RecruitingNCT06843226

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

The Association Between Prior Exposure to Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Dengue Hospitalization in a Pediatric and Adolescent Population: A Nested Case-Control Post-Authorization Effectiveness Study


Sponsor

Takeda

Enrollment

70,000 participants

Start Date

Mar 5, 2025

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 6 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying No Intervention for people with dengue fever. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo Intervention

This is a non-interventional study.


Locations(7)

Fakultas Kedokteran Lambung Mangkurat

Banjarmasin, South Kalimantan, Indonesia

Fakultas Kedokteran Universitas Sriwijaya

Palembang, South Sumatra, Indonesia

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, Indonesia

Universiti Malaya Medical Centre

Kuala Lumpur, Malaysia

Pattaya Patamakhun Hospital

Chon Buri, Thailand

Nakhon Phanom Hospital

Nakhon Phanom, Thailand

Phra Nakhon Si Ayutthaya Hospital

Phra Nakhon Si Ayutthaya, Thailand

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NCT06843226


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