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