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

NCT06460064 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-04-17

No results posted yet for this study

Summary

This study is a single center, randomized, double-blind, placebo-controlled, dose-finding, FIH, Phase 1 study to assess the safety, tolerability, and immunogenicity of the adjuvanted Universal Influenza Vaccine (fH1/DSP-0546LP) after IM administrations in healthy adults.

Conditions

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.

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06460064 on ClinicalTrials.gov