Influenza Clinical Trial
Official title:
A Phase I Randomized, Double-Blind, Controlled Trial in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of a Monovalent Inactivated Influenza A/H5N8 Virus Vaccine Administered Intramuscularly at Different Dosages Given With or Without AS03 or MF59 Adjuvants
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.
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 which include screening hematology, chemistry and erythrocyte sedimentation rate (ESR) laboratory evaluations. 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. The primary objectives of this study is to assess 1) the safety and reactogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine and 2) the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses to a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or without AS03 or MF59 approximately 21 days apart. The secondary objectives of this study are to 1) assess study vaccine-related unsolicited non-serious adverse events following receipt of two doses of a monovalent inactivated influenza A/H5N8 virus vaccine, 2) assess medically attended adverse events (MAAEs) including new-onset chronic medical conditions and immune-mediated or auto-inflammatory adverse events of special interest following receipt of two doses of a monovalent inactivated influenza A/H5N8 virus vaccine, and 3) assess the serum HAI and Neut antibody responses to a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of one dose administered intramuscularly at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or without AS03 or MF59. This study will span approximately 24 months. Subject participation duration will span approximately 13 months. ;
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