Estimation of Background Incidence Rates of Guillain-Barré Syndrome in Germany in the years 2007-2009 (BIGS)

Study identification

• EU PAS number:
  EUPAS6536
• Study ID:
  29016
• Official title and acronym:
  Estimation of Background Incidence Rates of Guillain-Barré Syndrome in Germany in the years 2007-2009 (BIGS)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Guillain-Barré syndrome (GBS) is currently the most frequent cause of acute flaccid paralysis worldwide and has been suggested to occur as a severe adverse reaction to several vaccines. An estimation of the age- and sex-specific background incidence rates of GBS constitutes a prerequisite for signal evaluation in the context of vaccine safety monitoring as well as for vaccine safety studies which to date is only insufficiently given in Germany. Referring to a request from the Paul Ehrlich Institute (PEI), which is responsible for the marketing authorization for vaccines in Germany, the main objective of the BIGS-Study was to estimate the background incidence of GBS in Germany in the years 2007-2009. A focus was set on age- and sex-specific incidence rates as well as on geographic (Western vs. Eastern Germany) and seasonal differences.
• Study status:
  Finalised

Research institutions and networks

Institutions

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Study timelines

Date when funding contract was signed

Planned:26/06/2012

Actual:26/06/2012

Study start date

Planned:01/01/2006

Actual:01/01/2006

Data analysis start date

Planned:01/10/2012

Actual:15/10/2013

Date of final study report

Planned:31/03/2013

Actual:15/04/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi Pasteur MSD

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)