ARTICLE | Clinical News

S: Phase II/III discontinued

June 13, 2011 7:00 AM UTC

Merck and Intercell terminated a double-blind, placebo-controlled, international Phase II/III trial of V710 after an analysis by the study's independent DMC showed that the vaccine was unlikely to demonstrate a statistically significant clinical benefit. The decision was also based on a safety concern regarding overall mortality and multi-organ dysfunction that occurred with greater frequency for the vaccine compared to placebo. However, additional analyses showed that the safety issues were not significant and that any action beyond routine safety follow-up was not warranted. Intercell said it will discuss further development plans for V710 with partner Merck. ...