed to provide at least 96% power to detect ≥60% reduction in shedding rate 8 days post-challenge in the IPV + dmLT group assuming the shedding rate in the IPV alone group was at least 80%. All adverse events were summarized for the total vaccinated population, according to treatment received. All participant-level percentages were supplemented with two-sided 95% confidence intervals (CIs) computed via the Clopper-Pearson method.The primary viral shedding endpoint was assessed in the per protocol population. The proportion of participants with stool positive for poliovirus was summarized by time point and group including corresponding 95% CIs. Proportions shedding in IPV groups were compared for each serotype and overall via one minus the relative risk and accompanied by a 95% CI computed using the Farrington and Manning method Immunogenicity assessments conducted in the per protocol population were summarized descriptively as GMTs, GMFRs, and seroresponse or seroconversion rates and compared between groups using baseline-adjusted GMT ratios. Geometric means were analyzed on the log scale, adjusted for baseline measures, and using survival regression analysis to accommodate censoring at LLOQ or ULOQ with antilog transformations of model-based estimates and corresponding 95% CIs.