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news.Baxter International has announced the results of a randomized, double-blind, placebo-controlled phase III trial which showed the safety, immunogenicity, tolerability and protective efficacy of PREFLUCEL vaccine against seasonal influenza.
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Results showed nearly 80% protective efficacy against the influenza strains contained in the vaccine and a low adverse event profile.
PREFLUCEL significantly reduced duration and severity of influenza symptoms in infected subjects in the vaccinated group, as compared with the placebo group.
PREFLUCEL is manufactured using Vero cell technology and offers an innovative method of unadulterated vaccine production compared to conventional embryonated chicken egg production, Baxter said.
Baxter BioScience vice president of Global R&D and senior author of Lancet Hartmut Ehrlichsaid that PREFLUCEL had demonstrated robust immunogenicity and protective efficacy against common circulating flu strains, and so may provide an important alternative to egg-based vaccines in planning seasonal influenza prevention efforts with a shorter production timeline.
Baxter hopes to get approval for PREFLUCEL in other European countries apart from Austria and the Czech Republic (which already have approval) in 2011 through a repeat Mutual Recognition Procedure (rMRP).