CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 900 enrolled
Drug / intervention
YF-17D +2 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/NCT03342898
NCT03342898Phase 3Completed

A Randomized, Observer-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of a Tetravalent Dengue Vaccine Candidate and a Yellow Fever YF-17D Vaccine Administered Concomitantly and Sequentially in Healthy Subjects Aged 18 to 60 Years in Non-Endemic Country(Ies)

Takeda·interventional·Posted Nov 17, 2017·Updated Oct 8, 2020

In Brief

A Phase 3 clinical trial evaluating YF-17D, TDV, and 1 other intervention for Dengue. Completed, enrolled 900 participants across 11 sites.

Detailed Summary

The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both dengue and YF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartFeb 28, 2018
Primary CompletionMay 9, 2018
Study CompletionMay 22, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.6 years ago

Interventions

YF-17Dbiological

YF-17D SC injection.

TDVbiological

TDV SC injection.

Placebodrug

Normal Saline (0.9% NaCl) SC injection.