- First available data demonstrated a 56% reduction of dengue disease cases in a study of more than 10,000 volunteers from Asia
- Initial safety data are consistent with the good safety profile observed in previous studies
About the Phase III clinical study conducted in Asia The Phase III clinical study conducted in Asia is a randomized, observer-blind, placebo-controlled multicenter trial. A total of 10,275 children aged 2 to 14 years from dengue endemic areas of Indonesia, Malaysia, the Philippines, Thailand and Vietnam participated in the study from 2011-2013 and were randomized to either receive three injections of the dengue vaccine or a placebo (2 to 1 ratio) at 6-month intervals. The primary endpoint was measured by the number of symptomatic virologically-confirmed dengue cases caused by any serotype. The study will continue with a long term follow up of the population. For more information about the clinical study: http://www.clinicaltrials.gov/ct2/show/NCT01373281?term=CYD14&rank=1.About Sanofi Pasteur's dengue vaccine clinical program Sanofi Pasteur has been working on a dengue vaccine for more than 20 years. The company's goal is to provide a safe and effective dengue vaccine accessible in all regions of the world where dengue is a public health issue. Over 40,000 volunteers are participating in the Sanofi Pasteur dengue vaccine clinical study program (Phase I, II and III). Sanofi Pasteur's dengue vaccine candidate is in Phase III clinical studies. It is the most clinically and industrially advanced vaccine candidate in development and the first dengue vaccine in advance development. The two, pivotal Phase III efficacy studies involve more than 31,000 volunteers from Asia (Indonesia, Malaysia, the Philippines, Thailand and Vietnam) and Latin America (Brazil, Columbia, Honduras, Mexico and Puerto Rico). The Phase III evaluations provide pivotal data on efficacy, safety, and immunogenicity of the vaccine candidate in a broad population and different epidemiological environments and assess the potential impact of the vaccine on the disease burden. About Dengue Dengue is a threat to nearly half of the world's population. Currently, there is no specific treatment available for dengue. It is a health priority in many countries of Latin America and Asia where epidemics occur regularly. The WHO estimates up to 100 million infections per year but the overall number of people infected with dengue globally is not fully known. 1 The WHO has set the goal of estimating the true public health burden of dengue by 2015. 2 Dengue is underreported because the disease is often misdiagnosed due to a large spectrum of clinical symptoms from mild non-specific illness to life threatening complications and because of the limitations of the surveillance systems. Each year, 500,000 people, including children, are affected with dengue hemorrhagic fever (DHF), the severe form of the disease. DHF is a leading cause of hospitalization, placing tremendous pressure on health systems and straining medical resources resulting in significant economic and social impact. Timely access to appropriate health care is critical to reduce the risk of mortality in case of severe dengue. The WHO has set the target to reduce dengue mortality by 50% and reduce morbidity by 25% by 2020. 2 Additional information, photos and videos about Sanofi Pasteur's dengue vaccine candidate are available on the web at http://www.dengue.info About Sanofi Sanofi, a global 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, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). Sanofi Pasteur, the vaccines division of Sanofi, provides more than one 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: www.sanofipasteur.com or www.sanofipasteur.us References
- World Health Organization (WHO). Dengue guidelines for diagnosis, treatment, prevention and control. Available at: http://www.who.int/tdr/publications/documents/dengue-diagnosis.pdf. Published 2009. Accessed March 24, 2013.
- World Health Organization (WHO). Global strategy for dengue prevention control: 2012-2020. Available at: http://reliefweb.int/sites/reliefweb.int/files/resources/9789241504034_eng.pdf. Published 2012. Accessed April 3, 2014
- World Health Organization (WHO). Antiviral research and development against dengue virus. Available at: http://www.who.int/tdr/research/ntd/dengue/dengue_full_length_report.pdf. Accessed March 24, 2013.
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