NCT04760132

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7,600 (actual)
• Sponsor: Jens D Lundgren, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

First phase will enrol 10,000 persons initiating vaccination (assuming 4 vaccines). If more vaccines become available additional 2,500 persons per vaccine will be included. Subsequent phases with larger sections of the population included may be implemented. Participants will have 6 study visits and be followed for 2 years after the first vaccination, which offers the participants an extra close follow up on vaccine effectiveness. Safety data will be collected at study visits until 3 months after the first vaccination. Research samples will be collected at each study visit during the two year follow-up

Conditions

• SARS-CoV Infection

Interventions

Type	Name	Description
BIOLOGICAL	COMIRNATY - BioNTech Manufacturing GmbH	Vaccination as part of the the Danish national government programme
BIOLOGICAL	COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH	Vaccination as part of the the Danish national government programme
BIOLOGICAL	COVID-19 Vaccine AstraZeneca suspension for injection	Vaccination as part of the the Danish national government programme

Timeline

• Start date: 2021-02-08
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-02-18
• Last updated: 2024-04-12

Locations

5 sites across 1 country: Denmark