Persistence Study of Immune Response After Vaccination With Influenza Vaccine in Healthy Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months
研究概览
简要总结
This clinical study will be performed in subjects aged 12-60 years old enrolled in NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the immune response of influenza vaccine up to 24 months after vaccination.
详细描述
Subjects were previously vaccinated at 12 to 60 years of age with 2010 seasonal influenza vaccine.The persistence phase starts 24 months after the primary vaccination and blood samples will be taken at 6, 12, 18 and 24 months after primary vaccination. Subjects whose antibody titer less than 1:40 at 6 months after primary vaccination will receive a booster dose of influenza vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 12-60 years old
- •male or non-pregnant female
- •volunteers received 2010 seasonal influenza vaccine
- •clinically healthy as determined by: medical history inquiring and physical examination
- •provide written informed consents before joining the trial
排除标准
- •without history of 2010 seasonal influenza vaccine administration,
- •allergic to any ingredient of vaccine,
- •autoimmune disease or immunodeficiency,
- •severe adverse reaction after vaccination, such as allergies, hives, breathing difficulties, angioedema or abdominal pain,
- •severe acute and chronic diseases
- •axillary temperature over 37.0℃ at the time of vaccination.
结局指标
主要结局
change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months
时间窗: 6，12，18，24 months after the primary vaccination
Persistence of antibodies in all subjects with respect to components of the investigational vaccine - month 6，12，18，24
次要结局
未报告次要终点
研究者
Wu Jiang
Department of Immunization & Prevention, Beijing Centers for Disease Control and Prevention
Centers for Disease Control and Prevention, China