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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06125691 | Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults | PHASE1 | COMPLETED | 139 | — | — | Jan 22, 2024 | Jan 7, 2025 | Oct 3, 2025 | 2 | Australia |
Solicited local AEs include injection-site pain, erythema and swelling
Solicited systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, 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, GMFI, SCRs and HAI titers.
ELLA antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 of ARCT-2138, younger adults | EXPERIMENTAL | Dose Level 1 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Cohort 2 of ARCT-2138, younger adults | EXPERIMENTAL | Dose Level 2 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Cohort 3 of ARCT-2138, younger adults | EXPERIMENTAL | Dose Level 3 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Cohort 4 of ARCT-2138, younger adults | EXPERIMENTAL | Dose Level 4 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Low Dose, younger and older adults | EXPERIMENTAL | Low dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Medium Dose, younger and older adults | EXPERIMENTAL | Medium dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| High Dose, younger and older adults | EXPERIMENTAL | High dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Control Dose, younger adults | ACTIVE_COMPARATOR | Licensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle. Interventions: Control Vaccine: Licensed Quadrivalent Vaccine for younger adults |
| Control Dose, older adults | ACTIVE_COMPARATOR | Licensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle. Interventions: Control Vaccine: Licensed Quadrivalent Vaccine for older adults |
| Name | Type | Description |
|---|---|---|
| ARCT-2138 | BIOLOGICAL | Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle. |
| Licensed Quadrivalent Vaccine for younger adults | BIOLOGICAL | Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle. |
| Licensed Quadrivalent Vaccine for older adults | BIOLOGICAL | Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle. |
Inclusion Criteria: 1. Individuals are male, female, or transgender adults 18 to 49 years of age or 65 to 85 years of age. 2. Healthy participants or participants with pre-existing stable medical conditions. Pre-existing stable medical condition means a subject who: has full capacity of daily activ...