Safety/Efficacy Study of Seqirus A/H7N9 IIV With or Without MF59(R) Adjuvant to Prevent Avian Influenza
Condition: Avian Influenza; Influenza Immunisation
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant
      females, 18-64 years of age. This clinical trial is designed to assess the safety,
      reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza
      A/H7N9 virus vaccine (2017 H7N9 IIV) manufactured by Seqirus Inc (Seqirus) administered at
      different dosages (3.75 microgram mcg, 7.5 mcg and 15 mcg of hemagglutinin (HA) per dose)
      given with MF59(R) adjuvant manufactured by Seqirus Inc., or without adjuvant (15 mcg of HA
      per dose). Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing
      Services LLC will be used to achieve certain targeted doses. Approximately 371 subjects who
      are in good health and meet all eligibility criteria will be randomized into one of 4 study
      groups. The study will be conducted at up to 7 Vaccine and Treatment Unit (VTEU) sites and
      will last approximately 17 months, with subject participation duration of approximately 13
      months. The Primary Objectives of the study are: 1) To assess the safety and reactogenicity
      following receipt of two doses of 2017 H7N9 IIV administered intramuscularly (IM) at
      different dosages approximately 21 days apart given with or without MF59(R) adjuvant; 2) To
      assess the serum hemagglutinin inhibition (HAI) and neutralizing (Neut) antibody responses
      approximately 21 days following receipt of two doses of 2017 H7N9 IIV administered IM at
      different dosages approximately 21 days apart with or without MF59(R) adjuvant.
    

Detailed description: 
      This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant
      females, 18-64 years of age. This clinical trial is designed to assess the safety,
      reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza
      A/H7N9 virus vaccine (2017 H7N9 IIV) manufactured by Seqirus Inc (Seqirus) administered at
      different dosages (3.75 mcg, 7.5 mcg and 15 mcg of hemagglutinin (HA) per dose) given with
      MF59(R) adjuvant manufactured by Seqirus Inc., or without adjuvant (15 mcg of HA per dose).
      Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing Services LLC
      will be used to achieve certain targeted doses. Approximately 371 subjects who are in good
      health and meet all eligibility criteria will be randomized into one of 4 study groups. The
      study will be conducted at up to 7 Vaccine and Treatment Unit (VTEU) sites and will last
      approximately 17 months, with subject participation duration of approximately 13 months. The
      Primary Objectives of the study are: 1) To assess the safety and reactogenicity following
      receipt of two doses of 2017 H7N9 IIV administered intramuscularly (IM) at different dosages
      approximately 21 days apart given with or without MF59(R) adjuvant; 2) To assess the serum
      hemagglutinin inhibition (HAI) and Neutralizing (Neut) antibody responses approximately 21
      days following receipt of two doses of 2017 H7N9 IIV administered IM at different dosages
      approximately 21 days apart with or without MF59(R) adjuvant.

      The secondary Objectives are: 1) To assess all unsolicited non-serious Adverse Events (AEs)
      following receipt of two doses of a 2017 H7N9 IIV administered IM at different dosages
      approximately 21 days apart with or without MF59(R) adjuvant; 2) To assess medically-attended
      adverse events (MAAEs) including new-onset chronic medical conditions (NOCMCs), potentially
      immune-mediated medical conditions (PIMMCs), and all Serious Adverse Events (SAEs) following
      receipt of two doses of a 2017 H7N9 IIV administered IM at different dosages approximately 21
      days apart with or without MF59(R) adjuvant; 3) To assess the serum HAI and Neut antibody
      responses approximately 7 and 21 days following receipt of a single dose, and approximately 7
      days following receipt of two doses of 2017 H7N9 IIV administered IM at different dosages
      approximately 21 days apart with or without MF59(R) adjuvant.
    

Intervention name(s): A/H7N9; MF59; Phosphate Buffered Saline (PBS) diluent
Intervention type(s): Biological; Drug; Other
Intervention description(s): Monovalent inactivated, "subunit" influenza virus vaccine containing the HA and NA from influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS genes from A/Puerto Rico/8/1934 (H1N1).; Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.; Diluent for Influenza Virus Vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: A/H7N9; Healthy Adults; Immunogenicity; Influenza vaccine; MF59(R) adjuvant; Reactogenicity; Safety