National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)

Summary

National cohort study of effectiveness and safety of SARS-CoV-2 vaccines (ENFORCE is an equivalence trial to evaluate the effectiveness and safety of multiple new SARS-CoV-2 vaccines approved for use in the EU, and which are being offered at participating units. The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).

Timeline

Start

2021-02-08

Primary completion

2023-12-31

Completion

2023-12-31

Publications

• Staerke NB, Reekie J, Johansen IS, Nielsen H, Benfield T, Wiese L, Sogaard OS, Tolstrup M, Iversen KK, Tarp B, Larsen FD, Larsen L, Lindvig SO, Holden IK, Iversen MB, Knudsen LS, Fogh K, Jakobsen ML, Traytel AK, Ostergaard L, Lundgren J; ENFORCE Study Group. Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE). BMJ Open. 2022 Dec 30;12(12):e069065. doi: 10.1136/bmjopen-2022-069065.

Drugs

Indications