H7N9 Mix and Match With MF59 in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013; MF59
Intervention type(s): Biological; Drug
Intervention description(s): Monovalent influenza A/H7N9 virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension. sanofi A/H7N9 antigen. Group 1 receives 3.75mcg A/H7N9 IM on days 1 and 21, Group 2 receives 7.5 mcg IM on days 1 and 21, Group 3, 4, 5, & 6 receives 15 mcg IM on days 1 and 21, and Group 7 receives 45 mcg IM on days 1 and 21.; MF59 adjuvant is an oil-in-water emulsion composed of a small amount of squalene administered with different dosages. Group 1, 2 & 3 receives 0.7 ml of MF59 Intramuscularly (IM) on days 0 and 21. Group 4 receives MF59 on day 0, Group 5 receives MF59 on Day 21.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: A/H7N9,Adjuvant,Immunogenicity,Influenza,MF59,Monovalent,Vaccine