Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years

Sponsor
Tor Biering-Sørensen
Study ID
NCT07790523
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • mCombriax® (mRNA-1083) — BIOLOGICAL
    An authorized mRNA-based multicomponent vaccine encoding antigens targeting both seasonal influenza and SARS-CoV-2 viruses.
  • Efluelda® (TIV-HD) and Spikevax® (mRNA-1273) — BIOLOGICAL
    Same-day co-administration of an authorized high-dose trivalent influenza vaccine (TIV-HD; Efluelda®) and an authorized COVID-19 mRNA vaccine (Spikevax®, mRNA-1273)

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
410,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: mCombriax® (mRNA-1083)
    An authorized mRNA-based multicomponent vaccine encoding antigens targeting both seasonal influenza and SARS-CoV-2 viruses.
  • Active Comparator: Efluelda® (TIV-HD) and Spikevax® (mRNA-1273)
    Same-day co-administration of an authorized high-dose trivalent influenza vaccine (TIV-HD; Efluelda®) and an authorized COVID-19 mRNA vaccine (Spikevax®, mRNA-1273)

Primary Outcome Measure

Medically attended influenza and/or COVID-19 [ Time Frame: From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination ]

Central Contacts

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