Status: Finalised First registered on: 14/06/2016
Last updated on: 22/11/2017
1. Study identification
EU PAS Register NumberEUPAS13779
Official titleADVANCE POC I Risk pillar - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of safety outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children
Study title acronymADVANCE POC I Risk
Study typeOther: Proof of concept feasibiliy study
Brief description of the studyRATIONALE: The ADVANCE proof-of-concept (POC) question is to test the system for benefit-risk monitoring of vaccines in Europe. For this POC feasibility study, the research question “Has the initial benefit-risk profile in children prior to school-entry booster been maintained after the switch from whole-cell pertussis (wP) vaccines to acellular pertussis (aP) vaccines?” is used. OBJECTIVES: 1. To evaluate participating databases on quality criteria for inclusion in the study. 2. To provide incidence rates of specific events (i.e. injection site reactions, fever, somnolence, persistent crying, irritability, febrile or afebrile seizure/convulsion, hypotonic-hyporesponsive episode [HHE], extensive limb swelling) within risk periods after each dose of wP or aP vaccine and within the periods outside the risk windows (baseline) in pre-school children for a benefit/risk analysis model. 3. To provide calendar time specific incidence data as test for methods development in ADVANCE WP4. STUDY DESIGN: is a retrospective dynamic cohort study. The study will be conducted utilizing electronic health care data from ADVANCE partners in different European countries POPULATION: The study population will comprise all children registered in any of the participating databases during the study period and for whom an adequate start and end of follow-up and date of birth can be defined. Children will be followed from start of the study period, one month after date of birth, or date of valid data in the database (whichever is the latest) until the end of study period (31-12-2015, the school-entry pertussis booster, transferring out of the database, death, reaching age 6 years: whichever is the earliest). Data Analysis: incidence rates (i.e. baseline and risk-window specific) of known adverse reactions following vaccination with pertussis-containing vaccines for use in a multi-criteria decision analysis (MCDA) model of benefits and risks of wP versus aP 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 to which the investigator belongsErasmus MC Pharmacoepi
Department/Research groupPharmacoepidemiology Erasmus University
Organisation/affiliationErasmus University Medical Center
Website/Homepagewww.erasmusmc.nl
Details of (Primary) lead investigator
Title Dr
Last name Weibel
First name Daniel
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?6

IDIAPJGol
ARS
SSI, Denmark
BIFAP, Spain
FISABIO, Spain
THIN, UK
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 report01/06/201617/08/2017
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 body
Research councils
EU funding schemeIMI100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Weibel
First name Daniel
Address line 1POBOX 2040
Address line 2dep. Medical Informatics 
Address line 3 
CityRotterdam 
Postcode3000 CA 
CountryNetherlands
Phone number (incl. country code)31107037889 
Alternative phone number 
Fax number (incl. country code) 
Email address d.weibel@erasmusmc.nl
Public Enquiries
Title Dr 
Last name Weibel 
First name Daniel 
Address line 1POBOX 2040 
Address line 2dep. Medical Informatics 
Address line 3 
CityRotterdam 
Postcode3000 CA 
CountryNetherlands 
Phone number (incl. country code)31107037889 
Alternative phone number 
Fax number (incl. country code) 
Email address d.weibel@erasmusmc.nl 
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