Created at Source Raw Value Validated value
May 27, 2021, 12:45 a.m. oms

1. Serious Adverse Events related to the vaccine-SAE (It will measure as: -Occurrence of the SAE (Yes; No); -Description of the AE (Name of the event); Duration (Time from start date until end date of event); Result (Recovered; Recovered with squeals; Persists; Death; Unknown); Causality (Causal association consistent with vaccination; Undetermined; Inconsistent causal association with vaccination; not classifiable)). Measurement time: daily for 28 days after dose. 2. Satisfactory Immune Response-SIR (Inhibitory titer 50 (IT50) = 250). Measurement time: Phase IIa: pre-vaccination and at 14 and 28 days post-vaccination. Phase IIb: pre-vaccination and 28 days post-vaccination.

1. Serious Adverse Events related to the vaccine-SAE (It will measure as: -Occurrence of the SAE (Yes; No); -Description of the AE (Name of the event); Duration (Time from start date until end date of event); Result (Recovered; Recovered with squeals; Persists; Death; Unknown); Causality (Causal association consistent with vaccination; Undetermined; Inconsistent causal association with vaccination; not classifiable)). Measurement time: daily for 28 days after dose. 2. Satisfactory Immune Response-SIR (Inhibitory titer 50 (IT50) = 250). Measurement time: Phase IIa: pre-vaccination and at 14 and 28 days post-vaccination. Phase IIb: pre-vaccination and 28 days post-vaccination.

April 23, 2021, 12:45 a.m. oms

1. Serious Adverse Events related to the vaccine-SAE (It will measure as: -Occurrence of the SAE (Yes; No); -Description of the AE (Name of the event); Duration (Time from start date until end date of event); Result (Recovered; Recovered with squeals; Persists; Death; Unknown); Causality (Causal association consistent with vaccination; Undetermined; Inconsistent causal association with vaccination; not classifiable)). Measurement time: daily for 28 days after dose. 2. Satisfactory Immune Response-SIR (Inhibitory titer 50 (IT50) >= 250). Measurement time: Phase IIa: pre-vaccination and at 14 and 28 days post-vaccination. Phase IIb: pre-vaccination and 28 days post-vaccination.

1. Serious Adverse Events related to the vaccine-SAE (It will measure as: -Occurrence of the SAE (Yes; No); -Description of the AE (Name of the event); Duration (Time from start date until end date of event); Result (Recovered; Recovered with squeals; Persists; Death; Unknown); Causality (Causal association consistent with vaccination; Undetermined; Inconsistent causal association with vaccination; not classifiable)). Measurement time: daily for 28 days after dose. 2. Satisfactory Immune Response-SIR (Inhibitory titer 50 (IT50) >= 250). Measurement time: Phase IIa: pre-vaccination and at 14 and 28 days post-vaccination. Phase IIb: pre-vaccination and 28 days post-vaccination.