Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4
Condition: Avian Influenza; Influenza; Influenza Immunisation
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are
      in good health, 19 to 64 years of age. This study is designed to assess the safety,
      reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent
      inactivated influenza A/H7N9 vaccine, when two doses are administered 21 days apart either
      sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine.
      Subjects will be randomized into one of three treatment groups. The study will enroll
      approximately 150 individuals who have no history of influenza A/H7N9 infection or prior
      receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months
      with subject participation duration of approximately 13 months. The primary objectives of
      this study are: 1) to assess the safety and reactogenicity following sequential or
      simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of
      seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses
      against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted
      2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and
      Neut antibody responses against the seasonal influenza strains at approximately 21 days
      following receipt of IIV4.
    

Detailed description: 
      This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are
      in good health, 19 to 64 years of age. This clinical trial is designed to assess the safety,
      reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent
      inactivated influenza A/H7N9 vaccine (2017 H7N9 IIV) manufactured by Sanofi Pasteur (3.75 mcg
      of HA per dose with Phosphate Buffered Saline (PBS) diluent), when two doses are administered
      21 days apart either sequentially or simultaneously (within 15 minutes) with licensed
      seasonal influenza vaccine. Subjects will be randomized into one of three treatment groups.
      Group 1 will receive two doses of AS03-adjuvanted 2017 H7N9 IIV, each dose administered IM
      approximately 21 days apart, and one dose of licensed seasonal IIV4 will be administered IM
      simultaneously (within 15 minutes) with the first dose of AS03 adjuvanted 2017 H7N9 IIV.
      Group 2 will receive one dose of IIV4 approximately 21 days prior to the IM administration of
      two doses of AS03-adjuvanted 2017 H7N9 IIV; each dose of AS03-adjuvanted 2017 H7N9 IIV will
      be given approximately 21 days apart. Group 3 will receive one dose IM of IIV4 as an
      un-blinded comparator. The study will enroll approximately 150 individuals who have no
      history of influenza A/H7N9 infection or prior receipt of an influenza virus H7 subtype
      vaccine. Study duration is approximately 16 months with subject participation duration of
      approximately 13 months. The primary objectives of this study are: 1) to assess the safety
      and reactogenicity following sequential or simultaneous IM administration of 2 doses of
      AS03-adjuvanted 2017 H7N9 IIV and one dose of seasonal influenza vaccine (IIV4); 2) to assess
      the serum HAI and Neut antibody responses against A/H7N9 at approximately 21 days following
      receipt of two doses of AS03-adjuvanted 2017 H7N9 IIV administered IM approximately 21 days
      apart; 3) to assess the serum HAI and Neut antibody responses against the seasonal influenza
      strains at approximately 21 days following receipt of IIV4. The secondary objectives are: 1)
      to assess unsolicited non-SAEs following sequential or simultaneous IM administration of
      AS03-adjuvanted 2017 H7N9 IIV and seasonal influenza vaccine (IIV4); 2) to assess MAAEs,
      including NOCMCs and PIMMCs, following sequential or simultaneous IM administration of
      AS03-adjuvanted 2017 H7N9 IIV and IIV4; 3) to assess the HAI and Neut antibody responses at
      21 days following receipt of 1 dose of AS03-adjuvanted 2017 H7N9 IIV.
    

Intervention name(s): AS03; Inactivated influenza H7N9 vaccine; Influenza Virus Quadrivalent Inactivated Vaccine; Phosphate Buffered Saline (PBS) diluent
Intervention type(s): Drug; Biological; Biological; Other
Intervention description(s): AS03 oil-in-water emulsion adjuvant.; Monovalent 2017 H7N9 inactivated influenza vaccine; A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N2) and 2 influenza B subtypes (B Yamata lineage and B Victoria lineage).; Diluent for Adjuvanted 2017 Monovalent Inactivated Influenza A/H7N9 vaccine (2017 H7N9IIV)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: AS03-adjuvanted Inactivated Influenza Vaccine; Co-Administered; Healthy Adults; Immunogenicity; Inactivated Seasonal Influenza Vaccine; Phase II; Safety