NCT06460064View on ClinicalTrials.gov

First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

June 26, 2024

Primary Completion Date

March 27, 2026

Study Completion Date

March 27, 2026

Conditions
Influenza
Interventions
BIOLOGICAL

fH1 2 ug

2 administrations at 3-week intervals.

BIOLOGICAL

fH1 8 ug

2 administrations at 3-week intervals.

BIOLOGICAL

DSP-0546LP 2.5 ug

2 administrations at 3-week intervals.

BIOLOGICAL

DSP-0546LP 5 ug

2 administrations at 3-week intervals.

BIOLOGICAL

DSP-0546LP 10 ug

2 administrations at 3-week intervals.

BIOLOGICAL

Placebo

2 administrations at 3-week intervals.

Trial Locations (1)

9000

Center for Vaccinology, Ghent

All Listed Sponsors
lead

Sumitomo Pharma Co., Ltd.

INDUSTRY

NCT06460064 - First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP | Biotech Hunter | Biotech Hunter