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NCT Number: NCT04760132

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

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).

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Key information

Conditions

SARS-CoV Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus Universitetshospital, Skejby, Aarhus, Aarhus N, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COMIRNATY - BioNTech Manufacturing GmbH

Biological

Vaccination as part of the the Danish national government programme

COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH

Biological

Vaccination as part of the the Danish national government programme

COVID-19 Vaccine AstraZeneca suspension for injection

Biological

Vaccination as part of the the Danish national government programme

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Jens D Lundgren, MD

Other

Collaborators

  • Ministry of the Interior and Health, Denmark

Registry information

Official study title

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

Acronym: ENFORCE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2021
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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