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

Influenza Clinical Trial

Official title:
A Randomized First-in-human, Observer-blind, 3-arm Study to Evaluate Safety, Tolerability, and Immunogenicity of a Single Administration of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccine

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05581407
Study type Interventional
Source LiteVax BV
Contact
Status Completed
Phase Phase 1
Start date October 3, 2022
Completion date October 23, 2023
View Details
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