Statistical analysis
seroprotection/seropositivity
VIRUS, SECONDARY
The sample size of 300 participants per group (assuming approximately 15% drop-out) was sufficient to achieve approximately 90% overall power for demonstrating NI for the primary and secondary objectives. Sample size calculations assumed a one-sided significance level of 0.025 and were performed using nQuery AdvisorDENV and YF GMTs and seroprotection/seropositivity rates are presented as means with corresponding 95% CIs. Titers below 10 were given an arbitrary value 5. For the primary immunogenicity endpoint, NI was concluded if the upper bound of the 95% CI of the difference in YF seroprotection rates (Group 1 minus Group 3) at Month 1 was <5%. The Newcombe score method was used to compute the 95% CI of the rate difference [Data are presented for the per-protocol sets (PPS). The YF PPS, i.e. all randomized participants who received planned Day 1 study vaccination(s) and for whom a valid pre-dose (baseline) and at least one post-dose measurement (Day 30) were available for YF immunogenicity assessments, and who had no major protocol violations, excluding those who were seroprotected for YF virus and/or who were seropositive for any DENV serotype at baseline, was used for assessment of the primary endpoint. The PPS, i.e. all randomized participants who received all planned study vaccinations, who provided a valid baseline measurement and at least one post-vaccination measurement for immunogenicity assessments, and had no major protocol violations, excluding those who were seroprotected for YF virus and/or who were seropositive for any DENV serotype at baseline, was used for assessment of all other immunogenicity endpoints. Safety was analyzed descriptively for the safety set, i.e. all participants who were randomized and received at least one dose of any study vaccines. All statistical analysis was performed using SAS version 9.4.