Status: Finalised First registered on: 14/05/2014
Last updated on: 21/03/2019
1. Study identification
EU PAS Register NumberEUPAS6536
Official titleEstimation of Background Incidence Rates of Guillain-Barré Syndrome in Germany in the years 2007-2009
Study title acronymBIGS
Study typeObservational study
Brief description of the studyGuillain-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.
Was this study requested by a regulator?Yes: Germany
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.uni-bremen.de
Details of (Primary) lead investigator
Title Dr
Last name Schink
First name Tania
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed26/06/201226/06/2012
Start date of data collection01/01/200601/01/2006
Start date of data analysis01/10/201215/10/2013
Date of interim report, if expected
Date of final study report31/03/201315/04/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSanofi Pasteur MSD100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schink
First name Tania
Address line 1Achterstraße 30
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany
Phone number (incl. country code)004942121856865 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de
Public Enquiries
Title Dr 
Last name Schink 
First name Tania 
Address line 1Achterstraße 30 
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany 
Phone number (incl. country code)004942121856865 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de 
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