H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults
Condition: Avian Influenza; Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): AS03; MF59 adjuvant; Monovalent Influenza A/H5N8 vaccine
Intervention type(s): Drug; Drug; Biological
Intervention description(s): AS03 oil-in-water emulsion adjuvant.; Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.; Monovalent inactivated influenza A/H5N8 virus vaccine for IM injection. prepared from influenza virus propagated in chicken egg fluid using seed virus prepared from the candidate vaccine virus (CVV), influenza virus A/gyrfalcon/Washington/41088-6/2014(H5N8)-PR8-IDCDC-RG43A (abbreviated as IDCDC-RG43A).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: A/H5N8; AS03; Controlled; Double-Blind; Immunogenicity; Inactivated; Influenza; MF59; Monovalent; Randomized; Reactogenicity; Safety; Trial; Vaccine