Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06864143 | 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 | PHASE2 | COMPLETED | 1,320 | — | — | Mar 7, 2025 | Oct 13, 2025 | Oct 20, 2025 | 17 | United States |
| Arm | Type | Description |
|---|---|---|
| mRNA-1083 Composition 1 Dose A Lot A | EXPERIMENTAL | Participants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1. |
| mRNA-1083 Composition 1 Dose A Lot B | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1. |
| mRNA-1083 Composition 1 Dose B | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1. |
| mRNA-1083 Composition 1 Dose C | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1. |
| mRNA-1083 Composition 2 Dose A | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1. |
| mRNA-1083 Composition 2 Dose B | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1. |
| mRNA-1083 Composition 3 Dose A | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1. |
| mRNA-1083 Composition 3 Dose B | EXPERIMENTAL | Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1. |
| Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive single IM injection of Influenza Vaccine on Day 1. |
| COVID-19 Vaccine | ACTIVE_COMPARATOR | Participants will receive single IM injection of COVID-19 Vaccine on Day 1. |
| Investigational Influenza Vaccine | ACTIVE_COMPARATOR | Participants will receive single IM injection of Investigational Influenza Vaccine on Day 1. |
| Investigational COVID-19 Vaccine Lot A | ACTIVE_COMPARATOR | Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1. |
| Investigational COVID-19 Vaccine Lot B | ACTIVE_COMPARATOR | Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1. |
| Name | Type | Description |
|---|---|---|
| mRNA-1083 Composition 1 Dose A Lot A | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1083 Composition 1 Dose A Lot B | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1083 Composition 1 Dose B | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1083 Composition 1 Dose C | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1083 Composition 2 Dose A | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1083 Composition 2 Dose B | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1083 Composition 3 Dose A | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1083 Composition 3 Dose B | BIOLOGICAL | Sterile liquid for injection |
| Influenza Vaccine | BIOLOGICAL | Sterile liquid for injection |
| COVID-19 Vaccine | BIOLOGICAL | Sterile liquid for injection |
| Investigational Influenza Vaccine | BIOLOGICAL | Sterile liquid for injection |
| Investigational COVID-19 Vaccine Lot A | BIOLOGICAL | Sterile liquid for injection |
| Investigational COVID-19 Vaccine Lot B | BIOLOGICAL | Sterile liquid for injection |
Inclusion Criteria: * Medically stable. * Participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to Day 1 and for at least 90 days after the study intervention administration. * Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with...