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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)