Multimeric-001 (M-001) is a recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
Multimeric-001 is a vaccine candidate designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza.
Multimeric-001 is intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect.
Multimeric-001 will be administered in this phase 3 trial as an intermuscular injection with 1mg dose of twice:
- Once at Day 0, and once at Day 21.
Clinical Trial NCT03450915: A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine
This Phase 3 trial plans to enroll a total of 12,000 participants aged 50+ over two years.
Participants will be immunized twice with the M-001 universal influenza vaccine candidate or placebo and then followed for up to 2 seasons.
The trial will evaluate the number of influenza cases in each group and the severity of illness during the follow-up period.
This trial is expected to take place in eastern European countries and begin prior to the 2018/19 Northern Hemisphere flu season.
In a total of 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic.