drugset

drugset / Trial / NCT01666652

A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults

NCT01666652 ↗

Phase 1 Completed 100 enrolled U.S. Army Medical Research and Development Command GlaxoSmithKline · collab Walter Reed Army Institute of Research (WRAIR) · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.

Timeline

Start: 2012-09
Primary completion: 2015-09
Completion: 2017-11

Publications

Schmidt AC, Lin L, Martinez LJ, Ruck RC, Eckels KH, Collard A, De La Barrera R, Paolino KM, Toussaint JF, Lepine E, Innis BL, Jarman RG, Thomas SJ. Phase 1 Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults in the United States. Am J Trop Med Hyg. 2017 Jun;96(6):1325-1337. doi: 10.4269/ajtmh.16-0634.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TDENV-PIV	Vaccine	1 ug	Intramuscular
Subject	TDENV-PIV	Vaccine	4 ug	Intramuscular

Indications