CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 192 enrolled
Drug / intervention
TV005 vaccine +1 morebiological
Likely dose
Not stated in 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/NCT02678455
NCT02678455Phase 2Completed

Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixture TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 9, 2016·Updated Jan 17, 2025

In Brief

A Phase 2 clinical trial evaluating TV005 vaccine and Placebo for Dengue. Completed, enrolled 192 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue
CountriesBangladesh

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 9, 2016
Enrollment StartMar 1, 2016
Primary CompletionAug 10, 2017
Study CompletionFeb 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.4 years ago

Interventions

TV005 vaccinebiological

Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.

Placebobiological

Delivered by subcutaneous injection