H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults
Status:
Completed
Trial end date:
2018-01-30
Target enrollment:
Participant gender:
Summary
This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant
females, 19 to 64 years old, inclusive, 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/H5N8 virus vaccine manufactured by
bioCSL administered at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or
without AS03 or MF59 adjuvants manufactured by GlaxoSmithKline Biologicals and Novartis
Vaccines and Diagnostics, respectively.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)