The outcome measurements for the Phase 1 and Phase 2 clinical trials of the BBV152 (Covaxin) vaccine evaluate patient safety and immune response across two distinct phases.

Primary Outcome Measurements:

• Phase 1: Occurrence of adverse events and serious adverse events (evaluating safety).
• Phase 2: Evaluation of neutralizing antibody titers pre- and post-vaccination (evaluating immune response).

Secondary Outcome Measurements:

• Phase 1: Evaluation of neutralizing antibody titers pre- and post-vaccination.
• Phase 2: Occurrence of adverse events and serious adverse events.