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Phase II
- Inclusion of a larger volunteer cohort, investigation of adverse effects, efficacy, and dose refinement.
- The primary objective of this phase is to evaluate the protective value of the vaccine candidates across a larger group of healthy volunteers compared to Phase 1. This stage investigates effective threshold values, clinical efficacy, biological activity, and therapeutic benefits.
- The vaccine candidate is compared against a placebo or a standard vaccine (active comparator).
- This phase focuses on characterizing the safety and side-effect profile of the vaccine and gathering comprehensive dose-response data.
- Studies are typically conducted with 100 to 300 volunteers.