Status: Finalised First registered on: 31/01/2021
Last updated on: 02/02/2021
1. Study identification
EU PAS Register NumberEUPAS39289
Official titleACCESS template protocols for effectiveness of COVID-19 vaccines
Study title acronymACCESS-effectiveness
Study typeObservational study
Brief description of the studyThis registration comprises 2 template protocols from the ACCESS project to monitor COVID-19 vaccine effectiveness. They differ as regards the methods and the data collection. These template protocols can be adapted to the local situation 1. Test negative case control design based on primary data collection (written by Fisabio) 2. Retrospective cohort study to monitor effectiveness of COVID-19 vaccine (written by RTI-HS)
Was this study requested by a regulator?Yes: EMA
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 belongsUMCU
Department/Research groupJulius Center
Organisation/affiliationUniversity Medical Center Utrecht
Website/Homepagewww.umcutrecht.nl
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes

VAC4EU
EU PE & PV network
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Belgium
Denmark
France
Italy
Netherlands
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/05/202021/05/2020
Start date of data collection22/05/202022/05/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report15/12/202015/12/2020
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 scheme
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1Heidelberglaan 100
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands
Phone number (incl. country code)31657831983 
Alternative phone number 
Fax number (incl. country code) 
Email address m.c.j.sturkenboom@umcutrecht.nl
Public Enquiries
Title Professor 
Last name Sturkenboom 
First name Miriam 
Address line 1Heidelberglaan 100 
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31657831983 
Alternative phone number 
Fax number (incl. country code) 
Email address m.c.j.sturkenboom@umcutrecht.nl 
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