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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05972174 | A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults | PHASE1 | COMPLETED | 1,504 | — | — | Jul 10, 2023 | Jul 16, 2024 | Jul 16, 2025 | 27 | United States, United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1 | EXPERIMENTAL | Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2 | EXPERIMENTAL | Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3 | EXPERIMENTAL | Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1 | EXPERIMENTAL | Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2 | EXPERIMENTAL | Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22. |
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3 | EXPERIMENTAL | Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1 | EXPERIMENTAL | Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2 | EXPERIMENTAL | Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3 | EXPERIMENTAL | Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1 | EXPERIMENTAL | Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2 | EXPERIMENTAL | Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22. |
| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3 | EXPERIMENTAL | Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22. |
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1 | EXPERIMENTAL | Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22. |
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2 | EXPERIMENTAL | Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22. |
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3 | EXPERIMENTAL | Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22. |
| Name | Type | Description |
|---|---|---|
| mRNA-1018 for H5N8 | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1018 for H7N9 | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1018 for H5 Only | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1018 for H7 Only | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1018 for H5 Only-CG | BIOLOGICAL | Sterile liquid for injection |
Key Inclusion Criteria: * Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and results of electrocardiogram testing. * Body mass index of 18 kilograms (kg)/square meter (m\^2) to 39 kg/m\^2 (inclusive) at the Screening visit. * For femal...