CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 480 enrolled
Drug / intervention
TDV +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/NCT06060067
NCT06060067Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Subjects Aged 4 to 60 Years in India

Takeda·interventional·Posted Sep 29, 2023·Updated May 29, 2026

In Brief

A Phase 3 clinical trial evaluating TDV and Placebo for Healthy Volunteers. Completed, enrolled 480 participants across 10 sites.

Detailed Summary

The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months. Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study. During the study, participants will visit their study clinic 6 times.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesIndia
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedSep 29, 2023
Enrollment StartMar 29, 2024
Primary CompletionMay 5, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.8 years ago

Interventions

TDVbiological

TDV SC injection on Day 1 and Day 90 of the study

Placebobiological

Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study