2013/2017 H7N9 Prime-Boost Interval
Condition: Avian Influenza; Influenza Immunisation
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a trial designed to assess the safety, reactogenicity and immunogenicity of one or
      two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus vaccines
      administered intramuscularly at different dosages, given with or without AS03 adjuvant, using
      different vaccination schedules. This trial will enroll up to 180 males and non-pregnant
      females, 19 to 50 years of age, who are in good health and who are influenza A/H7 naïve.
      Subjects will be randomly assigned to 1 of 6 treatment arms (30 subjects per arm) to evaluate
      the interval between the first and second doses and the presence of the adjuvant in the first
      and second doses. The neuraminidase-specific antibody response and the neuraminidase content
      of the Inactivated Influenza Virus Vaccine will be determined using tests that are currently
      under development. Study duration is approximately 22 months with subject participation
      duration of approximately 18 months. The primary objectives of the study are: 1) to assess
      the safety and reactogenicity of 2013 and 2017 A/H7N9 IIVs given with or without AS03
      adjuvant following receipt of each study vaccine; 2) to assess the serum hemagglutination
      inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the second
      study vaccine.
    

Detailed description: 
      This is a Phase II trial designed to assess the safety, reactogenicity and immunogenicity of
      one or two doses of monovalent inactivated split influenza 2013 and 2017 A/H7N9 virus
      vaccines (2013 and 2017 A/H7N9 IIVs) administered intramuscularly at different dosages (3.75
      or 15 mcg of hemagglutinin (HA) per dose), given with or without AS03 adjuvant, using
      different heterologous and homologous prime-boost vaccination schedules. Phosphate buffered
      saline (PBS) diluent may be used to achieve targeted dosages. This trial will enroll up to
      180 males and non-pregnant females, 19 to 50 years of age, inclusive, who are in good health
      and meet all eligibility criteria and who are influenza A/H7 vaccine/infection naïve by
      medical history. Subjects will be randomly assigned to 1 of 6 treatment arms (30 subjects per
      arm) evaluating the interval between the priming (first) and boosting (second) doses and the
      presence of the adjuvant in the priming (first) and boosting (second) doses. The
      neuraminidase-specific antibody response and the neuraminidase content of the Inactivated
      Influenza Virus Vaccine will be determined using tests that are currently under development.
      Study duration is approximately 22 months with subject participation duration of
      approximately 18 months. The primary objectives of the study are: 1) to assess the safety and
      reactogenicity of 2013 and 2017 A/H7N9 IIVs given with or without AS03 adjuvant following
      receipt of each study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and
      neutralizing (Neut) antibody responses following receipt of the second study vaccine. The
      secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following
      receipt of each 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 each study vaccine; 3) to assess the
      kinetics and durability of serum HAI and Neut antibody responses following receipt of each
      study vaccine.
    

Intervention name(s): A/H7N9; AS03; Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013; Phosphate Buffered Saline (PBS) diluent
Intervention type(s): Biological; Drug; Biological; Other
Intervention description(s): Monovalent split 2017 A/H7N9 Inictivated Influenza Virus vaccine containing the HA and 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).; AS03 oil-in-water emulsion adjuvant.; Monovalent split 2013 A/H7N9 Inavtivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).; Diluent for Influenza Virus Vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: A/H7N9; Adults; AS03; Immunogenicity; Influenza; Prime-Boost; Reactogenicity; Safety; Vaccine