The second Phase II clinical trial will be a randomized, single-blind, controlled study in 48 healthy adolescents and children. The study will test the rabies monoclonal antibody combination product in association with Sanofi Pasteur’s rabies vaccine and will compare it to the human rabies immune globulin, which is currently administered with the vaccine. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity.
This clinical trial aims to generate safety data in children in Asia, complementing the safety data generated in adult volunteers during a Phase I trial conducted in India. Jointly, the combined data allows a swift Phase III clinical evaluation of the monoclonal antibody combination in individuals exposed to rabies in endemic areas like Asia.
At the beginning of 2008, Crucell announced a collaboration and commercialization agreement with Sanofi Pasteur for the company’s rabies monoclonal antibody combination product to be used in combination with rabies vaccines for post-exposure prophylaxis against this fatal disease. Crucell received an initial payment of E10 million following the execution of the agreement and will be eligible for milestone payments of up to E66.5 million.