The MenQuadfi™ Pregnancy Registry: A surveillance registry to assess the safety of MenQuadfi™ among exposed pregnant women and their offspring (MEQ00070)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38094
• EU PAS number:
  EUPAS38093
• Study ID:
  38094
• Official title and acronym:
  The MenQuadfi™ Pregnancy Registry: A surveillance registry to assess the safety of MenQuadfi™ among exposed pregnant women and their offspring (MEQ00070)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The primary objective of the pregnancy registry will be to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi™ during pregnancy or in the 30 days preceding their last menstrual period (LMP).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned: 22/07/2020

Actual: 22/07/2020

Study start date

Planned: 05/04/2021

Actual: 05/03/2021

Date of final study report

Planned: 01/02/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

MEQ00070