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Phase II/III trial of S. aureus vaccine V710 fails, DMC recommends suspension of enrolment
Whitehouse Station New Jersey | Wednesday, April 13, 2011, 16:00 Hrs  [IST]

Merck known as MSD outside the United States and Canada, and Intercell AG announced that following a pre-specified interim analysis from the phase II/III clinical trial evaluating V710, an investigational vaccine for the prevention of Staphylococcus aureus (S. aureus) infection, the independent Data Monitoring Committee (DMC) recommended suspension of enrolment.

Although the trial did not meet the pre-specified futility criteria, the DMC nonetheless recommended suspension of enrolment pending further analyses of the benefit/risk profile of the vaccine candidate. Merck and Intercell plan to provide a further update when analyses have been completed.

S. aureus is a leading cause of hospital acquired infections. In addition to bloodstream infections with a mortality rate of up to 35 percent, infections of bone, heart and other inner organs can often lead to serious health complications and death. Today, approximately 50 per cent of S. aureus strains isolated in hospitals worldwide are resistant to multiple antibiotics, rendering staphylococcal disease management increasingly difficult and challenging.

Intercell AG is an innovative biotechnology company that develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs.

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