Bavarian Nordic announced the completion of enrollment of a Phase III clinical study for its smallpox vaccine, Imvamune.

Bavarian Nordic announced the completion of enrollment of a Phase III 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. This is the second and final study agreed with the 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 III 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.