This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants. This study will be conducted at 6 sites and enroll 150 (up to 380) males and non-pregnant females, 19 to 64 years old, inclusive who are in good health and meet all eligibility criteria. The entire study duration is approximately 24 months and each subject participation duration is approximately 13 months. The primary objectives are: 1) To assess the safety and reactogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately 21 days apart. 2) To assess the serum HAI and Neut antibody responses to a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately 21 days apart.
Age range
19 Years – 64 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Geometric Mean Titers of Neut antibodies against the A/H5N8 antigen contained in the study vaccine
Timeframe: Day 43
Geometric Mean Titers of serum HAI antibodies against the A/H5N8 antigen contained in the study vaccine
Timeframe: Day 43
Occurrence of clinical safety laboratory AEs
Timeframe: Day 1-9
Occurrence of clinical safety laboratory AEs
Timeframe: Day 22-30
Occurrence of solicited injection site and systemic reactogenicity events
Timeframe: Day 1-9
Occurrence of solicited injection site and systemic reactogenicity events
Timeframe: Day 22-30
Occurrence of study vaccine-related SAEs
Timeframe: Day 1-387
Percentage of subjects achieving HAI seroconversion against the A/H5N8 antigen contained in the study vaccine
Timeframe: Day 43
Percentage of subjects achieving Neut seroconversion against the A/H5N8 antigen contained in the study vaccine
Timeframe: Day 43
Percentage of subjects achieving serum HAI antibody titer of 1:40 or greater against the A/H5N8 antigen contained in the study vaccine
Timeframe: Day 43
Percentage of subjects achieving serum Neut antibody titer of 1:40 or greater against the A/H5N8 antigen contained in the study vaccine
Timeframe: Day 43