Clinical Trials Logo
  1. Home
  2. Influenza
  3. NCT06460064

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
See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A