A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children

Phase 2 Completed 636 enrolled U.S. Army Medical Research and Development Command GlaxoSmithKline · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to evaluate the safety and effectiveness of two different formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two doses are given six months apart to adults and children.

Timeline

Start: 2007-07
Primary completion: 2010-04
Completion: 2010-04

Publications

Bauer K, Esquilin IO, Cornier AS, Thomas SJ, Quintero Del Rio AI, Bertran-Pasarell J, Morales Ramirez JO, Diaz C, Carlo S, Eckels KH, Tournay E, Toussaint JF, De La Barrera R, Fernandez S, Lyons A, Sun W, Innis BL. A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico. Am J Trop Med Hyg. 2015 Sep;93(3):441-453. doi: 10.4269/ajtmh.14-0625. Epub 2015 Jul 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	T-DEN-Post-Transfection F17	Vaccine	0.5 ml	Other
Subject	T-DEN-Post-Transfection F19	Vaccine	0.5 ml	Other

A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children

Summary

Timeline

Publications

Drugs

Indications