Study on How TDV Dengue Vaccine Affects Hospital Stays for Dengue in Children and Adolescents Aged 6 to 12 in Southeast Asia

What this Trial Is About

Researchers are studying the effectiveness of a tetravalent dengue vaccine TDV in reducing hospital stays due to dengue in children and adolescents aged 6 to 12 years living in Southeast Asian countries with high dengue transmission, including Thailand, Indonesia, and Malaysia. This observational study focuses on participants in a community-based cohort who may or may not receive the vaccine as part of a pilot public vaccination program where TDV is already approved. The study particularly aims to assess the vaccines effectiveness against less common dengue virus types DENV-3 and DENV-4. The study includes a nested case-control design with two groups cases who are hospitalized children or adolescents with confirmed dengue infection, and matched controls who live in the same neighborhood but have not been hospitalized with dengue. Participants are followed individually for up to 3 years within the cohort. The study is non-interventional, observing outcomes based on vaccination status within the existing vaccination program. Participants will be monitored through active hospital surveillance to identify dengue hospitalizations confirmed by laboratory testing. Data collected includes blood samples for RT-PCR testing, clinical diagnosis, and hospitalization records. Researchers will measure the rate of hospitalization due to dengue virus infections by serotype and baseline dengue immune status. The primary outcome is dengue-related hospitalization up to 36 months. Parents or legal representatives provide consent and assent for participants, including agreement for blood sample collection and follow-up over the study period.

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