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

Jens D Lundgren, MD

Status and phase: Completed; Phase 4

Conditions: SARS-CoV Infection

Treatments: Biological: COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH; Biological: COVID-19 Vaccine AstraZeneca suspension for injection; Biological: COMIRNATY - BioNTech Manufacturing GmbH

Study type: Interventional

Funder types: Other

Identifiers

NCT04760132

ENFORCE

Details and patient eligibility

About

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).

Full 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

Enrollment: 7,600 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

7,600 participants in 3 patient groups

Vaccine A - COMIRNATY COVID-19 vaccine

Active Comparator group

Description:

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

Treatment:

Biological: COMIRNATY - BioNTech Manufacturing GmbH

Vaccine B - Moderna COVID-19 vaccine

Active Comparator group

Description:

COVID-19 Vaccine Moderna dispersion for injection (COVID-19, mRNA Vaccine) by MODERNA BIOTECH SPAIN S.L. Marketing Authorisation EU/1/20/1507/001

Treatment:

Biological: COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH

Vaccine C - Astra-Zeneca COVID-19 vaccine

Active Comparator group

Description:

COVID-19 Vaccine AstraZeneca suspension for injection (ChAdOx1-S \[recombinant\]) by AstraZeneca AB Marketing Authorisation EU/1/21/1529/001 and /002

Treatment:

Biological: COVID-19 Vaccine AstraZeneca suspension for injection