Efficacy study of Fluzone® High-Dose vaccine compared with Fluzone® in Elderly Adults

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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

To download the full presentation, click here >
For more information about the topics discussed, please click here >

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