Status: Finalised First registered on: 29/06/2016
Last updated on: 24/11/2017
1. Study identification
EU PAS Register NumberEUPAS13908
Official titleADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and whole-cell pertussis-containing vaccines in preschool children
Study title acronymADVANCE Coverage POC
Study typeObservational study
Brief description of the studyThe overall ADVANCE 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”?
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 nameStatens Serum Institut
Centre locationArtillerivej 5, 2300 Copenhagen, Denmark
Details of (Primary) lead investigator
Title Dr
Last name Emborg
First name Hanne-Dorthe
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?7

ARS
THIN, UK
FISABIO, Spain
BIFAP, spain
SSI, Denmark
Countries in which this study is being conducted
International study

Denmark
Italy
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/10/201301/10/2013
Start date of data collection01/06/201601/06/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report15/09/201629/06/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGSK, SP, NOVARTIS, SP MSD, CRUCELL, PFIZER, TAKEDA50
Charities
Government body
Research councils
EU funding scheme
OtherIMI50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Emborg
First name Hanne-Dorthe
Address line 1Artillerivej 5
Address line 2 
Address line 3 
CityCopenhagen 
Postcode2300 
CountryDenmark
Phone number (incl. country code)45-32683937 
Alternative phone number 
Fax number (incl. country code) 
Email address hde@ssi.dk
Public Enquiries
Title Dr 
Last name Emborg 
First name Hanne-Dorthe 
Address line 1Artillerivej 5 
Address line 2 
Address line 3 
CityCopenhagen 
Postcode2300 
CountryDenmark 
Phone number (incl. country code)45-32683937 
Alternative phone number 
Fax number (incl. country code) 
Email address hde@ssi.dk 
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