NCT06843226

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70,000 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2025-03-05
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-02-24
• Last updated: 2026-04-16

Locations

7 sites across 3 countries: Indonesia, Malaysia, Thailand