Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Adverse events in the first 3 days post vaccination (Safety)
研究概览
简要总结
Prospective cohort study to evaluate the safety and immunogenicity of the Butantan Influenza vaccine (Fragmented and Inactivated) among healthy adults with 18 to 59 years of age and elderly older than 60 years of age.
详细描述
Prospective cohort study to assess safety of one dose of theButantan Influenza vaccine (Fragmented and Inactivated) in the first 3 days after vaccination and its immunogenicity 21 days after vaccination among healthy adults with 18 to 59 years of age and elderly older than 60 years of age..
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults, male or female aged 18 to 59
- •Elderly aged 60 years completed and above
- •To be available to participate in the study throughout its duration (approximately 21 days)
- •To have medical indication to be vaccinated against influenza
- •To demonstrate intention to participate in the study, as documented by signature in the study´s informed consent form.
排除标准
- •Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as clinical history and/or physical examination (except hypertension under control among the elderly)
- •Compromised immune system diseases including: HIV, diabetes mellitus, cancer (except basal cell carcinoma) and autoimmune diseases
- •Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements
- •Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history
- •Known systemic hypersensitivity to eggs or to any component of the vaccine
- •History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination
结局指标
主要结局
Adverse events in the first 3 days post vaccination (Safety)
时间窗: Three days
Solicited and unsolicited local and systemic adverse reactions reported by the participants until Day 3 after vaccination.
Antibody response to each of the vaccine strains 21 days post vaccination (Immunogenicity)
时间窗: 21 days
Antibody response to each of the vaccine´s strains as measured by: * % seroconversion and/or * increase in the geometric mean of hemagglutination inhibition (HAI) titers and/or * % seroprotection.
次要结局
未报告次要终点