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RECRUITING
NCT06579755
PHASE3

A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)

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. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition. In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first). During the study, participants will visit their study clinic 5 times.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled (Older Adults, Aged >60 to 79 Years) and Open-Label (Adults, Aged 45 to 60 Years), Multicenter Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (TDV) Administered Subcutaneously to Adults and Older Adults With or Without Comorbidities in Endemic Areas for Dengue

Key Details

Gender

All

Age Range

45 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2026-01-20

Completion Date

2027-04-14

Last Updated

2026-02-09

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

TDV

TDV SC injection.

OTHER

Placebo

Placebo SC injection.

Locations (7)

Fundacion Huesped - PPDS

Buenos Aires, Argentina

Associacao Obras Sociais Irma Dulce Hospital Santo Antonio

Salvador, Estado de Bahia, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

São José do Rio Preto, São Paulo, Brazil

Singapore General Hospital (SGH)

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Ramathibodi Hospital

Ratchathewi, Bangkok, Thailand

Hospital for Tropical Diseases

Ratchathewi, Krung Thep Maha Nakhon-Bangkok, Thailand