Post-Authorization Safety Study Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine (DNG15-Post Authorisation safety Surveillance study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48340
• EU PAS number:
  EUPAS28947
• Study ID:
  48340
• Official title and acronym:
  Post-Authorization Safety Study Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine (DNG15-Post Authorisation safety Surveillance study)
• DARWIN EU® study:
  No
• Study countries:
  Brazil

  Mexico

  Philippines
• Study description:
  DNG15 is a prospective multi-national non-interventional study that includes two components of Cohort Event Monitoring (CEM): ; 1. Short-term safety surveillance with a follow-up of 6 months after each Dengvaxia® dose administration followed by, ; 2. Long-term safety surveillance with a follow-up of five years after the first dose.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Actual: 24/11/2016

Study start date

Actual: 13/12/2016

Date of final study report

Planned: 05/09/2023

Actual: 05/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

sanofi pasteur

Study protocol

Initial protocol

rdct-dng15-amended-protocol10.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

DNG15 - NCT02948933