NCT03311659 - 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)

Asatryan A, Meyer N, Scherbakov M, Romanenko V, Osipova I, Galustyan A, Shamsheva O, Latysheva T, Myasnikova T, Baudson N, Dodet M, Xavier S, Harrington L, Kuznetsova A, Campora L, Van den Steen P
Immunogenicity, safety, and reactogenicity of combined reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine administered as a booster vaccine dose in healthy Russian participants: a phase III, open-label study. Hum Vaccin Immunother. 2020 Aug 26:1-8. doi: 10.1080/21645515.2020.1796423. [Epub ahead of print]

Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' dTpa Booster Vaccine (263855) (Boostrix) Administered as a Booster Dose in Healthy Russian Subjects

Details for clinical trial NCT03311659

Clinical trial NCT03311659 - References