COVIDRIVE Master protocol
- This master protocol describes a non-interventional study to estimate the effectiveness of COVID-19 vaccines against COVID-19 severe disease in Europe. The study is a multi-country, hospital-based, case-control study with test-negative controls (test-negative case-control design, TNCC).
- This master protocol has been developed by the COVIDRIVE public-private partnership. Comments received by the COVIDRIVE Independent Scientific Committee (ISC), the EMA and ECDC are reflected in version 2.3 and all subsequent versions of this protocol. Additional comments received by the COVIDRIVE ISC are also reflected in version 4.0.
- The COVIDRIVE master protocol developed by the consortium is publicly available (current version 4.0). View here
- The COVIDRIVE master protocol is also available at the EU PAS register of ENCePP (EU-PAS 42328)
The historic of approved COVIDRIVE master protocols can be consulted below:
COVIDRIVE master protocol V3.1
COVIDRIVE master protocol V3.3