Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4
Status:
Completed
Trial end date:
2019-07-25
Target enrollment:
Participant gender:
Summary
This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are
in good health, 19 to 64 years of age. This study is designed to assess the safety,
reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent
inactivated influenza A/H7N9 vaccine, when two doses are administered 21 days apart either
sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine.
Subjects will be randomized into one of three treatment groups. The study will enroll
approximately 150 individuals who have no history of influenza A/H7N9 infection or prior
receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months
with subject participation duration of approximately 13 months. The primary objectives of
this study are: 1) to assess the safety and reactogenicity following sequential or
simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of
seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses
against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted
2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and
Neut antibody responses against the seasonal influenza strains at approximately 21 days
following receipt of IIV4.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)