Statistical analysis
ADVERSE EVENT
The statistical analysis was conducted using SASThe database was locked and unblinded five weeks after the last participant received their last dose. The data presented here are up to 6 months (day 180) for anti-RBD and anti-S IgG antibody levels by MSD and up to day 42 for all other safety and immunogenicity analyses, two weeks after the last participant received their last dose.Immunogenicity data were summarized by cohort and time point using descriptive statistics along with geometric mean and 95% CI. Results were analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect for each visit. Placebo participants were pooled for comparison. ANOVA with Tukey’s multiple comparison was performed (F [3, 55] = 26.90, degrees of freedom = 3). Analysis was performed at a 5% level of significance. The correlation coefficients were calculated using a two-tail Pearson correlation with 95% confidence.The number and percentage of participants reporting any treatment-emergent adverse event or reactogenicity were summarized by cohort and tabulated by system organ class and preferred term (coded using MedDRA, WHO Global B3 format—MAR 2021).