A Phase 4 Pragmatic, Randomized Trial to Evaluate the Effectiveness and Safety of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19 (DAN-COVID)

2025-523841-82-00 Protocol DAN-COVID Therapeutic use (Phase IV) Ongoing, recruitment ended

Start 11 Dec 2025 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 2 sites · Protocol DAN-COVID

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruitment ended
Participants planned 275,000
Countries 1
Sites 2

SARS-CoV-2 infection

The primary objective of the study is to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of medically attended COVID-19 infection compared to no vaccine in adults aged 50-64 years, free from risk factors for severe COVID-19 disease.

Key facts

Sponsor
Gentofte Hospital, Moderna Inc.
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Virus Diseases [C02]
Trial duration
11 Dec 2025 → ongoing
Decision date (initial)
2025-11-26
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Moderna

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis, Safety

The primary objective of the study is to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of medically attended COVID-19 infection compared to no vaccine in adults aged 50-64 years, free from risk factors for severe COVID-19 disease.

Secondary objectives 9

  1. to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of the following endpoint: COVID-19-related hospitalization
  2. to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of the following endpoint: COVID-19-related respiratory tract disease hospitalization
  3. to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of the following endpoint: 3. COVID-19-related cardio-respiratory disease hospitalization
  4. to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of the following endpoint: 4. All-cause respiratory tract infection hospitalization
  5. to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of the following endpoint: 5. All-cause cardio-respiratory hospitalization
  6. to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of the following endpoint: 6. All-cause lower respiratory tract disease hospitalization
  7. to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of the following endpoint: 7. All-cause hospitalization
  8. to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of the following endpoint: COVID-19 death
  9. to evaluate the vaccine effectiveness of mRNA-1273 in reducing the risk of the following endpoint: All-cause death

Conditions and MedDRA coding

SARS-CoV-2 infection

VersionLevelCodeTermSystem organ class
28.0 LLT 10086479 SARS-CoV-2 variant infection 100000004848

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Age 50-64 years
  2. Informed consent form has been signed and dated

Exclusion criteria 1

  1. The trial has no formal exclusion criteria

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Medically attended COVID-19, defined as a positive PCR test for SARS-CoV-2 or hospitalization for COVID-19-related respiratory tract disease. The prespecified registry-based definition of the primary endpoint is as follows: Medically attended COVID-19 (ICD-10 codes: B342, B972, U071) diagnosis type: A. Requires either a positive SARS-CoV-2 PCR test from the Danish Microbiology Database OR COVID-19-related hospitalization

Secondary endpoints 9

  1. 1. COVID-19-related hospitalization
  2. 2. COVID-19-related respiratory tract disease hospitalization
  3. 3. COVID-19-related cardio-respiratory disease hospitalization
  4. 4. All-cause respiratory tract infection hospitalization
  5. 5. All-cause cardio-respiratory hospitalization
  6. 6. All-cause lower respiratory tract disease hospitalization
  7. 7. All-cause hospitalization
  8. 8. COVID-19 death
  9. 9. All-cause death

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Spikevax 50 micrograms dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine

PRD10000341 · Product

Active substance
Elasomeran
Substance synonyms
mRNA-1273, CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), CX-024414, COVID-19 mRNA vaccine Moderna (CX-024414)
Pharmaceutical form
DISPERSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07BN01 — -
Marketing authorisation
EU/1/20/1507/003
MA holder
MODERNA BIOTECH SPAIN S. L.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gentofte Hospital

22 Total trials 10 Recruiting 9 Ended
Commercial
Sponsor organisation
Gentofte Hospital
Address
Gentofte Hospitalsvej 1
City
Hellerup
Postcode
2900
Country
Denmark

Scientific contact point

Organisation
Gentofte Hospital
Contact name
Tor Biering-Sørensen

Public contact point

Organisation
Gentofte Hospital
Contact name
Sine Hoejlund Christensen

Third parties 1

OrganisationCity, countryDuties
GCP-enheden ved Københavns Universitetshospital
ORL-000007465
 Frederiksberg, Denmark On site monitoring

Moderna Inc.

9 Total trials 2 Recruiting 6 Ended
Commercial
Sponsor organisation
Moderna Inc.
Address
325 Binney Street
City
Cambridge
Postcode
02142-1038
Country
United States

Sponsor responsibilities

Article 77 compliance
Gentofte Hospital
Contact point sponsor
Gentofte Hospital
Article 77 implementation
Gentofte Hospital

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruitment ended 275,000 2
Rest of world — 0 —

Investigational sites

Denmark

2 sites · Ongoing, recruitment ended
Danske Lægers Vaccinations Service
Danske Lægers vaccinations Service, Gladsaxevej 376. 1., 2860, Søborg
Gentofte Hospital
Center for translational Cardiology and Pragmatic Randomized Trials, Gentofte Hospitalsvej 1, 2900, Hellerup

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2025-12-11 2025-12-11 2026-02-27

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) DAN-COVID protocol EU CT 2025-523841-82-00 1.3
Protocol (for publication) DAN-COVID protocol final_tracked 1.3
Protocol (for publication) DAN-COVID_EQ-5D-5L Danish 1
Recruitment arrangements (for publication) K1_DAN-COVID Invitation letter 1.3
Recruitment arrangements (for publication) K1_DAN-COVID Invitation letter_tracked 1.3
Recruitment arrangements (for publication) K1_DAN-COVID_Video-transcript 1.3
Recruitment arrangements (for publication) K1_DAN-COVID_Video-transcript_ENGLISH 1.2
Recruitment arrangements (for publication) K1_DAN-COVID_Video-transcript_ENGLISH_tracked 1.2
Recruitment arrangements (for publication) K1_DAN-COVID_Video-transcript_tracked 1.3
Recruitment arrangements (for publication) K1_DAN-COVID_Website-advertisement 1.3
Recruitment arrangements (for publication) K1_DAN-COVID_Website-advertisement_tracked 1.3
Recruitment arrangements (for publication) K1_recruitment arrangement 1.2
Recruitment arrangements (for publication) K1_recruitment arrangement_tracked 1.2
Subject information and informed consent form (for publication) L1_DAN-COVID_Deltagerinformation 1.3
Subject information and informed consent form (for publication) L1_DAN-COVID_Deltagerinformation_ENGLISH 1.2
Subject information and informed consent form (for publication) L1_DAN-COVID_Deltagerinformation_ENGLISH_tracked 1.2
Subject information and informed consent form (for publication) L1_DAN-COVID_Deltagerinformation_tracked 1.3
Subject information and informed consent form (for publication) L1_Samtykkeerklring 1.1
Subject information and informed consent form (for publication) L1_Samtykkeerklring_ENGLISH 1.0
Subject information and informed consent form (for publication) L1_Samtykkeerklring_tracked 1.1
Summary of Product Characteristics (SmPC) (for publication) SmPC_Spikewax 1.0
Synopsis of the protocol (for publication) D1_DAN-COVID Protocol-synopsis 1.2
Synopsis of the protocol (for publication) D1_DAN-COVID Protocol-synopsis_tracked 1.2

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-09-29 Denmark Acceptable
2025-11-26
 2025-11-26

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