Clinical trial NCT03777163: Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine
Official title: Safety and Immunogenicity of the Butantan Institute Trivalent Seasonal Influenza Vaccine in Comparison With the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine in Brazilian Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Vaccine
Immunization
Safety
Immunogenicity
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
First posted: 2018-12-17
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean Titers of Hemaglutination Inhibition (HI) for each of the three vaccine components.
timeFrame: 21 days
measure: Adverse events occurring over the immediate 30-minute post vaccination
timeFrame: 30-minute post vaccination
measure: Number of participants with solicited local AE (erythema, swelling, induration, pain, tenderness, ecchymosis, pruritus) until 3 days post vaccination.
timeFrame: 3 days post vaccination
measure: 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
measure: Number of participants with unsolicited adverse events up to 3 days after vaccination.
timeFrame: 3 days after vaccination.
measure: All adverse reactions with severity graded 3/4 over the entire study period.
timeFrame: 180 days after vaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Centro de Referências para Imunobiológicos Especiais da Universidade Federal de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Centro de Pesquisas Clínicas do Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: Instituto butantan
name: Alexander Precioso, MD, PhD
role: STUDY_DIRECTOR
References: