This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females 19 years and older that is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) administered at different dosages given with AS03 adjuvant and phosphate buffered saline (PBS) diluent, with AS03 adjuvant only, and without adjuvant. Eligible subjects will be randomized into 5 study groups, stratified by age. The study will enroll up to 420 individuals 19-64 years old and up to 300 individuals who are 65 years old and older. Study duration is approximately 16 months with subject participation duration approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart given with or without AS03 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart with or without AS03 adjuvant, stratified by age of recipient.
Age range
19 Years – 99 Years
Sex
ALL
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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 (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Timeframe: Day 43
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Timeframe: Day 43
Number of Participants With Clinical Safety Laboratory Adverse Events
Timeframe: Day 8
Number of Participants With Clinical Safety Laboratory Adverse Events
Timeframe: Day 29
Number of Participants Reporting Solicited Injection Site Events
Timeframe: Day 1 to Day 8
Number of Participants Reporting Solicited Injection Site Events
Timeframe: Day 22 to Day 29
Number of Participants Reporting Study Vaccine-related Serious Adverse Events (SAEs)
Timeframe: Day 1 to Day 387
Number of Participants Reporting Systemic Reactogenicity Events
Timeframe: Day 1 to Day 8
Number of Participants Reporting Systemic Reactogenicity Events
Timeframe: Day 22 to Day 29
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titer of 1:40 or Greater
Timeframe: Day 43
Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titer of 1:40 or Greater
Timeframe: Day 43
Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies
Timeframe: Day 43
Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies
Timeframe: Day 43