Phase 3
N=8,061
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
SARS-CoV-2 · Influenza
Bottom Line
View on ClinicalTrials.gov: NCT06097273 ↗Enrolled (actual)
8,061
Serious AEs
2.2%
Results posted
Jun 2025
Primary outcome: Primary: Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay — 120.5; 104.3; 137.7; 97.3 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mRNA-1083 (Biological); Placebo (Biological); Influenza Vaccine (Biological); COVID-19 Vaccine (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- ModernaTX, Inc.
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay |
120.5; 104.3; 137.7; 97.3; 114.7; 107.9 | — |
| PRIMARY GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) |
1396.7; 851.1; 1551.6; 1186.1 | — |
| PRIMARY Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay |
36.4; 31.1; 50.6; 32.7; 38.7; 34.6 | — |
| PRIMARY SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA |
82.3; 69.6; 84.6; 76.5 | — |
| PRIMARY Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) |
1681; 1565; 1698; 1640; 183; 84 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events (AEs) |
239; 250; 195; 191 | — |
| PRIMARY Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation |
70; 52; 29; 27; 18; 13 | — |
| SECONDARY Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay |
2.70; 2.36; 3.70; 2.54; 2.78; 2.59 | — |
| SECONDARY GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA |
16.86; 10.32; 17.83; 13.56 | — |
| SECONDARY GM Level of Antibodies for Influenza, as Measured by Microneutralization (MN) Assay |
676.4; 635.9; 946.8; 428.1; 587.6; 668.8 | — |
| SECONDARY GMFR of Antibodies for Influenza, as Measured by MN Assay |
4.89; 4.68; 8.74; 5.14; 2.88; 2.46 | — |
Summary
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to <65 years of age (Cohort B).
Eligibility Criteria
Key Inclusion Criteria
- Healthy adults either ≥65 years of age (Cohort A) or 50 to 14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.
- Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
- Received a seasonal influenza vaccine ≤150 days prior to Day 1.
- Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
- Has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
- Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT06097273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.