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

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000218
• Study ID:
  1000000218
• Official title and acronym:
  A Nested Case-Control Post-Authorization Effectiveness Study: The Association Between Prior Exposure to Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Dengue Hospitalization in a Pediatric and Adolescent Population
• DARWIN EU® study:
  No
• Study countries:
  Indonesia

  Malaysia

  Thailand
• Study description:
  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).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Planned:14/08/2024

Actual:27/09/2024

Study start date

Planned:05/03/2025

Actual:05/03/2025

Data analysis start date

Planned:30/06/2029

Date of final study report

Planned:31/12/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

DEN-401, NCT06843226