205639 - Meta-analysis of the risk of autoimmune thyroiditis diseases, Guillain-Barré Syndrome, and Inflammatory Bowel Disease with Cervarix Vaccination

Study identification

• EU PAS number:
  EUPAS13332
• Study ID:
  31659
• Official title and acronym:
  205639 - Meta-analysis of the risk of autoimmune thyroiditis diseases, Guillain-Barré Syndrome, and Inflammatory Bowel Disease with Cervarix Vaccination
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  The purpose of this study is to evaluate the risk of autoimmune thyroiditis diseases, Guillain-Barré Syndrome, and Inflammatory Bowel Disease after Cervarix Vaccination.The study will evaluate the risk of autoimmune thyroiditis diseases, Guillain-Barré Syndrome, and Inflammatory Bowel Disease after Cervarix Vaccination in females.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Actual: 22/04/2016

Study start date

Actual: 22/04/2016

Date of final study report

Actual: 01/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK Biologicals

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)