Study identification

PURI

https://redirect.ema.europa.eu/resource/39316

EU PAS number

EUPAS39289

Study ID

39316

Official title and acronym

ACCESS template protocols for effectiveness of COVID-19 vaccines (ACCESS-effectiveness)

DARWIN EU® study

No

Study countries

Belgium
Denmark
France
Italy
Netherlands
Spain

Study description

This 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)

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

3e. Protocol_ACCESS Effectiveness TND Protocol

English (1.12 MB - PDF)View document
Updated protocol

3f. Protocol_ACCESS_COVID-19 EHR Vaccine Effectiveness Protocol Template

English (1.5 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable