Loading clinical trials...

A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06665035•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.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant eligibility is determined according to the following criteria:
•1. Participant is aged \>=6 to \<21 months at the time of entry into the trial.
•2. Participant is male or female.
•3. Participant is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator.
•4. Participant's legally acceptable representative (LAR) has signed and dated a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedure, and after the nature of the trial has been explained according to local regulatory requirements.
•5. The participant and participant's LAR can comply with trial procedures and can be available for the duration of follow-up, according to the LAR.

Exclusion Criteria

•Any participant who meets any of the following criteria will not qualify for randomization:
•1. Participant has contraindication(s), warning(s) and/or precaution(s) applicable to vaccination with TDV as specified in the investigator's brochure (IB)and/or the approved product label (as applicable) in the participating country.
•2. Participant has a known hypersensitivity or allergy to any of the investigational medicinal product (IMP) components (including excipients).
•3. Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.
•4. Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
•5. Participant has an illness, or history of any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participant due to involvement in this trial.
•6. Participant has a known or suspected impairment/alteration of immune function, including:
•1. Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, \>=2 mg/kg \[milligrams per kilograms\] body weight/day prednisone \[or equivalent\] for 14 consecutive days, or, \>=20 milligram per day \[mg/day\] prednisone \[or equivalent\] for \>=14 consecutive days) within 60 days prior to Day 1 month 0 (M0) (note: use of corticosteroids by inhaled, intranasal, intraarticular, bursal, tendon injection, or topical routes is allowed).
•2. Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within the 3 months prior to Day 1 (M0).
•3. Receipt of immunostimulants within 60 days prior to Day 1 (M0).
+19 more criteria

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

Key Dates

Start Date

June 16, 2025

Primary Completion Date

March 3, 2030

Completion Date

March 3, 2030

Last Updated

July 15, 2025

Enrollment

212

ESTIMATED participants

Conditions

Dengue Fever

Interventions

TDV

BIOLOGICAL

Placebo

OTHER

Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

NCT07007585

DengueDengue Fever+1 more

View study

RECRUITING

A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia

NCT06388785

Dengue Fever

View study

COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia

A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in Japan

A Cluster-randomized Trial to EValuate the Efficacy of Wolbachia-InfecTed Aedes Aegypti Mosquitoes in Reducing the Incidence of Arboviral Infection in Brazil (EVITA Dengue)

Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections

Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose