CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
T-DEN F17 +2 morebiological
Likely dose
T-DEN F17 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00370682
NCT00370682Phase 2Completed
CompareCT.gov

Phase II, Randomized, Double-blind, Single Center, Controlled Study of Two Doses of Different Formulations of the WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to a Placebo Control, Administered on a 0-6 Month Schedule, to Healthy Adults

U.S. Army Medical Research and Development Command·interventional·Posted Sep 1, 2006·Updated May 30, 2017

In Brief

A Phase 2 clinical trial evaluating T-DEN F17, T-DEN F-19, and 1 other intervention for Dengue. Completed, enrolled 120 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue
CountriesThailand
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2006
Enrollment StartApr 1, 2007
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.8 years ago

Interventions

T-DEN F17biological

A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

T-DEN F-19biological

A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Placebo Comparatorother

A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.