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Sanofi Pasteur Presents Additional Data on Investigational Quadrivalent Influenza Vaccine
Date:10/21/2011

oth Victoria and Yamagata lineages have circulated with varying prevalence, making it difficult to predict the next season's dominant lineage. Even in years when there was a good match to one B lineage strain, some influenza disease was caused by the other B lineage omitted from the vaccine. This led to the addition of a second B lineage strain in a quadrivalent formulation which may reduce influenza morbidity and mortality.

"The clinical significance of influenza B, the second most common cause of influenza-related complications and death after H3N2, is often overlooked," said Greenberg. "The results of our investigational studies to date continue to suggest that QIV has the potential to be a useful alternative to currently licensed influenza vaccines by including both B lineages that have been in circulation for the past decade. Thus, Sanofi Pasteur is continuing its clinical development program for this new vaccine which we believe will offer public health benefits." 

Study Design The study objectives included demonstration of non-inferiority of antibody responses to QIV compared with TIV, as assessed by geometric mean titer (GMT) ratios and seroconversion rates for each of the four virus strains among people age 65 years and older. Additional objectives of the study were to demonstrate superiority of antibody responses 21 days post-vaccination to each B strain in QIV compared with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates among the study participants.

In the double-blind, active-controlled, multicenter study, 675 healthy people 65 years of age and older were randomized 1:1:1 to receive one intramuscular dose of 2010-2011 licensed TIV (Fluzone vaccine, containing B/Brisbane/60/2008) [Victoria lineage]), investigational TIV (containing B/Florida/04/2006) [Yamagata lineage]) or QIV (containing both B strains). All three vaccines contained the same
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