Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Phase 1: <br/ >1. The occurrence of immediate adverse events within two hours of vaccination 2. The occurrence of adverse events within 7 days of vaccination.3. The occurrence of any adverse events throughout the study duration 4. The occurrence of serious adverse events (SAEs) <br/ >Phase 2: <br/ >Primary <br/ >1. To evaluate the immunogenicity in terms of GMT and four-fold seroconversion <br/ >rate amongst the two selected BBV152 vaccine formulationsTimepoint: Phase 1: <br/ >Occurrence of Adverse events within 2hrs; at Day 7 and through out the study duration <br/ > <br/ >Phase 2: <br/ >Day 0; Day 14; Day 28; Day 42 Day 104 and Day 194 in two cohorts

Phase 1: <br/ >1. The occurrence of immediate adverse events within two hours of vaccination 2. The occurrence of adverse events within 7 days of vaccination.3. The occurrence of any adverse events throughout the study duration 4. The occurrence of serious adverse events (SAEs) <br/ >Phase 2: <br/ >Primary <br/ >1. To evaluate the immunogenicity in terms of GMT and four-fold seroconversion <br/ >rate amongst the two selected BBV152 vaccine formulationsTimepoint: Phase 1: <br/ >Occurrence of Adverse events within 2hrs; at Day 7 and through out the study duration <br/ > <br/ >Phase 2: <br/ >Day 0; Day 14; Day 28; Day 42 Day 104 and Day 194 in two cohorts

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

July 30, 2021, 1:30 p.m. oms

Phase 1: <br/ >1. The occurrence of immediate adverse events within two hours of vaccination 2. The occurrence of adverse events within 7 days of vaccination.3. The occurrence of any adverse events throughout the study duration 4. The occurrence of serious adverse events (SAEs) <br/ >Phase 2: <br/ >Primary <br/ >1. To evaluate the immunogenicity in terms of GMT and four-fold seroconversion <br/ >rate amongst the two selected BBV152 vaccine formulationsTimepoint: Phase 1: <br/ >Occurrence of Adverse events within 2hrs; at Day 7 and through out the study duration <br/ > <br/ >Phase 2: <br/ >Day 0; Day 14; Day 28; Day 42 Day 104 and Day 194 in two cohorts

Phase 1: <br/ >1. The occurrence of immediate adverse events within two hours of vaccination 2. The occurrence of adverse events within 7 days of vaccination.3. The occurrence of any adverse events throughout the study duration 4. The occurrence of serious adverse events (SAEs) <br/ >Phase 2: <br/ >Primary <br/ >1. To evaluate the immunogenicity in terms of GMT and four-fold seroconversion <br/ >rate amongst the two selected BBV152 vaccine formulationsTimepoint: Phase 1: <br/ >Occurrence of Adverse events within 2hrs; at Day 7 and through out the study duration <br/ > <br/ >Phase 2: <br/ >Day 0; Day 14; Day 28; Day 42 Day 104 and Day 194 in two cohorts