Status: Finalised First registered on: 06/07/2016
Last updated on: 02/09/2019
1. Study identification
EU PAS Register NumberEUPAS13978
Official titleADVANCE POC I Benefit-Risk pillar – testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: benefit-risk analysis of pertussis vaccines in pre-school children comparing whole-cell and acellular formulations in the post-marketing setting
Study title acronymADVANCE POC I Benefit-Risk
Study typeOther: proof of concept feasibility 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?” The objectives of this specific benefit-risk modelling exercise, which focuses on testing methods for benefit-risk analysis with pertussis vaccines as test case, are the following: 1. To analyze the benefit-risk balance of pertussis-containing vaccines in children comparing wP and aP formulations at the time of the switch from wP to aP adopting a public health perspective (historical benefit-risk) 2. To investigate the impact of (1) statistical uncertainty in benefit and risk estimates as obtained from the literature, clinical trials, observational databases (uncertainty analyses), (2) differences in preferences and (3) subjective model choices (scenario analyses). 3. To identify the benefit and risk criteria that would most likely modify the benefit-risk balance in case they would change over time (i.e. the pivotal parameters). 4. To assess the feasibility of (retrospectively) monitoring the benefit-risk balance of pertussis-containing vaccines over time (this to mimic prospective monitoring) 5. To re-analyze the benefit-risk balance of pertussis-containing vaccines in children comparing wP and aP formulations from a public health perspective using all currently available evidence (current assessment).
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 Dr
Last name Bollaerts
First name Kaat
Is this study being carried out with the collaboration of a research network?
Yes
ADVANCE
Other centres where this study is being conducted
Not applicable (single centre)

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 analysis01/09/201601/09/2016
Date of interim report, if expected30/04/2017
Date of final study report01/02/201730/07/2017
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 Bollaerts
First name Kaat
Address line 1Koning Leopold III laan 1
Address line 2 
Address line 3 
CityLeuven 
Postcode3001 
CountryBelgium
Phone number (incl. country code)32-485789657 
Alternative phone number 
Fax number (incl. country code) 
Email address kaatje.bollaerts@p-95.com
Public Enquiries
Title Dr 
Last name Bollaerts 
First name Kaat 
Address line 1Koning Leopold III laan 1 
Address line 2 
Address line 3 
CityLeuven 
Postcode3001 
CountryBelgium 
Phone number (incl. country code)32-485789657 
Alternative phone number 
Fax number (incl. country code) 
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