SWIFTWATER, Pa.—Oct. 25 saw two clinical trial announcements from Sanofi Pasteur regarding its Fluzone influenza virus vaccine program—one in Phase III with an intradermal variety of Fluzone, and the other in Phase II/III action with the quadrivalent vaccine.
The intradermal news was the presentation of Phase III clinical trial results for the company's investigational Fluzone Intradermal vaccine candidate compared to Fluzone administered via the traditional intramuscular method. Earlier this year, Sanofi Pasteur announced that it had filed a Supplemental Biologics License Application with the U.S. Food and Drug Administration (FDA) for Fluzone Intradermal, which has been accepted for review by the FDA—with an action date anticipated in the first half of 2011. Compared to the licensed vaccine introduced intramuscularly (Fluzone IM), Fluzone Intradermal has a lower antigen content and injection volume.
The multicenter, active-controlled, modified double-blind Phase III trial was conducted in the United States during the 2008-2009 influenza season among 4,292 adults, 18 through 64 years of age. The Fluzone Intradermal vaccine was found to induce comparable immunologic responses to the licensed Fluzone IM vaccine. Systemic reactogenicity of Fluzone Intradermal was comparable to that of Fluzone IM in the study. Injection-site reactions were reported more frequently in participants given Fluzone Intradermal compared with those given Fluzone IM, as was expected given that the vaccine antigens were administered into the dermal space. Most of the reported injection-site and systemic reactions were of Grade 1 or Grade 2 in intensity and resolved in three to seven days without sequelae.
"The results from this large Phase III study in adults show that administration of influenza vaccine with an intradermal microinjection system may reduce the amount of antigen required for an immune response similar to that seen with Fluzone vaccine," says Dr. Geoffrey J. Gorse, professor of internal medicine in the Division of Infectious Diseases and Immunology at St. Louis University. "The reduced amount of antigen, smaller volume of vaccine administered and shorter needle associated with intradermal microinjection compared with traditional intramuscular injection are attractive attributes for healthcare providers and their patients that are likely to lead to increased acceptance of influenza vaccination and increase population coverage."
In other Fluzone clinical trial news, the company also noted Oct. 25 that following positive Phase II data related to its Fluzone Quadrivalent influenza virus vaccine, it will now conduct phase III trials.
The results came from a clinical trial of its investigational Fluzone Quadrivalent compared to the currently licensed Fluzone. In this study, quadrivalent inactivated influenza vaccine (QIV) containing two strains of type A (H1N1 and H3N2) and two strains of type B (one each from the Yamagata and Victoria lineages) was evaluated in comparison to two trivalent seasonal influenza vaccines (TIV), each containing the two strains of type A plus one of the two type B strains. The data indicated that the QIV vaccine was immunologically non-inferior to TIV for all strains and the safety profiles of QIV and TIV did not materially differ. Moreover, QIV induced responses to both B lineage strains simultaneously.
"Based on the data from this trial, Sanofi Pasteur plans to proceed with Phase III clinical trials of Fluzone Quadrivalent vaccine this fall," reports Wayne Pisano, president and CEO of Sanofi Pasteur. "We believe that Fluzone Quadrivalent vaccine could be an important vaccine for public health that may help reduce overall morbidity and mortality caused by influenza."
Since influenza B Victoria lineage re-emerged worldwide in 2001-2002, Pisano notes, both the Victoria and Yamagata lineages have circulated with varying prevalence, making it difficult to predict the next season's dominant lineage. Even in years where there was a good match, some influenza disease was caused by the B lineage omitted from the vaccine. This raised the hypothesis that the addition of a second B lineage strain to expand the licensed trivalent influenza vaccine to a quadrivalent vaccine could reduce influenza morbidity and mortality.
The intradermal news was the presentation of Phase III clinical trial results for the company's investigational Fluzone Intradermal vaccine candidate compared to Fluzone administered via the traditional intramuscular method. Earlier this year, Sanofi Pasteur announced that it had filed a Supplemental Biologics License Application with the U.S. Food and Drug Administration (FDA) for Fluzone Intradermal, which has been accepted for review by the FDA—with an action date anticipated in the first half of 2011. Compared to the licensed vaccine introduced intramuscularly (Fluzone IM), Fluzone Intradermal has a lower antigen content and injection volume.
The multicenter, active-controlled, modified double-blind Phase III trial was conducted in the United States during the 2008-2009 influenza season among 4,292 adults, 18 through 64 years of age. The Fluzone Intradermal vaccine was found to induce comparable immunologic responses to the licensed Fluzone IM vaccine. Systemic reactogenicity of Fluzone Intradermal was comparable to that of Fluzone IM in the study. Injection-site reactions were reported more frequently in participants given Fluzone Intradermal compared with those given Fluzone IM, as was expected given that the vaccine antigens were administered into the dermal space. Most of the reported injection-site and systemic reactions were of Grade 1 or Grade 2 in intensity and resolved in three to seven days without sequelae.
"The results from this large Phase III study in adults show that administration of influenza vaccine with an intradermal microinjection system may reduce the amount of antigen required for an immune response similar to that seen with Fluzone vaccine," says Dr. Geoffrey J. Gorse, professor of internal medicine in the Division of Infectious Diseases and Immunology at St. Louis University. "The reduced amount of antigen, smaller volume of vaccine administered and shorter needle associated with intradermal microinjection compared with traditional intramuscular injection are attractive attributes for healthcare providers and their patients that are likely to lead to increased acceptance of influenza vaccination and increase population coverage."
In other Fluzone clinical trial news, the company also noted Oct. 25 that following positive Phase II data related to its Fluzone Quadrivalent influenza virus vaccine, it will now conduct phase III trials.
The results came from a clinical trial of its investigational Fluzone Quadrivalent compared to the currently licensed Fluzone. In this study, quadrivalent inactivated influenza vaccine (QIV) containing two strains of type A (H1N1 and H3N2) and two strains of type B (one each from the Yamagata and Victoria lineages) was evaluated in comparison to two trivalent seasonal influenza vaccines (TIV), each containing the two strains of type A plus one of the two type B strains. The data indicated that the QIV vaccine was immunologically non-inferior to TIV for all strains and the safety profiles of QIV and TIV did not materially differ. Moreover, QIV induced responses to both B lineage strains simultaneously.
"Based on the data from this trial, Sanofi Pasteur plans to proceed with Phase III clinical trials of Fluzone Quadrivalent vaccine this fall," reports Wayne Pisano, president and CEO of Sanofi Pasteur. "We believe that Fluzone Quadrivalent vaccine could be an important vaccine for public health that may help reduce overall morbidity and mortality caused by influenza."
Since influenza B Victoria lineage re-emerged worldwide in 2001-2002, Pisano notes, both the Victoria and Yamagata lineages have circulated with varying prevalence, making it difficult to predict the next season's dominant lineage. Even in years where there was a good match, some influenza disease was caused by the B lineage omitted from the vaccine. This raised the hypothesis that the addition of a second B lineage strain to expand the licensed trivalent influenza vaccine to a quadrivalent vaccine could reduce influenza morbidity and mortality.
