NCT01477580 - 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)

Manoff SB, George SL, Bett AJ, Yelmene ML, Dhanasekaran G, Eggemeyer L, Sausser ML, Dubey SA, Casimiro DR, Clements DE, Martyak T, Pai V, Parks DE, Coller BA
Preclinical and clinical development of a dengue recombinant subunit vaccine. Vaccine. 2015 Dec
Manoff SB, Sausser M, Russell AF, Martin J, Radley D, Hyatt D, Roberts CC, Lickliter J, Krishnarajah J, Bett A, Dubey S, Finn T, Coller BA, Stek J
Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-Naïve adults. Hum Vaccin Immunother. 2018 Nov 14. doi: 10.1080/21645515.2018.1546523. [Epub ahead of print]

A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine (V180) in Healthy Adults

Details for clinical trial NCT01477580

Clinical trial NCT01477580 - References