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Clinical evaluation strategies for a live attenuated tetravalent dengue vaccine.
Precioso, Alexander Roberto; Palacios, Ricardo; Thomé, Beatriz; Mondini, Gabriella; Braga, Patrícia; Kalil, Jorge.
Afiliação
  • Precioso AR; Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil; Pediatrics Department of the School of Medicine of University of Sao Paulo, São Paulo, Brazil. Electronic address: alexander.precioso@butantan.gov.br.
  • Palacios R; Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil.
  • Thomé B; Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil.
  • Mondini G; Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil.
  • Braga P; Division of the Clinical Trials and Pharmacovigilance, Butantan Institute, São Paulo, Brazil.
  • Kalil J; Butantan Institute, São Paulo, Brazil; Clinical Immunology and Allergy Division, University of São Paulo, São Paulo, Brazil.
Vaccine ; 33(50): 7121-5, 2015 Dec 10.
Article em En | MEDLINE | ID: mdl-26458796
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos como Assunto / Dengue / Vacinas contra Dengue Limite: Humans País/Região como assunto: America do sul / Brasil Idioma: En Revista: Vaccine Ano de publicação: 2015 Tipo de documento: Article País de publicação: Holanda
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos como Assunto / Dengue / Vacinas contra Dengue Limite: Humans País/Região como assunto: America do sul / Brasil Idioma: En Revista: Vaccine Ano de publicação: 2015 Tipo de documento: Article País de publicação: Holanda