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.
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Geometric Mean Titers of Hemaglutination Inhibition (HI) for each of the three vaccine components.
Timeframe: 21 days
Adverse events occurring over the immediate 30-minute post vaccination
Timeframe: 30-minute post vaccination
Number of participants with solicited local AE (erythema, swelling, induration, pain, tenderness, ecchymosis, pruritus) until 3 days post vaccination.
Timeframe: 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.
Timeframe: 3 days post vaccination
Number of participants with unsolicited adverse events up to 3 days after vaccination.
Timeframe: 3 days after vaccination.
All adverse reactions with severity graded 3/4 over the entire study period.
Timeframe: 180 days after vaccination.