Outcomes
The primary outcome measure was the reactogenicity and safety profile of 1/10 and 1/5 doses of Sputnik V, including the number of participants with SAE’s and AE’s monitored throughout the study, the quantity and intensity of solicited local and systemic AE’s after vaccination. Secondary outcome measures were geometric mean titres (GMT) of antigen-specific IgGs measured by ELISA as well as the percentage of seroconverted participants on day 1 (before vaccination) and days 42 and 180.