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

1. Occurrence and severity of local reactogenicity AEs for 7 days following each dose of vaccination. <br/ >2. Occurrence; severity and relationship of systemic reactogenicity AEs for 7 days following each dose of vaccination. <br/ >3. Occurrence; severity and relationship of unsolicited AEs up to 28 days following each dose of vaccination. <br/ >4. Occurrence of SAE at any time during study participation. <br/ >5. Changes in safety assessments including laboratory parameters and vital signs from baseline.Timepoint: Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.

1. Occurrence and severity of local reactogenicity AEs for 7 days following each dose of vaccination. <br/ >2. Occurrence; severity and relationship of systemic reactogenicity AEs for 7 days following each dose of vaccination. <br/ >3. Occurrence; severity and relationship of unsolicited AEs up to 28 days following each dose of vaccination. <br/ >4. Occurrence of SAE at any time during study participation. <br/ >5. Changes in safety assessments including laboratory parameters and vital signs from baseline.Timepoint: Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.

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

N/A

N/A

May 27, 2021, 12:45 a.m. oms

1. Occurrence and severity of local reactogenicity AEs for 7 days following each dose of vaccination. <br/ >2. Occurrence; severity and relationship of systemic reactogenicity AEs for 7 days following each dose of vaccination. <br/ >3. Occurrence; severity and relationship of unsolicited AEs up to 28 days following each dose of vaccination. <br/ >4. Occurrence of SAE at any time during study participation. <br/ >5. Changes in safety assessments including laboratory parameters and vital signs from baseline.Timepoint: Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.

1. Occurrence and severity of local reactogenicity AEs for 7 days following each dose of vaccination. <br/ >2. Occurrence; severity and relationship of systemic reactogenicity AEs for 7 days following each dose of vaccination. <br/ >3. Occurrence; severity and relationship of unsolicited AEs up to 28 days following each dose of vaccination. <br/ >4. Occurrence of SAE at any time during study participation. <br/ >5. Changes in safety assessments including laboratory parameters and vital signs from baseline.Timepoint: Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.