Sanofi Pasteur Presents Additional Data on Investigational Quadrivalent Influenza Vaccine

Addition of fourth strain to influenza vaccine intended to address potential for a mismatch between strains selected for vaccine and circulating influenza viruses

SWIFTWATER, PA, USA | October 21, 2011 | Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN - News), announced today the results of a new study evaluating the immunogenicity and safety of an investigational quadrivalent inactivated influenza vaccine (QIV) among adults 65 years of age and older. Currently licensed influenza vaccines target only three influenza virus strains anticipated to circulate in a given year. The data were presented at the 49th Annual Meeting of the Infectious Diseases Society of America (IDSA) on October 21, 2011.

This study affirms the findings of a previous study on QIV presented last year at IDSA in adults 18 years of age and older. The results of the Phase II study indicated that the addition of an alternate-lineage B strain does not adversely affect the safety or immunogenicity profile of QIV compared to the currently licensed trivalent inactivated vaccine (TIV), Fluzone® (Influenza Virus Vaccine). In addition to the data in elderly adults presented today, a Phase III study in children 6 months through 18 years of age also is underway with data anticipated later this year.

"The QIV development program supports Sanofi Pasteur's strategy to develop new vaccine options tailored to individual segments of the population to better support health-care providers in the public health fight to reduce overall morbidity and mortality caused by influenza," said David Greenberg, M.D., Senior Director U.S. Scientific and Medical Affairs, Sanofi Pasteur.

Currently, the annual influenza vaccine formulation targets the three influenza virus strains anticipated to circulate in a given year. This annual vaccine formulation includes two A strains, A(H1N1) and A(H3N2), and one of the two currently circulating B strains. However, since influenza B Victoria lineage re-emerged worldwide in 2001-2002, both 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 H1N1 (A/California/07/2009) and H3N2 (A/Victoria/210/2009) strains.

Safety was monitored for 21 days after vaccination. Blood specimens for immunogenicity (hemagglutination inhibition [HI assay]) were collected pre- and 21 days post-vaccination.

Immunogenicity and Safety Data

In this investigational study, the immune responses to QIV were non-inferior to both of the control TIVs with respect to all four strains contained in the vaccine as measured by GMTs. For seroconversion rates, immune responses to QIV were non-inferior to those of the control TIVs with respect to all strains, except A/H1N1.

Superiority was assessed by comparing antibody responses to each B strain in QIV with those induced by the TIV that did not contain the corresponding B strain. For GMTs, superiority was demonstrated for the B/Florida (B2) strain in QIV, but not for B/Brisbane (B1). Although superiority of GMT for B/Brisbane was not achieved, the GMT was numerically superior and statistically non-inferior in QIV compared with the investigational TIV.

For all groups in this investigational study, the most frequently reported solicited injection-site reaction was pain. The most frequently reported solicited systemic reactions were myalgia, headache and malaise. Three serious adverse events were reported in the study, but did not occur among QIV recipients and were not considered related to the study vaccine.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT:SAN - News) and in New York (NYSE:SNY - News).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: or

SOURCE: Sanofi

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