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

ConditionsCOVID-19Influenza
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorTor Biering-Sørensen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥65 years at the time of vaccination

Self-reported ability to understand written and spoken English or Danish (Denmark only) or Spanish or Galician (Spain only)

Informed consent form has been signed and dated

Disqualifiers

There are no specific exclusion criteria for this study

Trial design

Design model

Parallel

Treatments tested in this trial

  • mCombriax® (mRNA-1083)

    Biological/Vaccine

    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/Vaccine

    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)

Treatment groups

410,000 Participants
are divided into 2 treatment groups
Group A: mCombriax® (mRNA-1083)Experimental treatment 1 intervention
Group B: Efluelda® (TIV-HD) and Spikevax® (mRNA-1273)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
2

Influenza and/or COVID-19 hospitalization

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.

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination

Secondary outcomes

1

Medically attended influenza

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
2

Influenza hospitalization

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
3

Medically attended COVID-19

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
4

COVID-19 hospitalization

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination

Other outcomes

1

Influenza-related cardio-respiratory hospitalization

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
2

COVID-19-related cardio-respiratory hospitalization

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
3

Influenza-related respiratory tract disease hospitalization

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
4

COVID-19-related respiratory tract disease hospitalization

Time frame
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution

ModernaTX, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: