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.
To detemine whether immunogenicity elicited by a single-dose Butantan Institute Trivalent Seasonal Influenza Vaccine is not inferior to that elicited by a single dose of Sanofi Trivalent Seasonal Influenza Vaccine in adult and elderly populations measured by HI GMT for the three vaccine components 21 days post-immunization. To describe the safety profile of Butantan Institute Trivalent Seasonal Influenza Vaccine and Sanofi Trivalent Seasonal Influenza Vaccine after a single dose in adult and elderly populations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
632
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).
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.
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
Geometric Mean Titers of Hemaglutination Inhibition (HI) for each of the three vaccine components.
HI titers will be determined in serum samples collected before vaccination and 21 days after vaccination from all the subjects.
Time frame: 21 days
Adverse events occurring over the immediate 30-minute post vaccination
Immediate Reactogenicity
Time frame: 30-minute post vaccination
Number of participants with solicited local AE (erythema, swelling, induration, pain, tenderness, ecchymosis, pruritus) until 3 days post vaccination.
Solicited Local Adverse Events
Time frame: 3 days post vaccination
Number of participants with solicited systemic AEs (fever, fatigue, malaise, myalgia, arthralgia, chills, nausea, vomiting, and headache) until 3 days post vaccination.
Solicited Systemic Adverse Events
Time frame: 3 days post vaccination
Number of participants with unsolicited adverse events up to 3 days after vaccination.
Unsolicited Adverse Events
Time frame: 3 days after vaccination.
All adverse reactions with severity graded 3/4 over the entire study period.
Adverse Reactions with severity graded 3/4
Time frame: 180 days after vaccination.
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Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil