drugset / Trial / NCT05581407
Safety, Tolerability, and Immunogenicity of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccin
RandomizedParallel-groupQuadruple-blindPrevention
Summary
There is an obvious need for an affordable and more effective seasonal influenza vaccine. TETRALITE is a novel, inactivated, adjuvanted influenza vaccine combining a low dose of a licensed vaccine with the novel, potent LiteVax Adjuvant. A licensed vaccine (Cohort 1) with a normal dose \[15 ug per strain\] and no adjuvant will be compared with two TETRALITE study vaccines with 1/5th of the licensed vaccine added with a low (Cohort 2) or high (Cohort 3) dose of LiteVax Adjuvant.
Timeline
- Start
- 2022-10-03
- Primary completion
- 2023-08-03
- Completion
- 2023-10-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NITRAMINE | Vaccine | 15 ug | — |
| Subject | NITRAMINE | Vaccine | 1 mg | — |
| Subject | NITRAMINE | Vaccine | 4 mg | — |