Efficacy study of FluzoneÂ® High-Dose vaccine compared with FluzoneÂ® in Elderly Adults
Â· Randomized, modified double-blind, active controlled, multi-center trial
Â· Compare clinical efficacy of FluzoneÂ® HD to FluzoneÂ® in elderly adults, with respect to laboratory confirmed influenza, caused by any viral types/subtypes, associated with a protocol-defined Influenza Like Illness (ILI)
Â· 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
Â· FIM12 is the clinical study to prove effectiveness by performing surveillance for respiratory illness and testing for influenza
Â· A better influenza vaccine for the elderly would:
o Prevent more cases of influenza
o Prevent more cases of influenza complications, including hospitalizations & deaths
Â· 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
Â· Coordinating several trial sites, and maintaining productivity, communication and mutual communication across the board
Â· Meeting the challenges of conducting a large scale clinical trial, and what solutions can be offered
Â· 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