A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults
← catalyst calendarSponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · None · Prevention
Enrollment
172actual
Sites
1
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 | 2022-11-02 | actual | When the study began enrolling |
| Primary completion | 2025-11-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-13 | actual | The whole study's end, after follow-up |
| First posted | 2022-11-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Influenza
Interventions
- Biological: mRNA-1010
- Biological: Egg-based Quadrivalent Influenza Vaccine — also filed as Fluarix®
- Biological: Adjuvanted Quadrivalent Influenza Vaccine — also filed as Fluad®
- Biological: Inactivated Influenza Vaccine — also filed as Fluzone®
- Biological: mRNA-1345
- Biological: mRNA-1045
Primary outcomes
what the primary-completion date above is the date OFParts A, B, and C: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
measured Up to Day 7 (7 days after vaccination)
Parts A, B, and C: Number of Unsolicited Adverse Events (AEs)
measured Up to Day 28 (28 days after vaccination)
Parts A, B, and C: Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
measured Day 1 through Day 181
Parts A, B, and C: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay
measured Day 29
Part C: GMT of Anti-Respiratory Syncytial Virus (RSV) Antibodies at Day 29, as Measured by Microneutralization Assay for RSV A and B
measured Day 29
Parts A, B, and C: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
measured Baseline, Day 29
Part C: GMFR of Anti-RSV Antibodies at Day 29, as Measured by Microneutralization Assay
measured Baseline, Day 29
Parts A, B, and C: Percentage of Participants with Seroresponse at Day 29, as Measured by HAI Assay
measured Day 29
Part C: Percentage of Participants with Seroresponse at Day 29, as Measured by RSV Neutralization Assay
measured Day 29
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