Sanofi Pasteur Announces Final Results of U.S. Clinical Trials of Influenza A (H1N1) Vaccine in Adults and Children
Final data confirm immunogenicity, safety profile
Single dose provides robust immune response in adults; two doses provide robust immune response in children 6 months through 9 years
Nov 11, 2009
Swiftwater, Pa (United States) – November 11, 2009 – Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today the final analyses of data from clinical trials of the U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine in adults and children.
The data confirm the immunogenicity and safety profile of the vaccine, with no serious vaccine- related adverse events reported during the 42 days of follow-up in the two trials.
“These are extremely important data,” said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur, “because they once again make clear not only the immunogenicity of the Influenza A (H1N1) 2009 Monovalent Vaccine manufactured by Sanofi Pasteur, but also the fact that this vaccine has a safety profile similar to that typically observed with seasonal influenza vaccine in all age groups studied.”
The trials confirm that one dose of Influenza A (H1N1) 2009 Monovalent Vaccine induces a robust antibody response in adults – but two doses of vaccine are needed to assure a robust antibody response in children 9 years of age and younger. The two-dose regimen for these younger children is similar to the recommendations for seasonal influenza immunization in this age group.
About the Trial
The randomized, placebo-controlled, multicenter trials were conducted by Sanofi Pasteur to determine the immunogenicity and safety of the vaccine, given in two doses, with the second dose administered 21 days following the first dose. Immunogenicity was measured at day 21, just prior to administration of the second dose, and again at day 42.
The adult trial was conducted in 849 individuals divided into two age cohorts: 18 through 64 years of age; and 65 years of age and older. Study participants in each age cohort were randomized to four treatment groups. Three groups received a 0.5 mL injection of non-adjuvanted vaccine formulated to contain 7.5, 15 or 30 mcg of hemagglutinin (HA) antigen. The fourth group received a placebo control (ClinicalTrials.gov registration number NCT00953524).
In the pediatric trial, 474 children were enrolled in two age cohorts: 6 months through 35 months of age; and 3 years through 9 years of age. The trial evaluated two vaccine formulations, 7.5 mcg and 15 mcg of HA antigen in each of two cohorts, with a third group receiving a placebo (ClinicalTrials.gov registration number NCT00952419).
At Day 42, 21 days following a second 7.5 mcg dose of Influenza A (H1N1) 2009 Monovalent Vaccine, seroprotection (defined as an antibody titer of 1:40 or greater) was achieved in 92 percent of children 6 months through 35 months of age; and following a second 15 mcg dose of the vaccine, seroprotection was achieved in 99 percent of children 3 through 9 years of age, 99 percent of adults 18 through 64 years of age and in 95 percent of adults age 65 and older.
Sanofi Pasteur previously reported interim data showing that an immune response considered seroprotective was achieved following one 15 mcg dose of the vaccine in 50 percent of children 6 months through 35 months of age, 76 percent of children 3 through 9 years of age, 98 percent of adults 18 through 64 years of age and 92 percent of adults age 65 and older.
A rise in antibody titers lower than 1:40 following vaccination may minimize the occurrence of disease and its consequences but is not considered seroprotective.
The data from these clinical trials provide additional information to guide recommendations on the optimal dosage, number of doses and schedule.
No serious vaccine-related adverse events were reported during the trial. Adverse event monitoring will continue for six months after administration of the second vaccine dose. Solicited systemic and local reactions reported were similar to those observed in other studies of seasonal trivalent inactivated influenza vaccine administered to persons in comparable age groups.
About Influenza A (H1N1) 2009 Monovalent Vaccine
The U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine manufactured by Sanofi Pasteur is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older
against influenza disease caused by pandemic (H1N1) 2009 virus. Influenza A (H1N1) 2009 Monovalent
Vaccine was licensed by the U.S. Food and Drug Administration on September 15 as a monovalent strain change to Sanofi Pasteur’s licensed seasonal influenza vaccine.
The Influenza A (H1N1) 2009 Monovalent Vaccine is manufactured by the same process as Sanofi Pasteur’s seasonal trivalent influenza virus vaccine licensed in the U.S. Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v–like virus. Influenza A (H1N1) 2009 Monovalent Vaccine is licensed for single-dose presentations in syringes and vials and in multi-dose vials. There is no preservative used in the single-dose presentations. Multi-dose vials contain a preservative.
Safety Information for Influenza A (H1N1) 2009 Monovalent Vaccine
Influenza vaccine should not be administered to anyone with a known severe hypersensitivity to egg proteins, any vaccine component or life-threatening reactions after previous administration of any influenza vaccine. Recurrence of Guillain-Barré syndrome (GBS) has been temporally associated with the administration of influenza vaccine. The decision to give Influenza A (H1N1) 2009 Monovalent Vaccine to individuals who have a prior history of GBS should be based on careful consideration of the potential benefits and risks. Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals.
Before administering Influenza A (H1N1) 2009 Monovalent Vaccine, please see full U.S. Prescribing Information at www.vaccineplace.com/products.
About Influenza Vaccine Production at Sanofi Pasteur
Sanofi Pasteur operates influenza vaccine production facilities in Val de Reuil, France and in Swiftwater, Pa. (U.S.). All Sanofi Pasteur influenza vaccine facilities have been designed and built to be able to switch from seasonal influenza vaccine production to pandemic influenza vaccine production.
Sanofi Pasteur produces approximately 40 percent of the influenza vaccines distributed worldwide and more than 45 percent of the influenza vaccines distributed in the U.S. for the 2008-2009 influenza season. More information about Sanofi Pasteur’s pandemic preparedness efforts can be found at www.pandemic.influenza.com.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2008, 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: http://www.sanofipasteur.com or www.sanofipasteur.us.
This project has been funded with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100200900121C. The views expressed do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices or organizations imply endorsement by the U.S. Government.
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
For further information: US Media Relations Donna Cary T. +1-570-957-0717 firstname.lastname@example.org www.sanofipasteur.us