Safety/Efficacy Study of Seqirus A/H7N9 IIV With or Without MF59(R) Adjuvant to Prevent Avian Influenza
Status:
Completed
Trial end date:
2020-04-30
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant
females, 18-64 years of age. 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) manufactured by Seqirus Inc (Seqirus) administered at
different dosages (3.75 microgram mcg, 7.5 mcg and 15 mcg of hemagglutinin (HA) per dose)
given with MF59(R) adjuvant manufactured by Seqirus Inc., or without adjuvant (15 mcg of HA
per dose). Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing
Services LLC will be used to achieve certain targeted doses. Approximately 371 subjects who
are in good health and meet all eligibility criteria will be randomized into one of 4 study
groups. The study will be conducted at up to 7 Vaccine and Treatment Unit (VTEU) sites and
will last approximately 17 months, with subject participation duration of approximately 13
months. The Primary Objectives of the study are: 1) To assess the safety and reactogenicity
following receipt of two doses of 2017 H7N9 IIV administered intramuscularly (IM) at
different dosages approximately 21 days apart given with or without MF59(R) adjuvant; 2) To
assess the serum hemagglutinin inhibition (HAI) and neutralizing (Neut) antibody responses
approximately 21 days following receipt of two doses of 2017 H7N9 IIV administered IM at
different dosages approximately 21 days apart with or without MF59(R) adjuvant.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)