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H1N1 vaccines move step closer

GSK's first clinical trial for its adjuvanted pandemic vaccine is underway. Meanwhile, Sanofi Pasteur has submitted a supplemental application for licensing of its H1N1 2009 monovalent vaccine

GlaxoSmithKline's (GSK) first clinical trial for its adjuvanted pandemic vaccine is underway. Meanwhile, Sanofi Pasteur has submitted a supplemental application for licensing of its A(H1N1) 2009 monovalent vaccine to the US Food and Drug Administration (FDA). 

Enrolment for the GSK study has been completed and the clinical trial, being conducted in Germany, will assess the use of the vaccine in healthy adults. Initial data is expected to be available for sharing with regulatory authorities in September. Further trials of the pandemic (H1N1) 2009 adjunvanted vaccine covering infants, children, adults and the elderly will commence over the coming weeks across Europe, Canada and the US.

Sanofi Pasteur's supplemental application follows recent recommendations by the FDA to evaluate the influenza A (H1N1) 2009 monovalent vaccines using the same regulatory process by which it approves new viral strains contained in the annual seasonal influenza vaccines. The supplemental application is expected to expedite the vaccine's licensing process. 

17th August 2009

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