Sanofi Pasteur has successfully completed phase 3 clinical efficacy study on dengue vaccine and is expecting to launch it in the market by next year.

Vaccine division of Sanofi Pasteur has announced the publication of the detailed results of the final phase III clinical efficacy study in Latin America in The New England Journal of Medicine.

According to its report, overall efficacy against any symptomatic dengue disease is 60.8 per cent in children and adolescents 9-16 years old who received three doses of the vaccine. Analyses showed a 95.5 per cent protection against severe dengue and an 80.3 per cent reduction in the risk of hospitalisation during the study. The results of this second phase III efficacy study confirm the high efficacy against severe dengue and the reduction in hospitalisation observed during the 25-month active surveillance period of the first phase III efficacy study conducted in Asia, highlighting the consistency of the results across the world.

Safety analyses (solicited reactions, unsolicited events and Serious Adverse Events) during the study showed similar reporting rates between the vaccine and control groups and are consistent with the favourable safety profile observed during the 25-month active surveillance period of the previous efficacy study conducted in Asia. The full data of the Latin American study are also presented at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting, 2-6 November 2014.

Sanofi Pasteur’s phase III efficacy clinical study programme for its dengue vaccine candidate is conducted in over 31,000 participants across 10 endemic countries in Asia and Latin America. Sanofi Pasteur will file for registration of its vaccine candidate and, subject to regulatory approval; the world’s first dengue vaccine could be available in the second half of 2015.

“We plan to submit the vaccine for licensure in 2015 in endemic countries where dengue is a public health priority. Our goal is to help meet the WHO’s objectives to reduce dengue mortality by 50 per cent and morbidity by 25 per cent by 2020,” said Olivier Charmeil, president and chief executive officer, of Sanofi Pasteur.

Dengue is a threat to over 2.5 billion people, nearly half the world’s population, and is a pressing public health priority in over 100 countries in the Americas and in Asia. Every year, an estimated 500,000 people, including children, are hospitalised due to severe dengue, which puts a huge strain on health care systems particularly during outbreaks.