Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Seroconversion rate
研究概览
简要总结
Evaluation of immunogenicity and safety of the subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease recruited to receive the schedule of three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .
详细描述
The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease were recruited to receive three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively.
Blood samples were collected before the first dose, 28 days after the second dose, before the third dose, 28 days after the third dose and 6 months after the third dose, respectively.
Any local or systemic adverse events that occurred within 21/28 days after vaccination will be recorded.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Seroconversion rate
时间窗: 28 days after the 3th dose (Day 139)
The rate of seroconversion against coronavirus after the third dose of booster immunization
Neutralizing antibody level
时间窗: 6 months after the 3th dose (Day 291)
Neutralizing antibody GMT against coronavirus after the 3th dose
Baseline neutralizing antibody level
时间窗: Before vaccination (Day 0)
Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
次要结局
- Adverse events rate(0-21/28 days following vaccinations)
- Serious adverse event rate(0-6 months)