Phase 2
N=1,758
A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
SARS-CoV-2 · Influenza
Bottom Line
View on ClinicalTrials.gov: NCT05827926 ↗Enrolled (actual)
1,758
Serious AEs
1.8%
Results posted
Dec 2025
Primary outcome: Primary: Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) — 32; 36; 37; 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Influenza Vaccine 1 (Biological); mRNA-1083.1 (Biological); mRNA-1083.2 (Biological); mRNA-1083.3 (Biological); Investigational Influenza Vaccine 1 (Biological); Investigational COVID-19 Vaccine 1 (Biological); COVID-19 Vaccine 1 (Biological); Investigational Influenza Vaccine 2 (Biological); Influenza Vaccine 2 (Biological); mRNA-1083 (Biological); Investigational COVID-19 Vaccine 2 (Biological); COVID-19 Vaccine 2 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ModernaTX, Inc.
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) |
32; 36; 37; 43; 42; 31 | — |
| PRIMARY Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs |
5; 9; 7; 5; 7; 9 | — |
| PRIMARY Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation |
2; 2; 1; 1; 2; 1 | — |
| PRIMARY Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay |
80.0; 105.1; 129.0; 73.9; 98.3; 111.2 | — |
| PRIMARY Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) |
1567.0; 1939.7; 427.6; 901.0; 882.0; 1108.3 | — |
| PRIMARY Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay |
2.6; 3.5; 3.7; 1.8; 2.2; 2.7 | — |
| PRIMARY Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA |
5.4; 9.1; 3.3; 5.4; 4.4; 3.6 | — |
| PRIMARY Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay |
45.5; 50.0; 36.4; 22.2; 23.5; 36.1 | — |
| PRIMARY Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA |
40.5; 43.3; 36.1; 32.4; 37.1; 25.0 | — |
| SECONDARY Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay |
49.7; 47.5; 55.0; 55.7; 58.2; 41.4 | — |
| SECONDARY Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA |
618.0; 574.1; 616.9; 585.9; 646.6; 536.3 | — |
| SECONDARY Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay |
1.6; 1.8; 2.0; 2.7; 1.6; 2.5 | — |
| SECONDARY Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA |
7.3; 10.0; 7.5; 9.6; 5.7; 6.8 | — |
| SECONDARY Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay |
11.8; 14.0; 18.4; 28.9; 12.0; 33.3 | — |
| SECONDARY Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA |
62.7; 69.4; 68.0; 75.9; 56.9; 62.7 | — |
| SECONDARY Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay |
30.4; 30.1; 35.1; 41.8; 44.9; 40.6 | — |
| SECONDARY Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA |
292.2; 214.1; 128.8; 168.1; 198.5; 307.8 | — |
| SECONDARY Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay |
2.9; 3.2; 3.1; 2.3; 2.1; 2.9 | — |
| SECONDARY Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA |
3.3; 4.5; 2.8; 3.7; 3.4; 2.3 | — |
| SECONDARY Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay |
45.5; 50.0; 36.4; 22.2; 23.5; 36.1 | — |
| SECONDARY Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA |
40.5; 43.3; 36.1; 32.4; 37.1; 25.0 | — |
Summary
The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults.
The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and <50 years of age.
Eligibility Criteria
Key Inclusion Criteria
Part 1 (Phase 1/2)
- Adults ≥18 to 14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
- Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration.
- Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1.
- Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
- Participant 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.
- Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the clinical trial.
- Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home.
Part 2 (Phase 2 Extension) Only
- Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study.
Note: Other inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05827926). 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.