Created at Source Raw Value Validated value
Oct. 7, 2021, 9:30 a.m. oms

Phase I: 1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes; No); - Duration (Time from start date until end date of event); -Description of the 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: 28 days after dose. Phase II1) Molecular inhibition titer (mVNT50). Measurement time: At baseline and; 14 or 28 days (random distribution of the study sample between the two times).

Phase I: 1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes; No); - Duration (Time from start date until end date of event); -Description of the 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: 28 days after dose. Phase II1) Molecular inhibition titer (mVNT50). Measurement time: At baseline and; 14 or 28 days (random distribution of the study sample between the two times).