Prospective cohort study to evaluate the safety and immunogenicity of the Butantan Influenza vaccine (Fragmented and Inactivated) among healthy adults with 18 to 59 years of age and elderly older than 60 years of age.
Prospective cohort study to assess safety of one dose of theButantan Influenza vaccine (Fragmented and Inactivated) in the first 3 days after vaccination and its immunogenicity 21 days after vaccination among healthy adults with 18 to 59 years of age and elderly older than 60 years of age..
Study Type
OBSERVATIONAL
Enrollment
120
Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Adverse events in the first 3 days post vaccination (Safety)
Solicited and unsolicited local and systemic adverse reactions reported by the participants until Day 3 after vaccination.
Time frame: Three days
Antibody response to each of the vaccine strains 21 days post vaccination (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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.