Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine

Butantan Institute

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Sanofi Trivalent Seasonal Influenza Vaccine; Biological: Butantan Institute Trivalent Seasonal Influenza Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03777163

FLU-07-IB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 632 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult, male or female, age 18 to 69 years (inclusive) at the time of enrollment;
• Provide written informed consent;
• Agrees to complete all study visits, procedures and contacts;

Exclusion criteria

• Chronic medical conditions such as psychiatric conditions, diabetes, hypertension or any other conditions that might place the subjects at high risk of adverse events. Study clinicians will use clinical judgment on a case-by-case basis to assess safety risks under this criterion;
• Clinically significant abnormalities on physical examination;
• Use of immunosuppressive medications such as systemic corticosteroids or chemotherapeutics, or immunosuppressive illness. It will be considered immunosuppressive dose of systemic corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days;
• Women who report being pregnant or have plans to become pregnant during the study period;
• Participation in research involving another investigational product within 30 days before planned date of first vaccination or anytime through the last study safety visit;
• Acute febrile illness (axilar temperature ≥ 37.8°C);
• Hypersensitivity to egg or chicken proteins;
• History of Guillain-Barre Syndrome;
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination;
• Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the previous 12 weeks);
• Alcohol abuse or drug addiction;
• Any vaccination within the previous 4 weeks;
• Seasonal influenza vaccination in the previous 6 months.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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632 participants in 2 patient groups

Butantan Trivalent Influenza Vaccine

Other group

Description:

Butantan Institute Trivalent Seasonal Influenza Vaccine (IB-TIV): 15 μg influenza A/H1N1 antigen + 15 μg influenza A/H3N2 antigen + 15 μg influenza B antigen Patients will receive one dose (0,5 ml) via intramuscular injection.

Treatment:

Biological: Butantan Institute Trivalent Seasonal Influenza Vaccine

Sanofi Trivalent Influenza Vaccine

Other group

Description:

Sanofi Trivalent Seasonal Influenza Vaccine (IB-TIV): 15 μg influenza A/H1N1 antigen + 15 μg influenza A/H3N2 antigen + 15 μg influenza B antigen Patients will receive one dose (0,5 ml) via intramuscular injection.

Treatment:

Biological: Sanofi Trivalent Seasonal Influenza Vaccine