Date: 2011-06-08
Type of information:
phase: 2-3
Announcement: discontinuation
Company: Merck&Co (USA) Intercell (Austria)
Product: V710
Action mechanism: investigational vaccine
Disease: prevention of Staphylococcus aureus (S. aureus) infection
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: Merck&Co and Intercell have announced that following a detailed analysis of the data 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) has unanimously recommended termination of the study.
As previously announced, following a pre-planned meeting in April, the DMC informed Merck that the trial had not met the formal futility criteria. However, the DMC recommended that enrollment in the Phase II/III clinical trial be suspended pending completion by Merck of additional analyses on the benefits and risks of vaccination. Following further review of the statistical analyses by the DMC, which also considered events that had occurred after the prespecified data cutoff date utilized for the April meeting , the recommendation to terminate was made based upon both the observation that V710 was unlikely to demonstrate a statistically significant clinical benefit as well as a safety concern regarding overall mortality and multi-organ dysfunction that occurred with greater frequency in vaccine recipients, compared with placebo recipients.
In the additional analyses that were performed, this safety difference was not found to be statistically significant and was also determined not to warrant any action beyond routine safety follow-up. Merck plans to present the final detailed findings of the clinical trial at an upcoming medical meeting.
