NCT01073306 - 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)

Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS
Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. Review.
Durbin AP, McArthur JH, Marron JA, Blaney JE, Thumar B, Wanionek K, Murphy BR, Whitehead SS
rDEN2/4Delta30(ME), a live attenuated chimeric dengue serotype 2 vaccine is safe and highly immunogenic in healthy dengue-naïve adults. Hum Vaccin. 2006 Nov-Dec;2(6):255-60. Epub 2006 Nov 5.

A Phase I Evaluation of the Safety and Immunogenicity of rDEN2/4 Δ30(ME) Dengue Serotype 2 Vaccine Given at 10^1 PFU in Healthy Flavivirus-naïve Adult Subjects

Details for clinical trial NCT01073306

Clinical trial NCT01073306 - References