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
← catalyst calendarSponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Double · Prevention
Enrollment
2,457actual
Sites
44
Countries
Japan, South Korea, Taiwan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-11-18 | actual | When the study began enrolling |
| Primary completion | 2025-11-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-17 | actual | The whole study's end, after follow-up |
| First posted | 2024-11-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- COVID-19
- Influenza
Interventions
- Biological: mRNA-1083
- Other: Placebo
- Biological: Licensed Influenza Vaccine — also filed as Influenza HA, Biken, and, Fluarix tetra
- Biological: SARS-CoV-2 Vaccine — also filed as mRNA-1273
Primary outcomes
what the primary-completion date above is the date OFGeometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay
measured Day 29
GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)
measured Day 29
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
measured Day 1 through 7 days after study injection
Number of Participants With Unsolicited Adverse Events (AEs)
measured Day 1 through 28 days after study injection
Number of Participants With Medically Attended Adverse Events (MAAEs)
measured Day 1 though Day 181
Number of Participants With Adverse Events of Special Interest (AESIs)
measured Day 1 though Day 181
Number of Participants With Serious Adverse Events (SAEs)
measured Day 1 through Day 181
Number of Participants With AEs Leading to Discontinuation
measured Day 1 through Day 181
Publications
- PMID 42531981 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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