Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000218

EU PAS number

EUPAS1000000218

Study ID

1000000218

Official title and acronym

DEN-401: 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

DARWIN EU® study

No

Study countries

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 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
First published:
01/02/2024
Institution

Contact details

Study Contact Takeda

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Takeda
Study protocol
Initial protocol

DEN-401-clinical-study-protocol-redact.pdf

English (1.37 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable