2017 A/H7N9 IIV Revaccination
Condition: Avian Influenza; Influenza Immunisation
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years
      of age, inclusive, who are in good health and meet all eligibility criteria. This clinical
      trial is designed to assess the safety, reactogenicity and immunogenicity of one dose of a
      monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV),
      administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or
      without AS03 adjuvant to subjects primed with a monovalent inactivated split influenza 2013
      A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who
      are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent will be used to achieve the
      targeted dosage. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit
      (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with
      subject participation duration up to 13 months. The primary objectives are: 1) to assess the
      safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following
      receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition
      (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine.
    

Detailed description: 
      This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years
      of age, inclusive, who are in good health and meet all eligibility criteria, which include a
      screening erythrocyte sedimentation rate (ESR) laboratory evaluation. This clinical trial is
      designed to assess the safety, reactogenicity and immunogenicity of one dose of a monovalent
      inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV) manufactured by
      Sanofi Pasteur (SP), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per
      dose, given with or without AS03 adjuvant manufactured by GlaxoSmithKline Biologicals (GSK),
      to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine
      (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve.
      Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing Services LLC
      will be used to achieve the targeted dosage. Subjects who received the 2013 A/H7N9 IIV in
      DMID Protocols 13-0032 and 13-0033 or are A/H7 IIV-naïve will be stratified by prior receipt
      of 2013 A/H7N9 IIV, as well as by site and prior receipt of licensed, seasonal influenza
      vaccine (defined as receipt of at least one of the 2017-2018 and/or 2018-2019 licensed,
      seasonal influenza vaccines versus none), then randomly assigned in a 1:1 ratio to 1 of 2
      treatment arms to receive 1 dose of 2017 A/H7N9 IIV at 3.75 mcg HA per dose with or without
      AS03 adjuvant. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU)
      sites (including their subcontractors). Study duration is approximately 17 months with
      subject participation duration up to 13 months. The primary objectives are: 1) to assess the
      safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following
      receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition
      (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine.
      Secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following
      receipt of the study vaccine; 2) to assess medically-attended adverse events (MAAEs),
      including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated
      medical conditions (PIMMCs), following receipt of the study vaccine; 3) To assess the
      kinetics and durability of serum HAI and Neut antibody responses following receipt of the
      study vaccine.
    

Intervention name(s): A/H7N9; AS03; Phosphate Buffered Saline (PBS) diluent
Intervention type(s): Biological; Drug; Other
Intervention description(s): Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).; AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.; 0.006M PBS diluent for Influenza Virus Vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: A/H7N9 Inactivated Influenza Vaccine; AS03 Adjuvant; Immunogenicity; Influenza; Phase II; Reactogenicity; Safety; Vaccine