NCT05381350 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hu J, Liu Y, Liu S, Shu Q, Yang X, Chu K, Qiao Y, Hu Y, Wang K, Pan H
Safety and immunogenicity of a modified Omicron-adapted inactivated vaccine in healthy adults: a randomized, double-blind, active-controlled Phase III clinical trial. Front Immunol. 2023 Sep 18;14:1241153. doi: 10.3389/fimmu.2023.1241153. eCollection 2023.

A Randomized, Double-blind, Active-controlled Clinical Trial, as Well as an Immuno-bridging Clinical Trial by Parallel Testing Previous Serum After Primary Immunization, to Evaluate the Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above

Details for clinical trial NCT05381350

Clinical trial NCT05381350 - References