drugset

drugset / Trial / NCT00384670

A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children

NCT00384670 ↗

Phase 1/2 Completed 7 enrolled U.S. Army Medical Research and Development Command GlaxoSmithKline · collab

NaSingle-groupOpen-labelPrevention

Summary

To assess the safety, reactogenicity and immunogenicity of two doses of the dengue vaccine in Flavi-virus antibody-naive children between 6 and 9 years of age.

Timeline

Start: 2003-08
Primary completion: 2004-05
Completion: 2004-05

Publications

Simasathien S, Thomas SJ, Watanaveeradej V, Nisalak A, Barberousse C, Innis BL, Sun W, Putnak JR, Eckels KH, Hutagalung Y, Gibbons RV, Zhang C, De La Barrera R, Jarman RG, Chawachalasai W, Mammen MP Jr. Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in flavivirus naive children. Am J Trop Med Hyg. 2008 Mar;78(3):426-33.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dengue Vaccine Formulation 17	Vaccine	1 ml	Subcutaneous
Background	Licensed Japanese Encephalitis (JE) Vaccine	Vaccine	0.5 ml	Subcutaneous

Indications