A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
← catalyst calendarSponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
1,320actual
Sites
17
Country
United States
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 | 2025-03-07 | actual | When the study began enrolling |
| Primary completion | 2025-10-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-13 | actual | The whole study's end, after follow-up |
| First posted | 2025-03-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Influenza
- SARS-CoV-2
Interventions
- Biological: mRNA-1083 Composition 1 Dose A Lot A
- Biological: mRNA-1083 Composition 1 Dose A Lot B
- Biological: mRNA-1083 Composition 1 Dose B
- Biological: mRNA-1083 Composition 1 Dose C
- Biological: mRNA-1083 Composition 2 Dose A
- Biological: mRNA-1083 Composition 2 Dose B
- Biological: mRNA-1083 Composition 3 Dose A
- Biological: mRNA-1083 Composition 3 Dose B
- Biological: Influenza Vaccine
- Biological: COVID-19 Vaccine
- Biological: Investigational Influenza Vaccine
- Biological: Investigational COVID-19 Vaccine Lot A
- Biological: Investigational COVID-19 Vaccine Lot B
Primary outcomes
what the primary-completion date above is the date OFGeometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza
measured Day 29
Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
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), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation From the Study
measured Day 1 through Day 181
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