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RECRUITING
NCT06665035
PHASE3

A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers

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 purpose of this study is to collect information of vaccination with TDV when given to children younger than 2 years. The main aims of this study are to learn how safe the vaccine is and how well it works to activate a young child's immune system (this is called immunogenicity). Children between the age of 6 and 21 months will receive two vaccinations with either TDV or placebo 3 months apart. Blood samples will be taken before and after the vaccination as well as throughout the study. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 8 times for vaccinations, blood draws and health checks.

Official title: A Randomized, Age-Descending, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Immunogenicity of 2 Doses of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Within the Routine Vaccination Schedule of Pediatric Participants ≥6 Months to <21 Months of Age

Key Details

Gender

All

Age Range

6 Months - 20 Months

Study Type

INTERVENTIONAL

Enrollment

212

Start Date

2025-06-16

Completion Date

2030-03-03

Last Updated

2025-07-15

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

TDV

TDV SC injection.

OTHER

Placebo

Placebo SC injection.

Locations (4)

Clinica de la Costa Ltda

Barranquilla, Atlántico, Colombia

Centro de Estudios en Infectologia Pediatrica S.A.S

Cali, Valle del Cauca Department, Colombia

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, Thailand