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

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
    

Detailed description: 
      This is a Phase II randomized, partially-blinded, controlled trial in 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, derived from the influenza
      A/Shanghai/2/2013 virus, 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 be assigned
      randomly to 1 of 6 groups (60 to 100 subjects per group) to receive three doses
      intramuscularly of the inactivated A/H7N9 vaccine at dosages (3.75, 7.5, or 15 mcg of HA/0.5
      mL dose) given with MF59 adjuvant using two different study vaccination schedules. The first
      and third study vaccinations will be administered to all subjects on Day 1 and approximately
      Day 169. The second study vaccination will be administered either on approximately Day 29 for
      Groups 1, 3, and 5 or approximately Day 57 for Groups 2, 4, and 6. Reactogenicity will be
      measured from the time of each study vaccination through 8 days after each study vaccination
      by the occurrence of solicited injection site and systemic reactions. Unsolicited non-serious
      adverse events (AEs) will be collected from the time of each study vaccination through
      approximately 28 days after each study vaccination. Serious adverse events (SAEs) and
      new-onset chronic medical conditions will be collected from the time of the first study
      vaccination through approximately 12 months after the last study vaccination.

      Immunogenicity testing will include performing hemagglutination inhibition (HAI) and
      neutralizing (Neut) antibody assays on serum obtained immediately prior to the first study
      vaccination (Day 1), approximately 28 days after the second study vaccination (approximately
      Day 57 for Groups 1, 3, and 5; approximately Day 85 for Groups 2, 4, and 6), immediately
      prior to the third study vaccination (approximately Day 169), and approximately 28 days after
      the third study vaccination (approximately Day 197). Subjects in Groups 1, 3, and 5 will also
      have immunogenicity testing for HAI and Neut antibody assays performed on serum obtained at
      approximately 56 days after the second study vaccination (approximately Day 85). Between 360
      and 600 subjects will be enrolled in this trial. 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-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two
      different study vaccination schedules and (2) assess the serum hemagglutination inhibition
      (HAI) antibody responses to different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an
      MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different
      study vaccination schedules following receipt of the second study vaccination. The secondary
      obectives are to (1) assess study vaccine-related unsolicited non-serious adverse events
      following receipt of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an
      MF59-adjuvanted, monovalent inactivated influenza A/H7N9 virus vaccine using two different
      study vaccination schedules, (2) assess new-onset chronic medical conditions following
      receipt of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuvanted,
      monovalent inactivated influenza A/H7N9 virus vaccine using two different study vaccination
      sched
    

Intervention name(s): MF59; Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Intervention type(s): Drug; Biological
Intervention description(s): Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg.; Monovalent inactivated split influenza virus vaccine made with HA antigen derived from the influenza A/Shanghai/2/2013 virus. Monovalent influenza A/H7N9 virus vaccine. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza, H7N9, Elderly, Vaccine, MF59 Adjuvant