Seqirus
This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment groups, stratified by age group (18-64 years and ≥65 years) and by poultry worker status (yes/no). Each subject will receive a priming influenza vaccine injection on Day 1 and Day 22 and a booster vaccination on Day 202. Subjects will be followed up for approximately 6 months after the booster injection. The primary immunogenicity analysis is based on antibody responses against H5N8 and H5N6 as measured by hemagglutination inhibition (HI) assay on Day 1, Day 22, Day 29, Day 43, Day 202, Day 209 (H5N8 only), and Day 223.
Influenza, Human
Infections
Respiratory Tract Infections
Virus Diseases
Infection Viral
aH5N8c on Day 1
aH5N6c on Day 1
aH5N8c on Day 22
aH5N6c on Day 22
aH5N8c on Day 202
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 480 participants |
Masking: | Triple |
Primary Purpose: | Prevention |
Official Title: | A Phase 2, Multi-Center, Randomized, Observer-Blind Study, to Evaluate Safety and Immunogenicity of Homologous or Heterologous Priming and Booster Vaccinations With H5N8 or H5N6 MF59-adjuvanted, Cell Culture-derived Influenza Vaccine in Healthy Subjects ≥18 Years of Age |
Actual Study Start Date : | June 7, 2023 |
Estimated Primary Completion Date : | April 2024 |
Estimated Study Completion Date : | October 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm A Eligible subjects who have been randomized to receive aH5N8c on Day 1, Day 22 and Day 202 |
Biological: aH5N8c on Day 1 Biological: aH5N8c on Day 22 Biological: aH5N8c on Day 202 |
Experimental: Arm B Eligible subjects who have been randomized to receive aH5N8c on Day 1, aH5N6c on Day 22, and aH5N8c on Day 202 |
Biological: aH5N8c on Day 1 Biological: aH5N6c on Day 22 Biological: aH5N8c on Day 202 |
Experimental: Arm C Eligible subjects who have been randomized to receive aH5N6c on Day 1 and aH5N8c on Day 22 and Day 202 |
Biological: aH5N6c on Day 1 Biological: aH5N8c on Day 22 Biological: aH5N8c on Day 202 |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
Not yet recruiting
Lifeline Primary Care
Lilburn, Georgia, United States, 30047
Not yet recruiting
Georgia Clinic
Norcross, Georgia, United States, 30092
Not yet recruiting
Velocity Clinical Research
Sioux City, Iowa, United States, 51106
Not yet recruiting
Meridian Clinical Research
Baton Rouge, Louisiana, United States, 70809
Not yet recruiting
Meridian Clinical Research
Grand Island, Nebraska, United States, 68803
Not yet recruiting
Meridian Clinical Research
Norfolk, Nebraska, United States, 68701
Not yet recruiting
Medical Care LLC
Elizabethton, Tennessee, United States, 37643
Not yet recruiting
Cope Family Medicine
Salt Lake City, Utah, United States, 84010