Safety and Immunogenicity of the Butantan Institute Trivalent Seasonal Influenza Vaccine in Comparison With the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine in Brazilian Subjects.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 632
- 试验地点
- 8
- 主要终点
- Number of participants with solicited local AE (erythema, swelling, induration, pain, tenderness, ecchymosis, pruritus) until 3 days post vaccination.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Sanofi Trivalent Influenza Vaccine
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.
干预措施: Sanofi Trivalent Seasonal Influenza Vaccine (Biological)
Butantan Trivalent Influenza Vaccine
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.
干预措施: Butantan Institute Trivalent Seasonal Influenza Vaccine (Biological)
结局指标
主要结局
Number of participants with solicited local AE (erythema, swelling, induration, pain, tenderness, ecchymosis, pruritus) until 3 days post vaccination.
时间窗: 3 days post vaccination
Solicited Local Adverse Events
Number of participants with unsolicited adverse events up to 3 days after vaccination.
时间窗: 3 days after vaccination.
Unsolicited Adverse Events
All adverse reactions with severity graded 3/4 over the entire study period.
时间窗: 180 days after vaccination.
Adverse Reactions with severity graded 3/4
Adverse events occurring over the immediate 30-minute post vaccination
时间窗: 30-minute post vaccination
Immediate Reactogenicity
Number of participants with solicited systemic AEs (fever, fatigue, malaise, myalgia, arthralgia, chills, nausea, vomiting, and headache) until 3 days post vaccination.
时间窗: 3 days post vaccination
Solicited Systemic Adverse Events
Geometric Mean Titers of Hemaglutination Inhibition (HI) for each of the three vaccine components.
时间窗: 21 days
HI titers will be determined in serum samples collected before vaccination and 21 days after vaccination from all the subjects.
次要结局
未报告次要终点