Status:
COMPLETED
Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine
Lead Sponsor:
Butantan Institute
Conditions:
Influenza
Eligibility:
All Genders
18-69 years
Phase:
PHASE4
Brief Summary
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
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 Infl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
632 Patients enrolled
Trial Details
Trial ID
NCT03777163
Start Date
April 22 2019
End Date
March 30 2020
Last Update
February 15 2024
Active Locations (4)
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1
Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil, 14049900
2
Centro de Referências para Imunobiológicos Especiais da Universidade Federal de São Paulo
São Paulo, São Paulo, Brazil, 01220200
3
Centro de Pesquisas Clínicas do Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil, 05403 000
4
Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil, 05403-000