NCT02914184 - 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)

Salamanca de la Cueva I, Pahud B, Huang LM, Leonardi M, Garcia-Sicilia J, Céspedes J, Abdelnour A, Tamura T, Kuroki H, Chiu NC, Virta M, Kokko S, Horn M, Panzer F, Kim JH, Jin L, Moerman L, Debacq C, Parra J, Ugarte A, Bi D; Rota-081 Study Group
Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial. J Infect Dis. 2020 May 4. pii: jiaa210. doi: 10.1093/infdis/jiaa210. [Epub ahead of print]

Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Details for clinical trial NCT02914184

Clinical trial NCT02914184 - References