drugset / Trial / NCT05581407

Safety, Tolerability, and Immunogenicity of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccin

NCT05581407

Phase 1 Completed 60 enrolled LiteVax BV University Hospital, Ghent · collab
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

EvaluationDrugModalityDoseRoute
Subject NITRAMINE Vaccine 15 ug
Subject NITRAMINE Vaccine 1 mg
Subject NITRAMINE Vaccine 4 mg

Indications