Created at Source Raw Value Validated value
April 8, 2022, 3:30 p.m. oms

Occurrence of adverse events (AEs) from the first injection to Day 28; in all participants; in all groups: o The occurrence of each solicited local and general AE; during each 7-day follow-up period after injection (e.g.; the day of injection and 6 subsequent days). o The occurrence of any unsolicited AEs for the entire study period. o The occurrence of any hematological (hemoglobin level; WBC; lymphocyte; neutrophil; eosinophil; and platelet count) and biochemical (ALT; AST; BUN; and Cr) clinically significant laboratory abnormality through to Day 28 and; o The occurrence of any serious AEs (SAEs) medically attended events (MAE); or adverse event of special interest (AESI) through to Day 365. • Occurrence of AEs from the second injection to Day 56 (28 days post injection); in all participants; in all groups: o The occurrence of solicited local and general AE; during each 7-day follow-up period after the second injection (e.g.; the day of 2nd injection and 6 subsequent days); o The occurrence of any unsolicited AEs for the entire study period and; o The occurrence of any hematological (hemoglobin level; WBC; lymphocyte; neutrophil; eosinophil; and platelet count) and biochemical (ALT; AST; BUN; and Cr) clinically significant laboratory abnormality through to Day 42

Occurrence of adverse events (AEs) from the first injection to Day 28; in all participants; in all groups: o The occurrence of each solicited local and general AE; during each 7-day follow-up period after injection (e.g.; the day of injection and 6 subsequent days). o The occurrence of any unsolicited AEs for the entire study period. o The occurrence of any hematological (hemoglobin level; WBC; lymphocyte; neutrophil; eosinophil; and platelet count) and biochemical (ALT; AST; BUN; and Cr) clinically significant laboratory abnormality through to Day 28 and; o The occurrence of any serious AEs (SAEs) medically attended events (MAE); or adverse event of special interest (AESI) through to Day 365. • Occurrence of AEs from the second injection to Day 56 (28 days post injection); in all participants; in all groups: o The occurrence of solicited local and general AE; during each 7-day follow-up period after the second injection (e.g.; the day of 2nd injection and 6 subsequent days); o The occurrence of any unsolicited AEs for the entire study period and; o The occurrence of any hematological (hemoglobin level; WBC; lymphocyte; neutrophil; eosinophil; and platelet count) and biochemical (ALT; AST; BUN; and Cr) clinically significant laboratory abnormality through to Day 42