H7N9 Mix and Match With MF59 in Healthy Elderly Persons
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
This is a Phase II randomized, partially-blinded, controlled trial in 360 (up to 600) males
and females, 65 years of age and older, who are in good health and meet all eligibility
criteria. This clinical trial is designed to assess the safety, reactogenicity, and
immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine manufactured by
Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5, or
15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and
Diagnostics. Subjects will receive three doses of the vaccine. Safety, reactogenicity, and
immunogenicity data will be collected at standard time points with safety follow-up to
continue through one year post dose 2. Study Duration is approximately 30 months and Subject
Participation is approximately 18 months. The primary objectives are to (1) assess the safety
and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an
MF59-adjuv
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)