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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    10000
  • sponsor
    Jens D Lundgren, MD
Updated on 7 March 2021

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).

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

Details
Condition Severe Acute Respiratory Syndrome
Treatment COMIRNATY - BioNTech Manufacturing GmbH, COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH, COVID-19 Vaccine AstraZeneca suspension for injection
Clinical Study IdentifierNCT04760132
SponsorJens D Lundgren, MD
Last Modified on7 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

Male and female under the age of 18
Any subgroup of individuals for which the vaccines are contraindicated
Previous SARS-CoV-2 vaccination
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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