CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
Dengue Vaccine Formulation 17 +1 morebiological
Likely dose
Dengue Vaccine Formulation 17 1 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/NCT00384670
NCT00384670Phase 2Completed
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A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children

U.S. Army Medical Research and Development Command·interventional·Posted Oct 6, 2006·Updated Feb 24, 2014

In Brief

A Phase 2 clinical trial evaluating Dengue Vaccine Formulation 17 and Licensed Japanese Encephalitis (JE) Vaccine for Dengue Fever. Completed, enrolled 7 participants across 1 site.

Detailed Summary

To assess the safety, reactogenicity and immunogenicity of two doses of the dengue vaccine in Flavi-virus antibody-naive children between 6 and 9 years of age.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2006
Enrollment StartAug 1, 2003
Primary CompletionMay 1, 2004
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.7 years ago

Interventions

Dengue Vaccine Formulation 17biological

Tetravalent live attenuated DEN vaccine candidate. Containing dengue serotypes 1,2, and 3 vaccines produced at the Salk Institute and dengue serotype 4 produced at the WRAIR Pilot Bioproduction Facility. Dosage 1 mL administered via injection at Day 0 and Day 60.

Licensed Japanese Encephalitis (JE) Vaccinebiological

Produced by the Thailand GPO using a Beijing strain of JE in liquid form; dosed at 0.5 mL ot 7 and 7.5 months.