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news.Bavarian Nordic has completed enrollment of a Phase 3 clinical study designed to demonstrate non-inferiority between its investigational, non-replicating smallpox vaccine, IMVAMUNE and ACAM2000, the current U.S. licensed, and replicating smallpox vaccine.
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This is the second and final study agreed with the U.S. Food and Drug Administration (FDA) to support the registration of liquid-frozen IMVAMUNE.
The first study, a lot consistency study in 4,000 healthy individuals, was successfully completed in 2015.
The Phase 3 non-inferiority study enrolled 440 subjects at a U.S. military garrison in South Korea led by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in collaboration with the U.S. Defense Health Agency. All subjects will have completed the study within second quarter of 2017, and top line data is anticipated in the second half of 2017.
Bavarian Nordic president & CEO Paul Chaplin said: “Completion of enrolment of this study represents a significant milestone in the collaboration between Bavarian Nordic, and multiple federal agencies.
"IMVAMUNE has served as the cornerstone for our Company over the past decade and we will continue to work with the U.S. Government to meet their stated goal of protecting 66 million Americans who are in need of a safer smallpox vaccine. We look forward reporting these data and working with the authorities in the process towards U.S. licensure.”
Bavarian Nordic has to-date delivered 28 million doses of liquid-frozen IMVAMUNE to the U.S. Strategic National Stockpile.
Federal funding acknowledgments
The Phase 3 study comparing the safety and immunogenicity of IMVAMUNE to ACAM2000 has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100200700034C.