| Literature DB >> 26458796 |
Alexander Roberto Precioso1, Ricardo Palacios2, Beatriz Thomé2, Gabriella Mondini2, Patrícia Braga2, Jorge Kalil3.
Abstract
Butantan Institute is a public Brazilian biomedical research-manufacturer center affiliated to the São Paulo State Secretary of Health. Currently, Butantan is one of the main public producers of vaccines, antivenoms, and antitoxins in Latin America. The partnership between Butantan and the National Institutes of Health (NIH) of the United Sates has been one of the longest and most successful partnerships in the development and manufacturing of new vaccines. Recently, Butantan Institute has developed and manufactured a lyophilized tetravalent live attenuated dengue vaccine with the four dengue viruses attenuated and licensed from the Laboratory of Infectious Diseases at The National Institutes of Allergy and Infectious Diseases (LID/NIAID/NIH). The objective of this paper is to describe the clinical evaluation strategies of a live attenuated tetravalent dengue vaccine (Butantan-DV) developed and manufactured by Butantan Institute. These clinical strategies will be used to evaluate the Butantan-DV Phase III trial to support the Butantan-DV licensure for protection against any symptomatic dengue caused by any serotype in people aged 2 to 59 years.Entities:
Keywords: Butantan Institute; Clinical trial; Tetravalent dengue vaccine
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Year: 2015 PMID： 26458796 DOI： 10.1016/j.vaccine.2015.09.105
Source DB: PubMed Journal: Vaccine ISSN： 0264-410X Impact factor: 3.641