Multi-center Safety Observation of COVID19 Vaccine in a Large Population
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- SAE
研究概览
简要总结
Popular topic:Multi-center safety observation of recombinant Novel Coronavirus protein vaccine (CHO cells) in a large population Study population:People aged 18 and above
详细描述
Overall design:The aim of this study is to carry out safety studies in the large scale healthy population and special population of recombinant New Coronavirus protein vaccine (CHO cell) in China. It will be included in 100 thousand subjects, including 20 thousand special populations. It is planned to enroll 50000 cases in Hunan (including no less than 10000 special people), 40000 cases in Guizhou (including no less than 8000 special people), and 10000 cases in Hainan (including no less than 2000 special people).
Special groups include but are not limited to obesity, chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc. If the researcher determines that it is necessary, the special population shall provide the medical diagnosis certificate or the drug prescription certificate issued by the doctor.
Immunization program: Subjects who have not received any Novel Coronavirus vaccine or the full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and 2 months, with a dose of 0.5ml for each person.
Immunized subjects: intramuscular injection of one dose of the experimental vaccine into the deltoid muscle of the upper arm, 0.5ml for each person.
Follow up and record:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy people or special people aged 18 and above who meet the requirements of national new coronavirus vaccination (including but not limited to obesity (BMI ≥ 28kg/ m²). Chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc.); If the researcher determines that it is necessary, the special population shall provide relevant written diagnosis certificates, records or drug prescription certificates issued by doctors;
- •The subjects voluntarily participated in the study, signed the informed consent, understood and complied with the requirements of the clinical trial scheme, and were able to understand the research procedures.
排除标准
- •Patients with uncontrolled lymphoproliferative diseases, unresponsive aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled bleeding and coagulation diseases, etc;
- •People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
- •Patients suffering from acute disease, or acute attack of chronic disease, or uncontrolled severe chronic disease;
- •Previous history of severe allergy to any vaccine or any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, Henoch Schonlein purpura, thrombocytopenic purpura, dyspnea, angioneuroedema, etc;
- •The researchers believe that the subject has any disease or condition that may put the subject at unacceptable risk; The subjects could not meet the protocol requirements; Interference with the evaluation of vaccine response.
结局指标
主要结局
SAE
时间窗: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
Serious adverse events (SAE) were collected from the first dose to 1 year after full vaccination and 1 year after booster immunization.
AE
时间窗: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
All AE from the first dose to 30 days after full vaccination and 30 days after booster immunization were collected.
AESI
时间窗: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
Adverse events of special Interest (AESI) analysis 12 months after first dose-full dose and 12 months after booster dose: incidence of adverse events of special interest
次要结局
- ADE/VED(The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose)