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

Phase 4Not Yet RecruitingNCT07790523

Tor Biering-Sørensen410,000 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

410,000

Conditions

COVID-19 Influenza

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)

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, Denmark

Danske Lægers Vaccinations Service

Søborg, Denmark

General Public Health Directorate of Galician Health Service

Santiago de Compostela, A Coruña, Spain

Outcomes

Primary Outcomes

Medically attended influenza and/or COVID-19

Defined as a laboratory-confirmed positive influenza A/B test or positive SARS-CoV-2 test, regardless of healthcare setting, or influenza-related or COVID-19-related hospitalization, defined by ICD-10 codes.