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Presentation: Fluzone

Efficacy study of Fluzone® High-Dose vaccine compared with Fluzone® in Elderly Adults
• Randomized, modified double-blind, active controlled, multi-center trial
Primary Objective:
• Compare clinical efficacy of Fluzone® HD to Fluzone® in elderly adults, with respect to laboratory confirmed influenza, caused by any viral types/subtypes, associated with a protocol-defined Influenza Like Illness (ILI)
Primary Endpoint
• Occurrences of culture- or PCR-confirmed influenza (_14 days postvaccination) caused by any influenza viral types/subtypes, in association with a protocol-defined ILI.
Importance of FIM12
• FIM12 is the clinical study to prove effectiveness by performing surveillance for respiratory illness and testing for influenza
• A better influenza vaccine for the elderly would:
o Prevent more cases of influenza
o Prevent more cases of influenza complications, including hospitalizations & deaths
• If High Dose is superior, there is potential impact on public health

Why not download the full presentation and discover more about quality and collaboration in a large scale clinical trial for Influenza
• Coordinating several trial sites, and maintaining productivity, communication and mutual communication across the board
• Meeting the challenges of conducting a large scale clinical trial, and what solutions can be offered
• Different perspectives throughout the trial phases – how best to forge an effective relationship between all parties involved in the vaccine clinical trial process.
Janet Christoff, Clinical Study Manager, sanofi Pasteur- World Vaccine Congress WASHINGTON 2012


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