drugset / Trial / NCT06560151
Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59
Phase 2
Completed
1380 enrolled
Biomedical Advanced Research and Development Authority
ICON plc · collabRho Federal Systems Division, Inc. · collab
RandomizedParallel-groupQuadruple-blindOther
Summary
This BARDA-sponsored, randomized, double-blind, phase 2 study is designed to assess safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59.
Timeline
- Start
- 2024-08-21
- Primary completion
- 2025-01-02
- Completion
- 2025-06-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AS03A | Unknown | — | Intramuscular |
| Subject | H5N1 Antigen | Vaccine | 3.75 ug | Intramuscular |
| Subject | H5N1 Antigen | Vaccine | 7.5 ug | Intramuscular |
| Subject | H5N1 Antigen | Vaccine | 15 ug | Intramuscular |
| Subject | H5N8 antigen | Vaccine | 3.75 ug | Intramuscular |
| Subject | H5N8 antigen | Vaccine | 7.5 ug | Intramuscular |
| Subject | H5N8 antigen | Vaccine | 15 ug | Intramuscular |
| Subject | MF59 | Other / unclassified | — | Intramuscular |