A Phase 4 interventional study of COMIRNATY - BioNTech Manufacturing GmbH and COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH in SARS-CoV Infection, sponsored by Jens D Lundgren, MD. Completed at 5 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Jens D Lundgren, MD · Phase 4, Interventional, and Other
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).
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 7,600 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Jens D Lundgren, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
COMIRNATY (COVID-19, mRNA Vaccine) by BioNTech Manufacturing GmbH Marketing Authorisation EU/1/20/1528
Biological: COMIRNATY - BioNTech Manufacturing GmbH
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
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
Vaccination as part of the the Danish national government programme
Vaccination as part of the the Danish national government programme
Vaccination as part of the the Danish national government programme
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.
Time frame: The change from Base-line in MPNAT measured via profiling of antibodies against SARS-CoV-2 Spike epitopes at 24 month
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.
Time frame: The change from first vaccination until 24 month
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
Time frame: From first vaccine until Day 90
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
Time frame: From first vaccine until Day 90
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Jens D Lundgren, MD