A Immunobridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated in Population Aged ≥ 60 Years Old and 3-17 Years Old Compared With That in Population Aged 18-59 Years Old
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,400
- 试验地点
- 1
- 主要终点
- The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
研究概览
简要总结
This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules compared to that in population aged 18-59 years old with 2-dose schedule. And subjects in the same age are randomly assigned to different immunization schedule groups.
详细描述
This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules (D0,21,42, D0, 21,111,or D0,21,171)compared to that in population aged 18-59 years old with 2-dose schedule (D0,21). And subjects in the same age are randomly assigned to different immunization schedule groups.
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
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 3 years and above (after enrolled, subjects will be allocated according to age).
- •By asking for medical history and physical examination, the health condition judged by the investigators is well.
- •Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
- •No vaccination history of COVID-19 vaccine before enrollment.
- •Be able and willing to complete the whole prescribed study plan.
- •With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.
排除标准
- •Confirmed cases, suspected cases or asymptomatic infections of SAR-CoV-2 infection (check "China Disease Prevention and Control Information System").
- •Has a history of SARS, MERS infection (self-report, on-site inquiry).
- •>14-year-old subjects axillary temperature ≥37.3℃, ≤14-year-old subjects axillary temperature ≥37.5℃.
- •Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
- •With severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
- •Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
- •Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
- •With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
- •Received immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
- •Received live attenuated vaccinewithin 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
- •Received blood products within 3 months before enrolment.
- •Received other research drugs within 6 months before enrolment.
- •Other circumstances judged by investigators are not suitable for this clinical trial.
研究组 & 干预措施
A1 aged ≥ 71
300 subjects age ≥ 71 （A1）receive 3 doses of vaccine
干预措施: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
A2 aged ≥ 71
200 subjects age ≥ 71 （A2）receive 3 doses of vaccine
干预措施: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
A3 aged ≥ 71
200 subjects age ≥ 71 (A3) receive 3 doses of vaccine
干预措施: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
B1 aged 60-70
300 subjects age 60-70 (B1) receive 3 doses of vaccine
干预措施: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
B2 aged 60-70
200 subjects age 60-70 (B2) receive 3 doses of vaccine
干预措施: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
B3 aged 60-70
200 subjects age 60-70 (B3) receive 3 doses of vaccine
干预措施: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
C1 aged 18-59
300 subjects age 18-59 (C1) receive 3 doses of vaccine
干预措施: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
C2 aged 18-59
200 subjects age 18-59 (C2) receive 3 doses of vaccine
干预措施: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
C3 aged 18-59
200 subjects age 18-59 (C3) receive 3 doses of vaccine
干预措施: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
C4 aged 18-59
300 subjects age 18-59 (C4) receive 2 doses of vaccine
干预措施: 2 doses of vaccine (Biological)
D1 aged 9-17
300 subjects age 9-17 (D1) receive 3 doses of vaccine
干预措施: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
D2 aged 9-17
200 subjects age 9-17 (D2) receive 3 doses of vaccine
干预措施: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
D3 aged 9-17
200 subjects age 9-17 （D3）receive 3 doses of vaccine
干预措施: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
D4 aged 9-17
300 subjects age 9-17 （D4）receive 2 doses of vaccine
干预措施: 2 doses of vaccine (Biological)
E1 aged 3-8
300 subjects age 3-8 （E1） receive 3 doses of vaccine
干预措施: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
E2 aged 3-8
200 subjects age 3-8 （E2）receive 3 doses of vaccine
干预措施: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
E3 aged 3-8
200 subjects age 3-8 （E3）receive 3 doses of vaccine
干预措施: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated (Biological)
E4 aged 3-8
300 subjects age 3-8 （E4）receive 2 doses of vaccine
干预措施: 2 doses of vaccine (Biological)
结局指标
主要结局
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
时间窗: 14 days after the full course immunization
Neutralizing antibody assay will be performed using the Microcytopathic assay
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
时间窗: 14 days after the full course immunization
≥4 fold increase from baseline
次要结局
- The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody(before the third dose in schedules of Day 0,21,111 and Day 0,21,171)
- Safety index-Incidence of serious adverse events(From the beginning of the vaccination to 6 months after the full course immunization)
- The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody(before the third dose in schedules of Day 0,21,111 and Day 0,21,171)
- Immune Persistence(3 months, 6 months, 12 months after the full course immunization)
- Safety index-Incidence of adverse reactions(From the beginning of the vaccination to 28 days after the full course immunization)
- The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody(14 days after the second dose in schedule of Day 0,21,42)
- The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody(14 days after the second dose in schedule of Day 0,21,42)