Statistical analysis
infectious disease
EVENTS, DISEASE, INFECTIOUS DISEASE
We needed 365 events of the primary outcome to demonstrate the non-inferiority of Fakhravac based on a 10% non-inferiority margin of the reported 72.8% efficacy of BBIBP-Corv-2 [We used frequencies (percentages) for categorical variables and mean (SD) for continuous variables to compare baseline values in the study groups and report adverse events/reactions. All those who received the standard first dose made the safety and the intention-to-treat (ITT) efficacy populations. The ITT population was used for sensitivity analysis. The modified ITT efficacy population included participants who received both vaccine doses.We used Kaplan Meier survival analysis and log-rank test to compare the occurrence of the outcomes in the study groups. Cox proportional hazard modeling was used to estimate hazard ratios and their 95% confidence intervals. Model assumptions were checked using proportional hazard graphs, Schoenfeld residuals against time plots, and formal proportional hazard tests. We used the Stata 11 and R 4.3.2 software.An eight-member data and safety monitoring board (DSMB) oversaw the conduct of the study and received periodic safety reports. The DSMB consisted of one person from each of the following specialties: clinical pharmacotherapist, epidemiologist, cardiologist, infectious disease specialist, oncologist, and representatives from the regularity authorities (FDO), the National Ethics Committee, and the Ministry of Health’s Center for Disease Control.This study was registered with the Iranian Registry of Clinical Trials (