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Valneva SE Provides Update on Phase II/III Interim Analysis of Its Pseudomonas Aeruginosa Vaccine Candidate


Wednesday, 30 Oct 2013 01:05pm EDT 

Valneva SE announced an update on the Phase II/III efficacy study interim analysis of its Pseudomonas aeruginosa vaccine candidate. The development partners - Valneva SE and Novartis Vaccines & Diagnostics have initiated discussions on trial continuation in agreement with the recommendations of a Data Monitoring Committee (DMC) following their data review on the primary efficacy endpoint and safety data from 394 patients. Although the stringent pre-specified futility criterion in regards to the primary efficacy endpoint was formally met, the difference in all-cause mortality rates (at Day 28) between the vaccine and placebo group in this randomized, placebo controlled double blind study, was considered clinically meaningful and in line with the trend observed in the previous study. Additionally there were no concerns with regard to the observed safety profile. IC43 is targeted for ventilated Intensive Care (ICU) patients, who are only vaccinated at hospital admission and are at particular risk of life threatening Pseudomonas infections. The primary endpoint of the Phase II/III trial is the mortality rate from all causes of death (all-cause mortality) on Day 28. The futility analysis for the primary endpoint midway through the study, conducted in critically ill patients (or people), was factored into its design to allow early discontinuation , in case it would appear unlikely to see a meaningful vaccine effect when the study has been completed. 

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