Statistical analysis
ADVERSE EVENTS, EVENTS
The study was designed with a 90% power to detect the primary endpoint of non-inferiority in seroconversion of the fractional dose compared with the standard dose of the 17D-213 YF vaccine 28 days after vaccination. On the basis of previous data,There were three populations defined for analysis. The primary per-protocol population was defined as participants who gave a blood sample at baseline and at 28 (±3) days after vaccination, who were seronegative (PRNTThe number and percentage of participants who seroconverted, with their two-sided exact Clopper-Pearson 95% CIs, were summarised by dose. To assess non-inferiority for the primary outcome, we constructed a two-sided 95% CI around the point estimate of the difference between seroconversion rates in the fractional and standard dose groups using the Wilson score interval. Non-inferiority of the fractional dose was then concluded if the lower bound of the CI for the difference in seroconversion was greater than –17%.Two-sided 95% CIs of the mean difference between the natural logarithm of GMT between the standard and fractional dose arms were produced using the The immunogenicity outcomes were assessed in the per-protocol and ITT populations. These analyses were repeated for 10 days and 365 days after vaccination (long term). Long-term assessment was done separately for individuals who were assessed within the planned study timelines (ie, 365 ±14 days) and those assessed outside of the study timelines (ie, >365 + 14 days).Adverse events and serious adverse events were summarised as number and percentage by dose group. Safety outcomes were assessed in all vaccinated participants.Analyses were performed using Stata version 15.0. Figures were produced in R version 3.6.2 and GraphPad Prism version 9.4.0.This study is registered with 