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

1 Occurrence of immediate adverse events within two hours of vaccination <br/ >2 Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events within 28 days after vaccination. <br/ >3 Occurrence of Serious Adverse Events throughout the study duration. <br/ >4 Occurrence of Adverse Events of Special Interest (AESI) throughout the study duration <br/ >5 To evaluate the GMTs and seroconversion of COVAXIN®Timepoint: Day 28±2; 56±7; 118±7 and 208±7

1 Occurrence of immediate adverse events within two hours of vaccination <br/ >2 Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events within 28 days after vaccination. <br/ >3 Occurrence of Serious Adverse Events throughout the study duration. <br/ >4 Occurrence of Adverse Events of Special Interest (AESI) throughout the study duration <br/ >5 To evaluate the GMTs and seroconversion of COVAXIN®Timepoint: Day 28±2; 56±7; 118±7 and 208±7

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

N/A

N/A

Sept. 8, 2021, 1:30 a.m. oms

1 Occurrence of immediate adverse events within two hours of vaccination <br/ >2 Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events within 28 days after vaccination. <br/ >3 Occurrence of Serious Adverse Events throughout the study duration. <br/ >4 Occurrence of Adverse Events of Special Interest (AESI) throughout the study duration <br/ >5 To evaluate the GMTs and seroconversion of COVAXIN®Timepoint: Day 28±2; 56±7; 118±7 and 208±7

1 Occurrence of immediate adverse events within two hours of vaccination <br/ >2 Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events within 28 days after vaccination. <br/ >3 Occurrence of Serious Adverse Events throughout the study duration. <br/ >4 Occurrence of Adverse Events of Special Interest (AESI) throughout the study duration <br/ >5 To evaluate the GMTs and seroconversion of COVAXIN®Timepoint: Day 28±2; 56±7; 118±7 and 208±7