NCT01086657 - 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)

Luke CJ, Subbarao K
Vaccines for pandemic influenza. Emerg Infect Dis. 2006 Jan;12(1):66-72. Review.
Subbarao K, Murphy BR, Fauci AS
Development of effective vaccines against pandemic influenza. Immunity. 2006 Jan;24(1):5-9.
Taubenberger JK, Reid AH, Lourens RM, Wang R, Jin G, Fanning TG
Characterization of the 1918 influenza virus polymerase genes. Nature. 2005 Oct 6;437(7060):889-93.

VRC 310: An Open-Label, Randomized Ph I: Healthy Adults of Prime-Boost Intervals w/Monovalent Influenza Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc), Administered Alone or Following Recombinant H5 DNA Vaccine

Details for clinical trial NCT01086657

Clinical trial NCT01086657 - References