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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06602531 | Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults | PHASE1 | COMPLETED | 212 | — | — | Dec 10, 2024 | Dec 5, 2025 | Apr 3, 2026 | 4 | United States |
Solicited local AEs including injection site pain, erythema, and swelling
Solicited systemic AEs including fatigue, headache, myalgia, arthralgia, nausea, dizziness, chills, and fever
Spontaneously reported adverse events and as elicited by investigational site staff
Abnormal clinically significant values
Spontaneously reported adverse events and as elicited by investigational site staff
HAI antibody levels expressed as GMT, GMFRs, SCRs, and HAI titers
ELLA antibody levels expressed as GMT, GMFRs, SCRs, and HAI titers
| Arm | Type | Description |
|---|---|---|
| Low dose of ARCT-2304, Schedule 1, Young Adults | EXPERIMENTAL | Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| Mid dose of ARCT-2304, Schedule 1, Young Adults | EXPERIMENTAL | Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| High dose of ARCT-2304, Schedule 1, Young Adults | EXPERIMENTAL | High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| Control, Schedule 1, Young Adults | ACTIVE_COMPARATOR | Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: Comparator vaccine younger adult and saline placebo vaccine |
| Low dose of ARCT-2304, Schedule 1, Older Adults | EXPERIMENTAL | Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| Mid dose of ARCT-2304, Schedule 1, Older Adults | EXPERIMENTAL | Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| High dose of ARCT-2304, Schedule 1, Older Adults | EXPERIMENTAL | High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304 |
| Control, Schedule 1, Older Adults | ACTIVE_COMPARATOR | Older Adults Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: Comparator vaccine older adult and saline |
| Low dose of ARCT-2304, Schedule 2, Young Adults | EXPERIMENTAL | Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| Mid dose of ARCT-2304, Schedule 2, Young Adults | EXPERIMENTAL | Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| High dose of ARCT-2304, Schedule 2, Young Adults | EXPERIMENTAL | High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| Control, Schedule 2, Young Adults | ACTIVE_COMPARATOR | Young Adults Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: Comparator vaccine younger adult and saline placebo vaccine |
| Low dose of ARCT-2304, Schedule 2, Older Adults | EXPERIMENTAL | Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| Mid dose of ARCT-2304, Schedule 2, Older Adults | EXPERIMENTAL | Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| High dose of ARCT-2304, Schedule 2, Older Adults | EXPERIMENTAL | High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304 |
| Control, Schedule 2, Older Adults | ACTIVE_COMPARATOR | Older Adults Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle. Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: Comparator vaccine older adult and saline placebo vaccine |
| Name | Type | Description |
|---|---|---|
| ARCT-2304 | BIOLOGICAL | Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle. |
| Control vaccine (licensed seasonal influenza vaccine) younger adults | BIOLOGICAL | Each participant will receive one intramuscular (IM) dose into the deltoid muscle. |
| Control vaccine (licensed seasonal influenza vaccine) older adults | BIOLOGICAL | Each participant will receive one intramuscular (IM) dose into the deltoid muscle. |
| Placebo Vaccine | OTHER | Each participant will receive one intramuscular (IM) dose into the deltoid muscle. |
Main Inclusion Criteria: * Individuals are male or female adults 18-80 years of age. * Healthy participants or participants with pre-existing stable medical conditions. * Individuals of childbearing potential must be willing to adhere to contraceptive requirements. Main Exclusion Criteria: * Indi...