Status: Planned First registered on: 23/01/2015
Last updated on: 23/01/2015
1. Study identification
EU PAS Register NumberEUPAS8429
Official titleGuillain-Barré syndrome and influenza vaccines: a meta-analysis
Study title acronym
Study typeObservational study
Brief description of the studyCases of Guillain-Barré syndrome (GBS) have been occasionally associated with influenza vaccines; this possible risk, even if rare, is a matter of much concern. To learn the strength of this association, a systematic review and a meta-analysis will be conducted. Controlled observational studies addressing the risk of GBS associated with different influenza vaccines will be sought and eventually included.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 belongsCESME
Department/Research groupCentro de Estudios sobre la Seguridad de los Medicamentos
Organisation/affiliationUniversidad de Valladolid
Website/Homepagewww.uva.es/cesme
Details of (Primary) lead investigator
Title Professor
Last name Carvajal
First name Alfonso
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

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed09/01/2013
Start date of data collection15/05/2013
Start date of data analysis
Date of interim report, if expected
Date of final study report03/02/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyUniversidad de Valladolid100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Carvajal
First name Alfonso
Address line 1Ramón y Cajal 7
Address line 2 
Address line 3 
CityValladolid 
Postcode47005 
CountrySpain
Phone number (incl. country code)34-983263021 
Alternative phone number 
Fax number (incl. country code)34983254924 
Email address carvajal@ife.uva.es
Public Enquiries
Title Professor 
Last name Carvajal 
First name Alfonso 
Address line 1Ramón y Cajal 7 
Address line 2 
Address line 3 
CityValladolid 
Postcode47005 
CountrySpain 
Phone number (incl. country code)34-983263021 
Alternative phone number 
Fax number (incl. country code)34983254924 
Email address carvajal@ife.uva.es 
Top