This is a Phase II randomized, double-blinded, controlled study in up to 700 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine manufactured by Sanofi Pasteur administered to healthy adults at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL dose). The A/H7N9 vaccine was made with HA antigen derived from the influenza A/Shanghai/2/2013 virus. Subjects will be randomly assigned to 1 of 7 groups (up to 100 subjects per group) to receive two doses of the A/H7N9 vaccine with and without MF59 adjuvant delivered intramuscularly approximately 21 days apart. The same dosage of A/H7N9 vaccine will be given to subjects at both their first and second study vaccinations. The primary objectives are to: 1) assess the safety and reactogenicity of a monovalent influenza A/H7N9 virus vaccine following receipt of two doses administered with and without MF59 adjuvant; and 2) assess new-onset chronic medical conditions following receipt of two doses of a monovalent influenza A/H7N9 virus vaccine administered with and without MF59 adjuvant. The duration of the study for each subject will be approximately 13 months.
This is a Phase II randomized, double-blinded, controlled study in up to 700 males and non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with and without MF59 adjuvant and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL dose). Subjects will receive two doses via intramuscular injection, approximately 21 days apart. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. The duration of the study for each subject will be approximately 13 months.