Prospective study to evaluate the safety and immunogenicity of Butantan Influenza seasonal vaccine.
Prospective cohort study to evaluate safety (three days post vaccination) and immunogenicity (measured 21 days post vaccination) of one dose of Butantan Influenza vaccine.
Study Type
OBSERVATIONAL
Enrollment
63
Butantan Fragmented Inactivated Trivalent Influenza Vaccine
Centro de Pesquisas Clínicas do Instituto da Criança do Hospital das Clínicas
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
Safety assessed by unsolicited local and systemic adverse reactions
Vaccine safety assessed by unsolicited local and systemic adverse reactions up to 3 days post vaccination
Time frame: 3 days
Antibody response to each of the vaccine´s strains (Immunogenicity)
Antibody response to each of the vaccine´s strains as measured by % seroconversion, and/or increase in the geometric mean of hemagglutination inhibition (HAI) titers and/or % seroprotection.
Time frame: 21 days
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