BiondVax's Universal Flu Vaccine Clinical Trial Completes First Season's Enrollment

"We are pleased with the progress of our universal flu vaccine's pivotal Phase 3 trial. Our partners are doing a wonderful job conducting this challenging study," Dr. Tamar Ben-Yedidia, BiondVax's Chief Science Officer and co-inventor of M-001, said. "The trial aims to show the extent to which M-001 protects people against influenza illness, regardless of flu strain."

To date, participants were recruited in 55 clinical trial sites in four European countries. Some additional European countries and sites are expected to participate in the Phase 3 trial's second season.

In 6 completed clinical trials in 698 young adult to elderly participants, M-001 has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains. A recombinant protein consisting of nine common and conserved influenza virus epitopes, M-001 is a single, unchanging vaccine formulation. It is designed to induce T-cell immune responses and to serve as a common denominator to current, future, seasonal, and pandemic influenza.

As previously reported, the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) reviewed the trial design and allowed BiondVax to proceed. Regulatory authorities in countries in which the trial is being conducted have also allowed the trial to proceed. Participants are volunteers and have provided informed consent.

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conducted have also allowed the trial to proceed. Participants are volunteers and have provided informed consent.