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Phase III
Large-scale volunteer groups, detection of rare adverse effects, and comprehensive efficacy and safety evaluations.
- This is the phase of comparative studies conducted against a placebo or a standard vaccine control, aimed at determining the vaccine's protective efficacy and monitoring its side-effect profile.
- The "Approval" process for the product's use as a vaccine begins only after Phase 3 data provides sufficient evidence of efficacy and demonstrates that adverse effects are either non-existent or exceptionally mild and infrequent.
- Data for this phase is derived from both controlled and uncontrolled studies. The objective is to evaluate the clinical efficacy and safety of the vaccine within a broader and more diverse volunteer population.