• A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults

  NCT07464314

  RecruitingInterventionalPhase 1Updated Jun 30, 2026
• Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older

  NCT06695130

  CompletedInterventionalPhase 1Phase 2Updated May 5, 2026
• Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age

  NCT06694389

  CompletedInterventionalPhase 3Updated Dec 2, 2025
• Assessing Immune Response of Different COVID-19 Vaccines in Older Adults

  NCT05160766

  CompletedInterventionalPhase 2Updated May 20, 2025
• A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

  NCT06097273

  CompletedInterventionalPhase 3Updated Jul 1, 2025
• A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults

  NCT05091307

  CompletedInterventionalPhase 3Updated May 25, 2025

ClinicalTrials.gov ID

NCT07790523

Lead Sponsor

Tor Biering-SørensenOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

410,000Estimated

Last Update Posted

Aug 27, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

May 31, 2028Estimated

Completion Date

Sep 30, 2028Estimated

Official Title

A Phase 4, Pragmatic, Randomized Trial to Evaluate the Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years

Brief Summary

The purpose of this pragmatic randomized trials is to evaluate the comparative vaccine effectiveness (cVE) of mCombriax® (mRNA-1083) versus same day co-administration of the active comparators (i.e., high-dose influenza vaccine/Efluelda® and mRNA-1273/Spikevax®) among adults aged 65 years and older.

Detailed Description

This Phase 4 randomized, active-comparator, pragmatic trial is designed to evaluate the effectiveness of a seasonal variant-containing formulation of mCombriax® (mRNA-1083) compared with same-day co-administration of authorized standalone enhanced influenza and COVID-19 vaccines in adults aged ≥65 years. The trial is designed to be conducted over two consecutive respiratory virus seasons to account for potential seasonal variation in virus circulation, vaccine composition, and effectiveness. The primary objective is to evaluate the comparative vaccine effectiveness (cVE) of the combination vaccine with respect to clinically relevant outcomes, including severe influenza and COVID-19. Demonstration of non-inferior protection in real-world setting, in combination with the potential programmatic advantages of a single-dose strategy, may support policy recommendations, reimbursement decisions, and broader implementation of combined seasonal respiratory vaccination strategies.

• COVID-19
• Influenza

• mCombriax® (mRNA-1083)
• Efluelda® (TIV-HD) and Spikevax® (mRNA-1273)

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

1. Age ≥65 years at the time of vaccination
2. Self-reported ability to understand written and spoken English or Danish (Denmark only) or Spanish or Galician (Spain only)
3. Informed consent form has been signed and dated

Exclusion Criteria:

• There are no specific exclusion criteria for this study

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Tor Biering-SørensenOTHER

Collaborators

ModernaTX, Inc.INDUSTRY

carslars@rm.dk+4540459708