A Study in Children and Teenagers to Learn if a TDV Dengue Vaccination Lowers the Chance of Hospital Stays for Dengue

NCT06843226 | Recruiting

• 2 other identifiers: DEN-401EUPAS1000000218
• Study Type: observational
• Target: 70,000
• Locations: 3 countries
• Sites: 7

Brief Summary

The main aim of this study is to collect more information on the effectiveness of TDV when used in a pilot public vaccination program for children and adolescents participating in a community-based cohort in Southeast Asian countries with high dengue transmission, specifically Thailand, Indonesia, and Malaysia where TDV is already approved for use. The study will include cohort participants (individual follow-up of 3 years) who may or may not later be vaccinated with TDV as part of a pilot public vaccination program in the study countries. The study will investigate if cohort participants who were vaccinated with TDV have less hospital stays due to dengue than cohort participants who were not vaccinated with TDV. The study will also provide further information on the effectiveness of TDV against the least common dengue virus serotypes (DENV-3 and DENV-4).

Conditions

Dengue Fever

Keywords

Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)

Outcome Measures

Primary Outcomes (1)

• Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants

  Number of participants hospitalized due to VCD of any dengue serotype in unvaccinated and fully vaccinated participants.

  Up to Month 36

Secondary Outcomes (3)

• Hospitalization Due to VCD By Each Infecting Dengue Serotype (DENV-1, DENV-2, DENV-3, DENV-4) in Unvaccinated and Fully Vaccinated Participants

  Up to Month 36

• Hospitalization Due to VCD by Baseline Dengue Serostatus (Seronegative and Seropositive) of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants

  Up to Month 36

• Hospitalization Due to VCD By Each Infecting Dengue Serotype and Baseline Dengue Serostatus in Unvaccinated and Fully Vaccinated Participants

  Up to Month 36

Study Arms (1)

Nested Case-control Participants

The cohort will include case and control participants. Case participants who are hospitalized and meet the study inclusion and exclusion criteria for cases, have CDD, and have a confirmed positive RT-PCR test result (VCD) will be ascertained by active hospital surveillance. Control participants who are matched to a case and meet the study inclusion and exclusion criteria for controls but have not been hospitalized with VCD on or before their case's index date (first date of hospitalization for CDD for potential cases) will be interviewed.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

Nested Case-control Participants

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric and/or adolescent residents in the study area who are age-eligible for vaccination with TDV as part of a pilot public vaccination program (children 7-10 years in Thailand, 6-10 years in Indonesia, and 7-12 years in Malaysia).

You may qualify if:

• Cohort:
• The participant is a child or adolescent eligible to be vaccinated with TDV as part of a vaccination program planned in the study area.
• The participant's family do not intend to migrate away from the cohort hospital catchment area within 3 years of his/her enrollment into the study cohort.
• The participant's parent(s) or legally acceptable representative (LAR) signs and dates a written informed consent form (ICF), and any required privacy authorization where applicable, prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
• The participant signs and dates an age-appropriate assent form prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
• The participant's parent(s) or LAR agrees that a baseline blood sample may be taken from the participant.
• Cases:
• The participant is part of the cohort.
• The participant is hospitalized and clinically diagnosed with dengue.
• The participant has a blood sample available that was taken preferably within 5 days of fever onset and/or onset of symptoms compatible with dengue.
• The participant tested positive for dengue by RT-PCR.
• Controls:
• The participant is part of the cohort.
• The participant had not been hospitalized with VCD at any point between enrollment in the cohort and the index date (that is, when his/her matched case was hospitalized with CDD).
• The participant is a resident in the same neighbourhood as the matched case.

You may not qualify if:

• Cases:
• The participant has been vaccinated with TDV, a tetravalent, live attenuated, chimeric dengue vaccine in a yellow fever 17D backbone (CYD-TDV), or an investigational dengue vaccine prior to cohort enrollment.
• Contraindications as per the locally approved label/product information leaflet.
• Controls:
• The participant has been vaccinated with TDV, CYD-TDV, or an investigational dengue vaccine prior to cohort enrollment.
• Contraindications as per the locally approved label/product information leaflet.
• The participant could not be contacted at the time of being selected as a control.

Sponsors & Collaborators

• Takeda: lead

Study Sites (7)

Fakultas Kedokteran Lambung Mangkurat

Banjarmasin, South Kalimantan, 70122, Indonesia

RECRUITING

Fakultas Kedokteran Universitas Sriwijaya

Palembang, South Sumatra, 30662, Indonesia

RECRUITING

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, 10430, Indonesia

RECRUITING

Universiti Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

NOT YET RECRUITING

Pattaya Patamakhun Hospital

Chon Buri, 20150, Thailand

ACTIVE NOT RECRUITING

Nakhon Phanom Hospital

Nakhon Phanom, 48000, Thailand

ACTIVE NOT RECRUITING

Phra Nakhon Si Ayutthaya Hospital

Phra Nakhon Si Ayutthaya, 13000, Thailand

ACTIVE NOT RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) baseline testing for the cohort participants participating in the nested case control investigation and reverse transcription polymerase chain reaction (RT PCR) testing for clinically diagnosed dengue (CCD) hospitalised cohort participants to confirm virologically confirmed dengue (VCD).

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 24, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

TH (3); MY (1); ID (3)