Sanofi 2017 H7N9 With/Without AS03 in Adults/Elderly
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 19 years and older that is designed to assess the safety, reactogenicity, and
      immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine
      (2017 H7N9 IIV) administered at different dosages given with AS03 adjuvant and phosphate
      buffered saline (PBS) diluent, with AS03 adjuvant only, and without adjuvant. Eligible
      subjects will be randomized into 5 study groups, stratified by age. The study will enroll up
      to 420 individuals 19-64 years old and up to 300 individuals who are 65 years old and older.
      Study duration is approximately 16 months with subject participation duration approximately
      13 months. The primary objectives of this study are: 1) to assess the safety and
      reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly
      at different dosages approximately 21 days apart given with or without AS03 adjuvant; 2) to
      assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses
      following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different
      dosages approximately 21 days apart with or without AS03 adjuvant, stratified by age of
      recipient.
    

Detailed description: 
      This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant
      females 19 years and older. 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) administered at different dosages given with or without
      adjuvant. 3.75 mcg of HA per dose will be administered with phosphate buffered saline (PBS)
      diluent and AS03 adjuvant, 7.5 mcg and 15 mcg of HA per dose will be administered with AS03
      adjuvant only, and 15 mcg and 45 mcg of HA per dose will be administered without adjuvant.
      Eligible subjects will be randomized into one of 5 study groups, stratified by age. The study
      will enroll up to 420 individuals 19-64 years old and up to 300 individuals who are 65 years
      old and older. The study duration is approximately 16 months with subject participation
      duration approximately 13 months. The primary objectives of this study are: 1) to assess the
      safety and reactogenicity following receipt of two doses of 2017 H7N9 IIV administered
      intramuscularly at different dosages approximately 21 days apart given with or without AS03
      adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut)
      antibody responses following receipt of two doses of 2017 H7N9 IIV administered
      intramuscularly at different dosages approximately 21 days apart with or without AS03
      adjuvant, stratified by age of recipient. The secondary objectives are: 1) to assess
      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 AS03
      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 AS03 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
      AS03 adjuvant, stratified by age of recipient.
    

Intervention name(s): AS03; Inactivated influenza H7N9 vaccine; Phosphate Buffered Saline (PBS) diluent
Intervention type(s): Drug; Biological; Other
Intervention description(s): Oil-in-water emulsion based adjuvant system.; Monovalent 2017 H7N9 inactivated influenza vaccine; Diluent for 2017 Monovalent Inactivated Influenza A/H7N9 virus vaccine (2017 H7N9 IIV)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: A/H7N9; Immunogenicity; Influenza; Safety; Sanofi Pasteur; Vaccine