VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age. The study duration for each participant will be approximately 13 months.
12 Primary · 6 Secondary · Reporting Duration: From Day 01 up to Day 387
700 Total Participants · 3 Treatment Groups
Primary Treatment: Group 1 · No Placebo Group · Phase 2
Age 18+ · All Participants · 6 Total Inclusion CriteriaMark “Yes” if the following statements are true for you: