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

SARS-CoV Infection Clinical Trial

— ENFORCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04760132
• Other study ID #: ENFORCE
• Status: Completed
• Phase: Phase 4
• Start date: February 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7600
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• COMIRNATY - BioNTech Manufacturing GmbH
Vaccination as part of the the Danish national government programme
• COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH
Vaccination as part of the the Danish national government programme
• COVID-19 Vaccine AstraZeneca suspension for injection
Vaccination as part of the the Danish national government programme

Locations

Country	Name	City	State
Denmark	Aalborg Universityhospital Syd	Aalborg
Denmark	Aarhus Universitetshospital, Skejby	Aarhus	Aarhus N
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Odense Universityhospital	Odense
Denmark	Sjællandsuniversitetshospital	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Jens D Lundgren, MD	Ministry of the Interior and Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines	Number of confirmed positive SARS-CoV-2 tests reported via the national testing system.	The change from first vaccination until 24 month
Secondary	Assessment of the safety of the vaccines will be compared between groups	Reports of participants with local and systemic reactions to the vaccination will be collected	From first vaccine until Day 90
Secondary	Assessment of any Adverse Event from the vaccines will be compared between groups	Reports of participants with grade 3 and 4 Adverse Events and any Serious Adverse will be collected	From first vaccine until Day 90