Status: Finalised First registered on: 10/06/2016
Last updated on: 27/11/2017
1. Study identification
EU PAS Register NumberEUPAS13766
Official titleTesting new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children
Study title acronymbenefit study on pertussis vaccinatoin
Study typeObservational study
Brief description of the studyThe overall proof-of-concept (POC) question is to test the system for benefit-risk monitoring of vaccines in Europe. This will first be done by using test cases. For this POC, the following research question is used: “Has the initial benefit-risk profile in children prior to school-entry booster been maintained after the switch from whole-cell pertussis vaccines to acellular pertussis vaccines”? There will we 3 different POCs carried out, the one presented here will test the benefits of pertussis vaccines in the population.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsP95
Department/Research group
Organisation/affiliationP95
Website/Homepagewww.P-95.com
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes
ADVANCE
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?10

IDIAPJGol
UMCU
IMS Health
P95
VACCINE.GRID
Erasmus MC Pharmacoepi
AEMPS
Countries in which this study is being conducted
International study

Denmark
Italy
Netherlands
Spain
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/10/201331/10/2013
Start date of data collection02/04/201601/10/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report31/10/201630/07/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSanofi Pasteur, GSK, MSD Sanofi Pasteur50
Charities
Government body
Research councils
EU funding schemeIMI50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lisen
First name Arnheim Dahlström
Address line 1Dept. of medical epidemiology and biostatistics
Address line 2Nobels väg 12a 
Address line 3Karolinska Institutet 
CityStockholm 
Postcode17177 
CountrySweden
Phone number (incl. country code)46-70-9495221 
Alternative phone number 
Fax number (incl. country code) 
Email address lisen.arnheim.dahlstrom@ki.se
Public Enquiries
Title Professor 
Last name Sturkenboom 
First name Miriam 
Address line 1Seminarriehof 8 
Address line 2 
Address line 3 
CitySoest 
Postcode3768EE 
CountryNetherlands 
Phone number (incl. country code)31-6-57831983 
Alternative phone number 
Fax number (incl. country code) 
Email address mcjm.sturkenboom@gmail.com 
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