A Pregnancy Registry to Evaluate the Safety of Dengue Vaccine among Inadvertently Exposed Pregnant Women and their Offsprings

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46441
• EU PAS number:
  EUPAS31210
• Study ID:
  46441
• Official title and acronym:
  A Pregnancy Registry to Evaluate the Safety of Dengue Vaccine among Inadvertently Exposed Pregnant Women and their Offsprings
• DARWIN EU® study:
  No
• Study countries:
  Brazil
• Study description:
  This will be a Pregnancy Registry Study that utilizes active identification and enrollment of a cohort of pregnant women of any age and their offsprings who were inadvertently exposed to CYD tetravalent dengue vaccine (CYD-TDV) anytime during the pregnancy or in the 30 days preceding their last menstrual period (i.e., periconceptional period). Data collection will utilize a hybrid approach comprised of the use of structured interviews supplemented by medical records review (primary data sources), and the use of health and mortality databases (secondary data sources).
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned: 07/10/2019

Actual: 26/05/2020

Study start date

Planned: 22/01/2022

Actual: 11/03/2022

Date of final study report

Planned: 21/08/2023

Actual: 08/07/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Initial protocol

rdct-dng16-protocol.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

DNG16,U1111-1212-3443,NCT04023708