Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older

About the trial

Sponsor

Sanofi Pasteur, a Sanofi Company

Tested

Panblok + MF59 Dose 1 (biological), Panblok + MF59 Dose 2 (biological), Unadjuvanted Panblok Dose 3 (biological)

Dates

Started 2022-11-03; completion 2024-02-13

Results posted

Yes

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.

From ClinicalTrials.gov, last updated 2025-09-24. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi Pasteur Inc. reported $5,000 in research payments for this study in 2025 (1 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.