NCT05003479Unknown1 期
A Randomized, Double-blind, Placebo-controlled Phase Ⅰ Clinical Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years
Shenzhen Kangtai Biological Products Co., LTD1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Incidence of adverse reactions/events
研究概览
简要总结
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy residents aged 3 to 17 years at the time of consent
- •Subjects and/or their guardian agree to sign the informed consent forms voluntarily.
- •Be able to comply with study requirements/procedures.
- •Axillary temperature ≤ 37.0℃
排除标准
- •Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;
- •Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
- •Subjects with history of SARS virus infection by self-reported;
- •Positive in throat swab through RT-PCR;
- •History of vaccination of various COVID-19 vaccines or positive in SARS-CoV-2 antibody test;
- •Positive urine pregnancy test for females with menarche
- •With abnormal indicators, such as blood biochemistry, blood routine, urine routine, thyroid function and coagulation function which might show clinical meaning, before administration;
- •History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;
- •History or family history of convulsion, epilepsy, encephalopathy or mental illness;
- •Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- •Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, drug-uncontrollable hypertension, diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;
- •Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- •History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
- •Subjects receiving anti-TB treatment;
- •Subjects receiving other research drugs within 6 months before vaccination;
- •Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
- •Subjects receiving blood products within 3 months before administration;
- •Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
- •Subjects vaccinated with other vaccine within 7 days before vaccination;
- •The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
结局指标
主要结局
Incidence of adverse reactions/events
时间窗: 0-28 days after each vaccination
次要结局
- Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine, thyroid function and coagulation function)(Day 3 after each dose of vaccination)
- Incidence of Serious Adverse Events (SAE)(within 12 months post full vaccination)
- Geometric mean titer of SARS-CoV-2 IgG binding antibody(28 days, 3 months, 6 months and 12 months post full vaccination)
- Seropositive rate of SARS-CoV-2 neutralizing antibody(3 months, 6 months and 12 months post full vaccination)
- Seropositive rate of SARS-CoV-2 IgG binding antibody(3 months, 6 months and 12 months post full vaccination)
- Seroconversion rate of SARS-CoV-2 neutralizing antibody(28 days post full vaccination)
- Seroconversion rate of SARS-CoV-2 IgG binding antibody(28 days post full vaccination)
- Geometric mean titer of SARS-CoV-2 neutralizing antibody(28 days, 3 months, 6 months and 12 months post full vaccination)
研究者
研究点 (1)
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