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

StatusRecruiting
PhasePhase 3
SponsorTakeda
Started2025-06-16
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 3 times since 2024-10-29; most recent filed 2026-06-24. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-06-24
Amendment Study Status, References v3
2025-07-10
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v2
2025-04-11
Amendment Study Status, Oversight v1
2024-10-29
Original filing
Trial Details
NCT Number NCT06665035
Lead Sponsor Takeda
Conditions Dengue Fever
Enrollment 212 participants
Start Date 2025-06-16
Primary Completion 2030-03-03 (estimated)
Study Completion 2030-03-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-29