drugset / Trial / NCT06125691
Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults
Phase 1
Completed
139 enrolled
Arcturus Therapeutics, Inc.
Novotech (Australia) Pty Limited · collabSeqirus · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.
Timeline
- Start
- 2024-01-22
- Primary completion
- 2024-08-10
- Completion
- 2025-01-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARCT-2138 | Small activating RNA (saRNA) | 0.5 ml | Intramuscular |
| Comparator | Fluad® Quad | Unknown | 0.5 ml | Intramuscular |
| Comparator | Flucelvax Quad | Vaccine | 0.5 ml | Intramuscular |