Sanofi Pasteur has claimed 60% success in its dengue vaccine clinical trials conducted in Latin America on 20,869 children aged between 9 and 16.
In a paper published in the New England Journal of Medicine, the pharma giant said its analysis showed that 3 doses of the vaccine administered to children aged 9-16 years gave a 95.5% protection against severe dengue, while an 80.3% reduction was observed in hospitalisation risk during the trial. Every year, about 5 lakh people are hospitalised with dengue worldwide.
The analysis and results of the clinical trials were presented at the annual meeting of the American Society of Tropical Medicine and Hygiene. “Until now, we were only able to provide supportive care for patients with dengue. On the strength of the outcome of this phase III efficacy study, we hope this will become an effective preventive measure against dengue,” said Rivaldo Cunha, associate professor of Medicine, Universidade de Mato Grosso do Sul, Brazil and lead author of the study.
The clinical trials were conducted in dengue endemic areas of Brazil, Columbia, mexico, Honduras and Puerto Rico in Latin America, said the study.
The company said it would file for approval of the vaccine in the endemic areas, including India next year. In India, the company seeks to conduct the third phase of clinical trial and seek registration of the product.
“We have recently completed the Phase II study and are planning to conduct a Phase III study in India, which is a safety and immunogenicity study in a large age group,” said Stephan Barth, India Head of Sanofi Pasteur.
The company said it has completed so far the Phase II amongst 189 adults in five cities – Delhi, Ludhiana, Bangalore, Pune and Kolkata, Barth told the media.
According to Indian Health Ministry, over 13,900 cases were reported till September, 2014. The vector-borne disease has virtually replaced the erstwhile malaria of the 70s in the country.
The World Health Organization (WHO) has set an objective of reducing dengue mortality by 50% and morbidity by 25% by 2020.