Sanofi Pasteur said its dengue vaccine is in the final leg of clinical trials in India and would register the product in 2015 in countries where it is highly prevalent.
“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 – Sanofi Pasteur.
Once registered, it becomes the world’s first dengue vaccine. "We have competed the Phase II study amongst 189 adult subjects across five sites in India, namely – Delhi, Ludhiana, Bangalore, Pune and Kolkata,” Barth told the BusinessLine.
Sanofi Pasteur’s dengue vaccine was conducted on 40,000 volunteers in its phase I and II trials so far. But it is mandatory to conduct trials in India to get registration, said the company.
According to Indian Health Ministry, over 13,900 cases were reported till September this year. The vector-borne disease that is transmitted by mosquitoes has replaced malaria that was prevalent during the 1970s.
Sanofi Pasteur would make the vaccine available in India and participates in the country’s comprehensive vaccination programme to meet the World Health Organsiaiton’s objective of reducing dengue mortality by 50% and morbidity by 25% by 2020, he told the Businessline.