Outcomes
death
ASYMPTOMATIC COVID-19, EVENTS, ADVERSE EVENTS
Consistent with other vaccine trials, the primary outcome was symptomatic COVID-19, confirmed by RT-PCR 14 days after the second and third doses. Secondary outcomes were severe COVID-19, COVID-19–related death, adverse events (AEs), and humoral and cellular immune responses (eMethods in Participants recorded solicited AEs (ie, set of symptoms or events that study participants are explicitly requested to document) using an online platform within 3 days after receiving each injection. Unsolicited AEs were followed up 28 days after each dose. Within 28 days after the injection of each dose, participants were followed up for any type of AEs (mildly or moderately severe, AEs with medically attended visits, or life-threatening AEs) on day 3 and then weekly through telephone calls. From day 28 until the end of the follow-up period, telephone follow-ups were performed every 2 weeks. Also, participants were supported with a continuously operating call center and medical visits. Medically attended AEs and serious AEs were monitored 6 months after the first dose in cohort 1 and 7 months after the first dose in cohort 2.