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

April 10, 2024 updated by: Jens D Lundgren, MD

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

7600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universityhospital Syd
      • Hvidovre, Denmark, 2600
        • Hvidovre Hospital
      • Odense, Denmark, 5000
        • Odense Universityhospital
      • Roskilde, Denmark, 4000
        • Sjællandsuniversitetshospital
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Written informed consent obtained before any trial related procedures are performed
  2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan)
  3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)

Exclusion Criteria:

  1. Male and female under the age of 18
  2. Any subgroup of individuals for which the vaccines are contraindicated
  3. Previous SARS-CoV-2 vaccination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vaccine A - COMIRNATY COVID-19 vaccine
COMIRNATY (COVID-19, mRNA Vaccine) by BioNTech Manufacturing GmbH Marketing Authorisation EU/1/20/1528
Biological: COMIRNATY - BioNTech Manufacturing GmbH
Vaccination as part of the the Danish national government programme
Active Comparator: Vaccine B - Moderna COVID-19 vaccine

COVID-19 Vaccine Moderna dispersion for injection (COVID-19, mRNA Vaccine) by MODERNA BIOTECH SPAIN S.L.

Marketing Authorisation EU/1/20/1507/001
Biological: COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH
Vaccination as part of the the Danish national government programme
Active Comparator: Vaccine C - Astra-Zeneca COVID-19 vaccine
COVID-19 Vaccine AstraZeneca suspension for injection (ChAdOx1-S [recombinant]) by AstraZeneca AB Marketing Authorisation EU/1/21/1529/001 and /002
Biological: COVID-19 Vaccine AstraZeneca suspension for injection
Vaccination as part of the the Danish national government programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines
Time Frame: The change from Base-line in MPNAT measured via profiling of antibodies against SARS-CoV-2 Spike epitopes at 24 month
Primary outcome is the minimal protective neutralising antibody titre (MPNAT); i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected.
The change from Base-line in MPNAT measured via profiling of antibodies against SARS-CoV-2 Spike epitopes at 24 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines
Time Frame: The change from first vaccination until 24 month
Number of confirmed positive SARS-CoV-2 tests reported via the national testing system.
The change from first vaccination until 24 month
Assessment of the safety of the vaccines will be compared between groups
Time Frame: From first vaccine until Day 90
Reports of participants with local and systemic reactions to the vaccination will be collected
From first vaccine until Day 90
Assessment of any Adverse Event from the vaccines will be compared between groups
Time Frame: From first vaccine until Day 90
Reports of participants with grade 3 and 4 Adverse Events and any Serious Adverse will be collected
From first vaccine until Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens D Lundgren, MD

Collaborators

Ministry of the Interior and Health, Denmark

Investigators

  • Study Chair: Jens Lundgren, Professor, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENFORCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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