Statistical analysis
SAEs
All participants who receive the single dose of vaccine will be analyzed for safety and immunogenicity. SAEs and AEs will be tabulated by grade and proportions of people with each AE. Comparisons of the SAEs and AEs among groups will be performed using Fisher’s exact for the overall test and Fisher’s exact unconditional tests and tests of proportions for two group comparisons (using R with fisher.test or uncondExact2 × 2 in exact2 × 2 library). All immunologic data will be analyzed using a log