CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
Pre-transfection F17 +3 morebiological
Likely dose
Pre-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/NCT00350337
NCT00350337Phase 2Completed
CompareCT.gov

Phase II, Randomized, Observer-Blind, Single Center, Controlled Study of Two Doses of Various Formulations of WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to Placebo Control Administered on 0-6-Month Schedule to Healthy Adults

U.S. Army Medical Research and Development Command·interventional·Posted Jul 10, 2006·Updated Feb 12, 2021

In Brief

A Phase 2 clinical trial evaluating Pre-transfection F17, Post-transfection F17, and 2 other interventions for Dengue. Completed, enrolled 86 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue
CountriesUnited States
CollaboratorsGlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 10, 2006
Enrollment StartApr 5, 2006
Primary CompletionJun 20, 2007
Study CompletionMar 13, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.0 years ago

Interventions

Pre-transfection F17biological

Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection

Post-transfection F17biological

Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.

Post-transfection F19biological

Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.

Placeboother

Sterile solution of buffered water (0.9% NaCl), U.S. FDA accepted vaccine excipient, phenol red dye(phenolsulfonphthalein, used in vaccines as a pH indicator); 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection