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A Study in Children and Teenagers to Learn if a TDV Dengue Vaccination Lowers the Chance of Hospital Stays for Dengue
Sponsor: Takeda
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).
Official title: 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
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
OBSERVATIONAL
Enrollment
70000
Start Date
2025-03-05
Completion Date
2029-12-31
Last Updated
2026-04-16
Healthy Volunteers
Yes
Conditions
Interventions
No 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