Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, has announced that its dengue vaccine, the most clinically advanced to date, has reached the final stage of development.
The vaccine has entered Phase 3 studies, the last step before submission to the regulatory authorities to evaluate it for market authorisation.
The study is the first to use dengue vaccine doses produced with industrial-scale processes and is aimed at demonstrating that production of the vaccine at this level will meet consistency criteria required for market authorisation by regulatory authorities.
The vaccine targets all four virus serotypes, and has been evaluated in clinical studies (Phase 1, 2) in adults and children in the US, Asia and Latin America.
Clinical studies in adults and children are ongoing in Mexico, Colombia, Honduras, Puerto Rico, Peru, the Philippines, Vietnam, Singapore, Australia and Thailand.
