Status: Ongoing First registered on: 02/08/2021
Last updated on: 16/09/2021
1. Study identification
EU PAS Register NumberEUPAS42328
Official titleBrand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe A contribution of COVIDRIVE, a public-private partnership to estimate brand-specific COVID-19 vaccine effectiveness in Europe.
Study title acronym
Study typeObservational study
Brief description of the studyThis protocol details a non-interventional study to estimate the effectiveness of COVID-19 vaccines against COVID-19 related hospitalisations through the COVIDRIVE partnership. In addition, the potential for vaccine-associated enhanced disease (VAED) will be studied as part of this vaccine effectiveness study as VAED relates to the efficacy/effectiveness outcomes. This is a prospective, multi-centre, hospital-based, case-control study with test-negative controls (test-negative case-control design). Data will be collected through a wide network of hospitals located in several European countries and the UK.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
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 nameCOVIDRIVE
Centre locationBelgium
Details of (Primary) lead investigator
Title Dr
Last name Bollaerts
First name Kaatje
Is this study being carried out with the collaboration of a research network?
Yes
COVIDRIVE
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2
FISABIO, Spain
CIRI-IT, Italy
Countries in which this study is being conducted
International study

Italy
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/08/2021
Start date of data collection15/08/202108/09/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report29/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca, Janssen100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Bollaerts
First name Kaatje
Address line 1Koning Leopold III laan 1
Address line 2 
Address line 3 
CityHeverlee 
Postcode3001 
CountryBelgium
Phone number (incl. country code)32485789657 
Alternative phone number 
Fax number (incl. country code) 
Email address kaatje.bollaerts@p-95.com
Public Enquiries
Title Mrs 
Last name Rebry 
First name Griet 
Address line 1Koning Leopold III laan 1 
Address line 2 
Address line 3 
CityHeverlee 
Postcode3100 
CountryBelgium 
Phone number (incl. country code)32479462164 
Alternative phone number 
Fax number (incl. country code) 
Email address Griet.rebry@p-95.com 
Top