Post-Marketing surveillance for the safety of GARDASIL® and GARDASIL®9 in a cohort of Chinese women

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47294
• EU PAS number:
  EUPAS36132
• Study ID:
  47294
• Official title and acronym:
  Post-Marketing surveillance for the safety of GARDASIL® and GARDASIL®9 in a cohort of Chinese women
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This is a database study using the Ningbo Regional Health Information Platform to monitor the occurrence of autoimmune disorders and adverse pregnancy outcomes in GARDASIL® or GARDASIL®9 vaccinated women in Ningbo, China.
• Study status:
  Finalised

Research institution and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 28/09/2020

Study start date

Planned: 01/06/2021

Actual: 15/03/2021

Data analysis start date

Planned: 31/03/2022

Actual: 14/03/2022

Date of final study report

Planned: 28/04/2023

Actual: 21/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

V503-055_Redacted Protocol red

Regulatory

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