Created at Source Raw Value Validated value
Nov. 12, 2021, 5:03 p.m. oms

Phase II: <br/ >1. Occurrence of any adverse reactions. <br/ >2.The occurrence of solicited symptoms and their severity. <br/ >3. The occurrence of any unsolicited adverse events and their severity. <br/ >4. The occurrence and severity of any SAEs or medically attended AEs or AEs of special interest (AESIs). <br/ > <br/ >Phase III: <br/ >1. Immune response in terms of geometric mean neutralizing titres and their geometric mean fold riseTimepoint: Phase II: <br/ >1. Within 60 minutes of immediate post vaccination period after each dose. <br/ >2. 7 consecutive days after each dose. <br/ >3.Till 28 days after each post vaccination period. <br/ >4. 28 days after each dose. <br/ > <br/ >Phase III: <br/ >1. from baseline; at day 42.

Phase II: <br/ >1. Occurrence of any adverse reactions. <br/ >2.The occurrence of solicited symptoms and their severity. <br/ >3. The occurrence of any unsolicited adverse events and their severity. <br/ >4. The occurrence and severity of any SAEs or medically attended AEs or AEs of special interest (AESIs). <br/ > <br/ >Phase III: <br/ >1. Immune response in terms of geometric mean neutralizing titres and their geometric mean fold riseTimepoint: Phase II: <br/ >1. Within 60 minutes of immediate post vaccination period after each dose. <br/ >2. 7 consecutive days after each dose. <br/ >3.Till 28 days after each post vaccination period. <br/ >4. 28 days after each dose. <br/ > <br/ >Phase III: <br/ >1. from baseline; at day 42.