COVID-19, Influenza
Conditions
Keywords
COVID-19, Influenza, mCombriax, Pragmatic, Registry, Respiratory tract disease, Cardiovascular, Hospitalization, Vaccination
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.
Interventions
BIOLOGICALmCombriax® (mRNA-1083)
An authorized mRNA-based multicomponent vaccine encoding antigens targeting both seasonal influenza and SARS-CoV-2 viruses.
BIOLOGICALEfluelda® (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)
Sponsors
Tor Biering-Sørensen
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medically attended influenza and/or COVID-19 | From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination | 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. |
| Influenza and/or COVID-19 hospitalization | From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination | Defined as hospitalization with a relevant ICD-10 code for influenza or COVID-19 infection or any hospitalization with a laboratory-confirmed positive influenza A/B test or SARS-CoV-2 test performed within 7 days prior to hospitalization or within 48 hours of hospital admission. |
Secondary
| Measure | Time frame |
|---|---|
| Medically attended influenza | From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination |
| Influenza hospitalization | From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination |
| Medically attended COVID-19 | From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination |
| COVID-19 hospitalization | From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination |
| All-cause cardio-respiratory hospitalization | From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination |
| All-cause respiratory tract disease hospitalization | From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination |
| All-cause hospitalization | From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination |
Countries
Denmark, Spain
Contacts
CONTACTLisa S Duus
CONTACTTor Biering-Sørensen
STUDY_CHAIRTor Biering-Sørensen
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Outcome results
None listed