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Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine
Sponsor: Butantan Institute
Summary
The overall aim of this study is to evaluate the safety and immunogenicity of Butantan Institute Trivalent Seasonal Influenza Vaccine in comparison with the Sanofi Trivalent Seasonal Influenza Vaccine.
Official title: Safety and Immunogenicity of the Butantan Institute Trivalent Seasonal Influenza Vaccine in Comparison With the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine in Brazilian Subjects.
Key Details
Gender
All
Age Range
18 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
632
Start Date
2019-04-22
Completion Date
2020-03-30
Last Updated
2026-05-11
Healthy Volunteers
Yes
Conditions
Interventions
Butantan Institute Trivalent Seasonal Influenza Vaccine
Butantan Institute and Pasteur-Mérieux (present, Sanofi Pasteur) established a technology transfer in 1999 for the production of a trivalent influenza vaccine of inactivated split-virion using embryonated eggs. The technology transfer followed a progressive approach from importing the finished product, to packaging and quality control test for release (1999), and, finally, to the first batch of influenza vaccine entirely produced by Butantan (2011). In 2013, the Butantan vaccine was registered by the Brazilian National Agency of Sanitary Surveillance (ANVISA).
Sanofi Trivalent Seasonal Influenza Vaccine
VAXIGRIP® was launched in 1968 and since then has been licensed in more than 100 countries and prequalified by WHO in 2011. Several clinical studies by Sanofi Pasteur have examined the safety and immunogenicity of Vaxigrip® in older children (8-10 years), adults (18-59 years), elderly (\> 60 years),11,12 children (six months to three years) 13 and pregnant women.
Locations (4)
Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
Centro de Referências para Imunobiológicos Especiais da Universidade Federal de São Paulo
São Paulo, São Paulo, Brazil
Centro de Pesquisas Clínicas do Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil