Statistical methods
EVENTS, EVENT, EVENT
Safety data were summarized for the safety population consisting of all enrolled participants who received at least one dose of study product (Any medical condition that was present at the time that the participant was screened was considered baseline and not reported as an AE, unless it worsened in severity or increased in frequency during the study. When calculating the incidence of AEs (The proportion of participants reporting at least 1 solicited AE was summarized by event, vaccine group, and maximum severity, along with the 95% Wilson score confidence interval (CI) for the proportion. Event rates were compared between each vaccine group and the pooled comparator vaccine group using Fisher’s Exact Test. The proportion of participants reporting at least 1 unsolicited AE was summarized by vaccine group for each vaccination and across all vaccinations. Clinical laboratory events were summarized by severity, time point, and vaccine group.