Two Doses of Multimeric-001 (M-001) Followed by Two Doses of an Influenza A/H7N9 Vaccine
Status:
Not yet recruiting
Trial end date:
0000-00-00
Target enrollment:
Participant gender:
Summary
This is a Phase II randomized, double-blind, placebo-controlled trial in 240 males and
non-pregnant females, 18 to 45 years old, inclusive, who are in good health and meet all
eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity,
and immunogenicity of two priming doses of M-001 followed by boosting with two doses of
MF59-adjuvanted or non-adjuvanted monovalent influenza A/H7N9 IIV. The monovalent influenza
A/H7N9 IIV was derived from the HA of the influenza A/Shanghai/2/2013 (H7N9) virus. Primary
objectives: To assess the safety and reactogenicity of M-001 vaccine following receipt of
two doses; To assess the safety and reactogenicity of a monovalent inactivated influenza
A/H7N9 vaccine (A/H7N9 IIV; two doses) administered with or without MF59 adjuvant following
immunization with two doses of M-001 vaccine or placebo, and to assess the serum
hemagglutination inhibition (HAI) antibody responses to the A/H7N9 IIV virus after receipt
of the first and second dose of MF59 adjuvanted or non-adjuvanted A/H7N9 IIV when
administered to adults following receipt of placebo or two doses of M-001 vaccine.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)