Status:
COMPLETED
National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)
Lead Sponsor:
Jens D Lundgren, MD
Collaborating Sponsors:
Ministry of the Interior and Health, Denmark
Conditions:
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
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 larg...
Eligibility Criteria
Inclusion
- Written informed consent obtained before any trial related procedures are performed
- Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan)
- The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
Exclusion
- Male and female under the age of 18
- Any subgroup of individuals for which the vaccines are contraindicated
- Previous SARS-CoV-2 vaccination
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
7600 Patients enrolled
Trial Details
Trial ID
NCT04760132
Start Date
February 8 2021
End Date
December 31 2023
Last Update
April 12 2024
Active Locations (5)
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1
Aarhus Universitetshospital, Skejby
Aarhus, Aarhus N, Denmark, 8200
2
Aalborg Universityhospital Syd
Aalborg, Denmark, 9000
3
Hvidovre Hospital
Hvidovre, Denmark, 2600
4
Odense Universityhospital
Odense, Denmark, 5000