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.
Age range
18 Years – 69 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.