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

NCT04760132 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7600

Last updated 2024-04-12

No results posted yet for this study

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).

Conditions

  • SARS-CoV Infection

Interventions

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

Sponsors & Collaborators

  • Ministry of the Interior and Health, Denmark

    collaborator OTHER_GOV

  • Jens D Lundgren, MD

    lead OTHER

Principal Investigators

  • Jens Lundgren, Professor · Rigshospitalet, Denmark

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760132 on ClinicalTrials.gov