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

Influenza Clinical Trial

Official title:
A Single Center, Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1 Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine "fH1/DSP-0546LP" After Intramuscular (IM) Administrations in Healthy Adults

Clinical Trial 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.

Clinical Trial Description

This will be a single center, randomized, placebo-controlled, double-blind study. In this study, safety, tolerability, and immunogenicity of fH1 formulated with DSP-0546LP will be assessed after IM administration in healthy adults aged 18 to 40 years. This study includes 6 cohorts, with a combination of 2 dose levels of fH1 (2 and 8 μg), 3 dose levels of DSP-0546LP (2.5, 5, and 10 μg), and placebo. Each dose level of fH1 will be combined with the low, medium, and high dose level of DSP-0546LP. Subjects will receive 2 administrations at 3-week intervals. Randomized subjects will undergo 11 visits including screening, 2 administration visits (Day 1 and Day 22 [± 2]), and follow-up visits on Day 4 (+1) (telephone contact), Day 8 (± 1), Day 25 (+1) (telephone contact), Day 29 (± 1), Day 36 (± 2), Day 50 (± 4), Day 204 (± 7), and Day 386 (± 10). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06460064
Study type Interventional
Source Sumitomo Pharma Co., Ltd.
Contact Sumitomo Pharma Co., Ltd.
Phone E-mail only
Email cc@sumitomo-pharma.co.jp
Status Not yet recruiting
Phase Phase 1
Start date June 26, 2024
Completion date March 27, 2026
View Details
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