Study identification

PURI

https://redirect.ema.europa.eu/resource/29016

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 institution and networks

Institutions

Contact details

Tania Schink

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of final study report

Planned:
Actual:
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)