Vaccine candidates must go through a series of clinical trials in order to be proved efficacious and safe for licensure. Each clinical trial phase has been clearly defined by our project management team:
First-in-Human Clinical Trials:
First-in-human studies are small studies in healthy adults - usually 20-80 subjects - to evaluate the safety and immunogenicity of a vaccine candidate.
Phase I Clinical Trials:
Phase I clinical trials are small safety studies in different target populations. These may include a preliminary assessment of dose-range and/or age de-escalation.
Phase IIa Clinical Trials:
Phase IIa clinical trials are larger studies - usually 100-300 subjects - that explore dose-range in target populations with the goal of identifying the optimum dose; the dosing schedule; and/or the route of administration based on safety, immunogenicity and/or biological endpoints. These are focused studies designed to provide evidence of biological activity in the target population.
Phase IIb Clinical Trials:
Phase IIb clinical trials are larger, well-controlled studies that evaluate safety and proof-of-concept/efficacy. These trials usually include more than 1,000 subjects and are designed to demonstrate evidence of disease prevention or treatment in the target population.
Phase III Clinical Trials:
Phase III clinical trials are pivotal registration studies to support licensure. They are designed to demonstrate statistically significant evidence of disease prevention or treatment and long-term safety in target populations as required by national regulatory authorities. These studies are conducted with the final manufactured product.