drugset

drugset / Trial / NCT00350337

Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine in Healthy US Adults

NCT00350337 ↗

Phase 2 Completed 86 enrolled U.S. Army Medical Research and Development Command GlaxoSmithKline · collab Walter Reed Army Institute of Research (WRAIR) · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This descriptive study will evaluate the safety and immunogenicity of 3 different formulations of the WRAIR dengue vaccine compared to a placebo.

Timeline

Start: 2006-04-05
Primary completion: 2007-06-20
Completion: 2008-03-13

Publications

Thomas SJ, Eckels KH, Carletti I, De La Barrera R, Dessy F, Fernandez S, Putnak R, Toussaint JF, Sun W, Bauer K, Gibbons RV, Innis BL. A phase II, randomized, safety and immunogenicity study of a re-derived, live-attenuated dengue virus vaccine in healthy adults. Am J Trop Med Hyg. 2013 Jan;88(1):73-88. doi: 10.4269/ajtmh.2012.12-0361. Epub 2012 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Post-transfection F17	Vaccine	0.5 ml	Subcutaneous
Subject	Post-transfection F19	Vaccine	0.5 ml	Subcutaneous
Subject	Pre-transfection F17	Vaccine	0.5 ml	Subcutaneous

Indications