Phase 3 study of Preflucel for protection against seasonal influenza
Baxter announced results from its Phase 3 study of Preflucel in protecting against seasonal influenza. This study was a randomized, double-blind, placebo-controlled trial conducted in more than 7,200 healthy volunteers in the U.S. during the 2008/2009 influenza season. The study was primarily designed to determine the efficacy of the vaccine in preventing culture-confirmed influenza infection (CCII) with viruses that were matched to one of the strains contained in the vaccine.
Study results indicated that participants responded positively to the vaccine, with 78.5% protective efficacy against CCII and robust immune responses (measured as seroprotection rates) against the three viral strains contained in the vaccine: A/H1N1- (88.0%), A/H3N2- (93.3%) and B-specific (97.1%). In addition to protection, study investigators found significantly reduced duration and severity of influenza symptoms in infected subjects in the vaccinated group, as compared with the placebo group in a subsequent analysis. The vaccine was well tolerated, with no treatment-related serious adverse events reported during the trial.
Preflucel is a seasonal vaccine composed of purified, inactivated split influenza virions, manufactured using Vero cell technology instead of the conventional embryonated chicken egg production.
For more information call (800) 422-9837 or visit www.baxter.com.