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ACTIVE NOT RECRUITING
NCT07047521
PHASE3

A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV. Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.

Official title: A Randomized, Double-Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of a New Formulation of Tetravalent Dengue Vaccine (TDV) Versus the Current Formulation of TDV in Healthy Adults (Aged 18-60 Years) in a Non-Endemic Area for Dengue

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

496

Start Date

2025-11-07

Completion Date

2027-07-30

Last Updated

2026-02-12

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Tetravalent Dengue Vaccine (TDV)

TDV subcutaneous injection

Locations (5)

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, Australia

Emeritus Research Sydney

Botany, New South Wales, Australia

Paratus Clinical Research Central Coast

Kanwal, New South Wales, Australia

Veritus Research

Bayswater, Victoria, Australia

Emeritus Research Camberwell (Melbourne)

Camberwell, Victoria, Australia