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RECRUITING
NCT06843226

A Study in Children and Adolescents on the Effectiveness of Takeda's Licensed Dengue Vaccine TDV Against Hospitalization Due to Dengue Disease

Sponsor: Takeda

View on ClinicalTrials.gov

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 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

Any - 18 Years

Study Type

OBSERVATIONAL

Enrollment

70000

Start Date

2025-03-05

Completion Date

2029-12-31

Last Updated

2025-09-03

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

No Intervention

This is a non-interventional study.

Locations (3)

Pattaya Patamakhun Hospital

Bang Lamung, Changwat Chon Buri, Thailand

Nakhon Phanom hospital

Nakhon Phanom, Changwat Nakhon Phanom, Thailand

Phra Nakhon Si Ayutthaya Hospital

Mueang Phra Nakhon Si Ayutthaya, Phra Nakhon Si Ayutthaya, Thailand