A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine)
← catalyst calendarSponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Double · Prevention
Enrollment
932actual
Sites
17
Countries
Canada, 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 | 2024-07-15 | actual | When the study began enrolling |
| Primary completion | 2025-09-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-25 | actual | The whole study's end, after follow-up |
| First posted | 2024-07-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-14 | 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
Intervention
- Biological: mRNA-1083
Primary outcomes
what the primary-completion date above is the date OFGeometric Mean Value of Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay for Influenza
measured Day 29
Geometric Mean Value of Antibodies at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) for SARS-CoV-2
measured Day 29
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
measured Up to Day 7 (7 days after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
measured Up to Day 28 (28 days after vaccination)
Number of Participants with Medically Attended Adverse Events (MAAEs)
measured Up to Day 181
Number of Participants with Adverse Events of Special Interest (AESIs)
measured Up to Day 181
Number of Participants with Serious Adverse Events (SAEs)
measured Up to Day 181
Number of Participants with AEs Leading to Discontinuation from Study Participation
measured Up to Day 181
Permalink · MRNA's whole pipeline · Catalyst calendar · Every registered study · What changed