Evaluation Aof Safety and Immunogenicity of Non-adjuvanted Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants, Produced by Butantan Institute
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,152
- 试验地点
- 1
- 主要终点
- Antibody titers of 1:40 or more for influenza A pandemic (H1N1)
研究概览
简要总结
The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised disease, elderly and pregnants. The primary immunological endpoint is to analyze the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21 days after vaccination. Volunteers will be recruited based on inclusion and exclusion criteria. Vaccine composition is: 15 micrograms of split inactivated virus (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is safe and immunogenic in the volunteers recruited.
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
- 6 Months 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers able to understand and agree to participate in the study.
排除标准
- •Have egg allergy
- •Have past history of allergy to seasonal influenza vaccine
- •Have received another inactivated vaccine within the prior 2 weeks or live vaccine in the past four weeks to his/her participation in the study
- •Acute infectious disease during seven days prior vaccination
- •Confirmed prior infection by pandemic influenza A (H1N1)
- •Have participated in another clinical trial in the last 6 months
- •Any other condition identified by the principal investigators which is considered not safe for enrollment of the volunteer.
结局指标
主要结局
Antibody titers of 1:40 or more for influenza A pandemic (H1N1)
时间窗: 21 days after vaccination
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
次要结局
- Safety of the vaccine(21 days after vaccination)