CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 636 enrolled
Drug / intervention
T-DEN-Post-Transfection F17 +2 morebiological
Likely dose
T-DEN-Post-Transfection 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/NCT00468858
NCT00468858Phase 2Completed
CompareCT.gov

Phase II, Randomized, Double-blind, Placebo-controlled Study of Two Doses of WRAIR Live Attenuated Tetravalent Dengue Vaccine Formulations, Administered Six Months Apart, to Healthy Adults and Children

U.S. Army Medical Research and Development Command·interventional·Posted May 3, 2007·Updated Jul 2, 2017

In Brief

A Phase 2 clinical trial evaluating Placebo, T-DEN-Post-Transfection F17, and 1 other intervention for Dengue Fever and 2 related conditions. Completed, enrolled 636 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Fever, Dengue Hemorrhagic Fever, Dengue Shock Syndrome
CountriesPuerto Rico
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 3, 2007
Enrollment StartJul 1, 2007
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.2 years ago

Interventions

Placeboother

Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

T-DEN-Post-Transfection F17biological

Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

T-DEN-Post-Transfection F19biological

Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months