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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Immunogenicity of the Butantan Institute Trivalent Seasonal Influenza Vaccine in Comparison With the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine in Brazilian Subjects.

Conditions
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Influenza

Intervention / Treatment
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* Biological: Butantan Institute Trivalent Seasonal Influenza Vaccine
* Biological: Sanofi Trivalent Seasonal Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Butantan Trivalent Influenza Vaccine<br>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. | Biological: Butantan Institute Trivalent Seasonal Influenza Vaccine<br>* Butantan Institute and Pasteur-Mérieux (present, Sanofi Pasteur) established a technology transfer in 1999 for the production of a trivalent influenza vaccine of inactivated split-virion using embryonated eggs. The technology transfer followed a progressive approach from importing the finished product, to packaging and quality control test for release (1999), and, finally, to the first batch of influenza vaccine entirely produced by Butantan (2011). In 2013, the Butantan vaccine was registered by the Brazilian National Agency of Sanitary Surveillance (ANVISA).<br>|
| Other: Sanofi Trivalent Influenza Vaccine<br>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. | Biological: Sanofi Trivalent Seasonal Influenza Vaccine<br>* VAXIGRIP® was launched in 1968 and since then has been licensed in more than 100 countries and prequalified by WHO in 2011. Several clinical studies by Sanofi Pasteur have examined the safety and immunogenicity of Vaxigrip® in older children (8-10 years), adults (18-59 years), elderly (> 60 years),11,12 children (six months to three years) 13 and pregnant women.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers of Hemaglutination Inhibition (HI) for each of the three vaccine components. | HI titers will be determined in serum samples collected before vaccination and 21 days after vaccination from all the subjects. | 21 days | 
| Adverse events occurring over the immediate 30-minute post vaccination | Immediate Reactogenicity | 30-minute post vaccination | 
| Number of participants with solicited local AE (erythema, swelling, induration, pain, tenderness, ecchymosis, pruritus) until 3 days post vaccination. | Solicited Local Adverse Events | 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. | Solicited Systemic Adverse Events | 3 days post vaccination | 
| Number of participants with unsolicited adverse events up to 3 days after vaccination. | Unsolicited Adverse Events | 3 days after vaccination. | 
| All adverse reactions with severity graded 3/4 over the entire study period. | Adverse Reactions with severity graded 3/4 | 180 days after vaccination. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Immunization, Safety, Immunogenicity