Sanofi Pasteur has initiated a Phase II clinical study of a vaccine to prevent Clostridium difficile infections.
The study is aimed at evaluating the prevention of the first episode of infection in at-risk individuals, such as adults with impending hospitalisations, or current or impending residence in a long-term care or rehabilitation facility.
The study will investigate the safety and immunogenicity of different formulations of a Clostridium difficile toxoid vaccine in at-risk individuals between the ages 40 and 75 years.
The study will recruit more than 650 participants and will be conducted at 30 healthcare centres across the US.
The US Food and Drug Administration has recently granted fast-track designation to the investigational vaccine candidate.
