Innovative strategies and methods for the implementation of Phase IIIb efficacy trials

In Regulation and Policy by Freya SmaleLeave a Comment

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Tina Washington, Senior Clinical Trial Manager, sanofi pasteur joined us the World Vaccine Congress Washington 2012 to review the innovative strategies and methods being employed in the implementation of 2 large Fluzone HD trials. The background of the Fluzone HD Program can be summed up as follows:

· High dose trivalent inactivated influenza vaccine

· Phase IIIb efficacy trial for a post-marketing commitment to the accelerated approval of Fluzone High-Dose

· FIM07- 3yrs, 33k subjects

     o 1 of 3 years completed

     o CBER agreed to postpone year 2 of study due to low attack rate in year 1 and pending post pandemic year

· FIM12- 2 yrs, 30k subjects

     o Broader illness definition to trigger an increase in NP swab rate

The main aim of the FIM trial methodology philosophy is to make sure everyone involved knows that this is not a typical flu trial. The key to success has been identified as the operational advisory panel. The panel was a key contributor to the success of the trial. Find out how by downloading the full presentation here >

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