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

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ClinicalTrials.gov Identifier: NCT04760132
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 26, 2021
Sponsor:
Collaborator:
Ministry of the Interior and Health, Denmark
Information provided by (Responsible Party):
Jens D Lundgren, MD, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE February 8, 2021
First Posted Date  ICMJE February 18, 2021
Last Update Posted Date February 26, 2021
Actual Study Start Date  ICMJE February 8, 2021
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2021)
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)
Official Title  ICMJE National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines
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 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE SARS-CoV Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Vaccine A - COMIRNATY COVID-19 vaccine
    COMIRNATY (COVID-19, mRNA Vaccine) by BioNTech Manufacturing GmbH Marketing Authorisation EU/1/20/1528
    Intervention: Biological: COMIRNATY - BioNTech Manufacturing GmbH
  • 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

    Intervention: Biological: COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH
  • 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
    Intervention: Biological: COVID-19 Vaccine AstraZeneca suspension for injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2021)
10000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dorthe Raben +45 3545 5757 dorthe.raben@regionh.dk
Contact: Charlotte B Nielsen +45 3545 5757 charlotte.bjernved.nielsen.01@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04760132
Other Study ID Numbers  ICMJE ENFORCE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jens D Lundgren, MD, Rigshospitalet, Denmark
Study Sponsor  ICMJE Jens D Lundgren, MD
Collaborators  ICMJE Ministry of the Interior and Health, Denmark
Investigators  ICMJE
Study Chair: Jens Lundgren, Professor Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP