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

NCT06665035 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2025-07-15

No results posted yet for this study

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.

Conditions

  • Dengue Fever

Interventions

BIOLOGICAL

TDV

TDV SC injection.

OTHER

Placebo

Placebo SC injection.

Sponsors & Collaborators

Principal Investigators

  • Study Director Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
20 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2030-03-03
Completion
2030-03-03

Countries

  • Colombia
  • Thailand

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06665035 on ClinicalTrials.gov