Status: Planned First registered on: 17/06/2022
Last updated on: 17/06/2022
1. Study identification
EU PAS Register NumberEUPAS47725
Official titleEffectiveness of heterologous and booster Covid-19 vaccination in 5 European countries, using a cohort approach in children and adults with a full primary Covid-19 vaccination regimen
Study title acronymCovid Vaccines Effectiveness (CoVE)
Study typeObservational study
Brief description of the studyReal-world effectiveness data demonstrated that Covid-19 vaccines' protection against severe SARS-CoV-2 infection is high in the short term but wanes over time, also depending on the virus variants. This study will deepen the real-world data effectiveness evidence of heterologous, homologous, and booster vaccination different regimes on a large population scale. The goal of this study is to assess the effectiveness and waning of immunity of primary Covid-19 vaccinations and the booster in preventing different covid-19 outcomes. The Primary objective is to estimate the effectiveness and waning of effectiveness in adults and adolescents (heterologous vs homologous primary vaccinations), children (vaccinations vs non-vaccination), homologous or heterologous booster vs no booster. Secondary objective: To estimate the effectiveness of booster against all-cause mortality in adults 60+. Retrospective multi-database cohort study. Cohort entry (time0) is the date of the 2nd dose for the primary vaccination regimens, or the booster. The same date for pairs who are matched on time0, birth year, sex and region. Outcomes: severe Covid-19, Covid-19-related death, all Covid-19 infections, and all-cause mortality. The study will include 8 data sources across from Spain, Italy, Netherlands, France, and United Kingdom. The population are estimated in around 67 millions patients with complete primary vaccination. Baseline characteristics, Incident rates differences and IPW Kaplan-Meier curves for covid outcomes by matched cohorts will be estimated. Vaccine effectiveness will be estimated as 1 minus the Hazard Ratio (estimated by Cox regression) for age groups, overall matched cohorts, and brands. Meta-analyses will be performed for small subpopulations. Different access to Covid-19 testing (restricting to patients with negative tests) and healthy vaccinee effect will be investigated in sensitivity analyses.
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 applicableThe project has received support from the European Medicines Agency under the Framework service contract nr EMA/2020/46/TDA/L5.06
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsAEMPS
Department/Research groupPharmacoepidemiology and Pharmacovigilance department
Organisation/affiliationSpanish Agency of medicines and medical devices
Website/Homepagehttp://www.aemps.gob.es/
Details of (Primary) lead investigator
Title Dr
Last name Martín Merino
First name Elisa
Is this study being carried out with the collaboration of a research network?
Yes

EU PE&PV research network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?17

ARS
l’Assistance Publique-Hôpitaux de Paris (APHP), France
Teamit Institute, S.L., Spain
PHARMO Institute for Drug Outcomes Research., Netherland
Società Servizi Telematici -Pedianet., Italy
Institute of Public Health, Riga Stradins University, Latvia
Democritus University of Thrace, Greece
National Public Health Agency (RIVM), Netherlands
Countries in which this study is being conducted
International study

France
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/04/2022
Start date of data collection20/06/2022
Start date of data analysis
Date of interim report, if expected
Date of final study report20/09/2022
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 schemeEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Martín Merino
First name Elisa
Address line 1Parque Empresarial Las Mercedes
Address line 2C/Campezo 1 edificio 8 
Address line 3 
CityMadrid 
Postcode28022 
CountrySpain
Phone number (incl. country code)34918225264 
Alternative phone number 
Fax number (incl. country code) 
Email address emartinm@aemps.es
Public Enquiries
Title Dr 
Last name Martín Merino 
First name Elisa 
Address line 1Parque Empresarial Las Mercedes 
Address line 2C/Campezo 1 edificio 8 
Address line 3 
CityMadrid 
Postcode28022 
CountrySpain 
Phone number (incl. country code)34918225264 
Alternative phone number 
Fax number (incl. country code) 
Email address emartinm@aemps.es 
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