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. <br/ >2. The occurrence of adverse events within seven days . <br/ >3. The occurrence of any adverse events throughout the study duration <br/ > 4. The occurrence of serious adverse events (SAEs). <br/ > <br/ >Phase 2 <br/ >1. To evaluate the immunogenicity in terms of four-fold seroconversion rate of SARSCoV- <br/ >2 virus neutralizing antibodies across the two dosage strengths of BBV152D.Timepoint: Phase 1 <br/ > <br/ >1.Time Frame: 2 hours. <br/ >2.Time Frame: 7 <br/ >days <br/ >3. Time Frame: throughout the study duration <br/ >4.Time Frame: throughout the <br/ >study duration. <br/ > <br/ >Phase 2 <br/ >baseline to day 0; 14; 28; 42; 104 and 194.

Phase 1 <br/ >1. The occurrence of immediate adverse events within two hours of vaccination. <br/ >2. The occurrence of adverse events within seven days . <br/ >3. The occurrence of any adverse events throughout the study duration <br/ > 4. The occurrence of serious adverse events (SAEs). <br/ > <br/ >Phase 2 <br/ >1. To evaluate the immunogenicity in terms of four-fold seroconversion rate of SARSCoV- <br/ >2 virus neutralizing antibodies across the two dosage strengths of BBV152D.Timepoint: Phase 1 <br/ > <br/ >1.Time Frame: 2 hours. <br/ >2.Time Frame: 7 <br/ >days <br/ >3. Time Frame: throughout the study duration <br/ >4.Time Frame: throughout the <br/ >study duration. <br/ > <br/ >Phase 2 <br/ >baseline to day 0; 14; 28; 42; 104 and 194.

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

N/A

N/A

Dec. 16, 2020, 10:47 a.m. oms

Phase 1 <br/ >1. The occurrence of immediate adverse events within two hours of vaccination. <br/ >2. The occurrence of adverse events within seven days . <br/ >3. The occurrence of any adverse events throughout the study duration <br/ > 4. The occurrence of serious adverse events (SAEs). <br/ > <br/ >Phase 2 <br/ >1. To evaluate the immunogenicity in terms of four-fold seroconversion rate of SARSCoV- <br/ >2 virus neutralizing antibodies across the two dosage strengths of BBV152D.Timepoint: Phase 1 <br/ > <br/ >1.Time Frame: 2 hours. <br/ >2.Time Frame: 7 <br/ >days <br/ >3. Time Frame: throughout the study duration <br/ >4.Time Frame: throughout the <br/ >study duration. <br/ > <br/ >Phase 2 <br/ >baseline to day 0; 14; 28; 42; 104 and 194.

Phase 1 <br/ >1. The occurrence of immediate adverse events within two hours of vaccination. <br/ >2. The occurrence of adverse events within seven days . <br/ >3. The occurrence of any adverse events throughout the study duration <br/ > 4. The occurrence of serious adverse events (SAEs). <br/ > <br/ >Phase 2 <br/ >1. To evaluate the immunogenicity in terms of four-fold seroconversion rate of SARSCoV- <br/ >2 virus neutralizing antibodies across the two dosage strengths of BBV152D.Timepoint: Phase 1 <br/ > <br/ >1.Time Frame: 2 hours. <br/ >2.Time Frame: 7 <br/ >days <br/ >3. Time Frame: throughout the study duration <br/ >4.Time Frame: throughout the <br/ >study duration. <br/ > <br/ >Phase 2 <br/ >baseline to day 0; 14; 28; 42; 104 and 194.