Clinical trial NCT04760132: National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)
Official title: National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: SARS-CoV Infection
Keywords: COVID-19
Vaccination
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Ministry of the Interior and Health, Denmark
First posted: 2021-02-18
Enrollment: 7600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
Primary purpose: OTHER

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).

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines
timeFrame: The change from Base-line in MPNAT measured via profiling of antibodies against SARS-CoV-2 Spike epitopes at 24 month
Secondary outcomes:
measure: Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines
timeFrame: The change from first vaccination until 24 month
measure: Assessment of the safety of the vaccines will be compared between groups
timeFrame: From first vaccine until Day 90
measure: Assessment of any Adverse Event from the vaccines will be compared between groups
timeFrame: From first vaccine until Day 90
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Aarhus N
city: Aalborg
country: Denmark
facility: Aalborg Universityhospital Syd
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense Universityhospital
city: Roskilde
country: Denmark
facility: Sjællandsuniversitetshospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jens Lundgren, Professor
role: STUDY_CHAIR
References: