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MedImmune next-generation FluMist

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

MedImmune has initiated a pivotal Phase III head-to-head study comparing its next-generation, refrigerator-stable formulation of its intranasal flu vaccine FluMist to the trivalent injectable vaccine, the firm says Oct. 20. FluMist is a frozen, live, attenuated trivalent vaccine. The double-blind study will enroll 7,000 children between the ages of 6 and 59 months. A bridging study is also being conducted to establish the new cold-adapted intranasal formulation (CAIV-T) as equivalent to frozen FluMist. MedImmune has already conducted two Phase III trials in 4,400 children with a history of respiratory illness or asthma; data were presented at the Pediatric Academic Societies' annual meeting in May...
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