Immuno-bridging and Broadening Study of a Whole, Inactivated COVID-19 Vaccine BBV152 in Healthy Adults

Participants in stable health will be randomly assigned into one of four groups based on their age to receive either 6 µg of BBV152 or placebo in a 1:1 ratio. Each participant will receive 2 doses of the study vaccine by 0.5 mL intramuscular injection, the first on Day 0 and the second on Day 28. Data will be collected in an observer-blind manner. Safety will be monitored by the Data and Safety Monitoring Board. The Data and Safety Monitoring Board will convene to perform safety reviews at 2 and 6 months and for immediate concerns regarding safety observations as needed. Safety assessment will include monitoring solicited, unsolicited, serious, medically attended adverse events and potentially immune medicated medical conditions. Since this is a bridging study, the maximum sample size of the data from the previous study will be 31 samples from the \<65 years population and 358 with samples from the 18 to \<65 years population.