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

NCT04760132 | Completed Phase 4

• 1 other identifier: ENFORCE
• Study Type: interventional
• Target: 7,600
• Locations: 1 country
• Sites: 5

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).

Conditions

SARS-CoV Infection

Keywords

COVID-19; Vaccination

Outcome Measures

Primary Outcomes (1)

• Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines

  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 Outcomes (3)

• Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines

  The change from first vaccination until 24 month

• Assessment of the safety of the vaccines will be compared between groups

  From first vaccine until Day 90

• Assessment of any Adverse Event from the vaccines will be compared between groups

  From first vaccine until Day 90

Study Arms (3)

Vaccine A - COMIRNATY COVID-19 vaccine

ACTIVE COMPARATOR

COMIRNATY (COVID-19, mRNA Vaccine) by BioNTech Manufacturing GmbH Marketing Authorisation EU/1/20/1528

Biological: COMIRNATY - BioNTech Manufacturing GmbH

Vaccine B - Moderna COVID-19 vaccine

ACTIVE COMPARATOR

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

Vaccine C - Astra-Zeneca COVID-19 vaccine

ACTIVE COMPARATOR

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

Interventions

COMIRNATY - BioNTech Manufacturing GmbH BIOLOGICAL

Vaccination as part of the the Danish national government programme

Vaccine A - COMIRNATY COVID-19 vaccine

COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH BIOLOGICAL

Vaccination as part of the the Danish national government programme

Vaccine B - Moderna COVID-19 vaccine

COVID-19 Vaccine AstraZeneca suspension for injection BIOLOGICAL

Vaccination as part of the the Danish national government programme

Vaccine C - Astra-Zeneca COVID-19 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Jens D Lundgren, MD: lead
• Ministry of the Interior and Health, Denmark: collaborator

Study Sites (5)

Aarhus Universitetshospital, Skejby

Aarhus, Aarhus N, 8200, Denmark

Location

Aalborg Universityhospital Syd

Aalborg, 9000, Denmark

Location

Hvidovre Hospital

Hvidovre, 2600, Denmark

Location

Odense Universityhospital

Odense, 5000, Denmark

Location

Sjællandsuniversitetshospital

Roskilde, 4000, Denmark

Location

Related Publications (1)

• Staerke NB, Reekie J, Johansen IS, Nielsen H, Benfield T, Wiese L, Sogaard OS, Tolstrup M, Iversen KK, Tarp B, Larsen FD, Larsen L, Lindvig SO, Holden IK, Iversen MB, Knudsen LS, Fogh K, Jakobsen ML, Traytel AK, Ostergaard L, Lundgren J; ENFORCE Study Group. Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE). BMJ Open. 2022 Dec 30;12(12):e069065. doi: 10.1136/bmjopen-2022-069065.

  PMID: 36585137 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Interventions

Injections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jens Lundgren, Professor

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 18, 2021
• Study Start: February 8, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)