114101 - Post-marketing safety study to assess the risk of spontaneous abortions in women exposed to Cervarix in the United Kingdom

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31662
• EU PAS number:
  EUPAS3310
• Study ID:
  31662
• Official title and acronym:
  114101 - Post-marketing safety study to assess the risk of spontaneous abortions in women exposed to Cervarix in the United Kingdom
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the UK, will be analysed in this study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Clinical Practice Research Datalink (CPRD)

United Kingdom

Networks

Clinical Practice Research Datalink General Practitioner OnLine Database

Study timelines

Date when funding contract was signed

Actual: 25/09/2012

Study start date

Actual: 19/11/2012

Data analysis start date

Actual: 12/08/2013

Date of final study report

Actual: 17/03/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

EPI-HPV-018 VS UK DB (114101) Protocol Amendment 1 (14-Mar-2013)_Protocol Blinding_14 June 2013

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)