Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44,101
- 试验地点
- 6
- 主要终点
- The incidence of COVID-19 cases after the booster dose of immunization
研究概览
简要总结
This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above. The participants were randomized into three groups of investigational vaccine 1, investigational vaccine 2 and placebo in a 1:1:1 ratio.2 doses of the investigational vaccine or placebo are inoculated into the deltoid muscle of the either arm according to the vaccination schedule of D0 & D21 (+7 days).According to the immune durability results in Phase I/II study, and cross-neutralization assay results, a third dose (booster dose) generates a better immune response and is estimated to offer better protection, therefore, a booster dose will be given after 3 months
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 subjects aged 18 years old and above.
- •By asking for medical history and physical examination, the investigator judged that the health condition 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.
- •During the whole follow-up period of the study, 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 clinical study protocol.
排除标准
- •Confirmed acute cases of SARS-CoV-2 Infection.
- •Have a history of SARS, MERS infection (self-report, on-site inquiry).
- •Positive urine pregnancy test result.
- •Fever (body temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
- •Axillary body temperature > 37.0 ℃ before vaccination.
- •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.
- •Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
- •With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •With severe liver diseases, severe kidney diseases defined as eGFR less than 60, uncontrollable hypertension (systolic blood pressure >150 mmHg, diastolic blood pressure > 90 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.
- •With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, liver and kidney diseases, and malignant tumors.
- •Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
- •Receiving anti-TB therapy.
- •Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
- •Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
- •Received blood products within 3 months before this vaccination
- •Received other research drugs within 6 months before this vaccination.
- •Other circumstances judged by investigators that are not suitable for this clinical trial.
研究组 & 干预措施
Investigational Vaccine 1
Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP according to the immunization schedule of D0 & D21.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) (Biological)
Investigational Vaccine 2
Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP according to the immunization schedule of D0 & D21.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) (Biological)
Placebo
Participants will receive 2 doses of Placebo according to the immunization schedule of D0 & D21.
干预措施: Placebo (Biological)
Investigational Vaccine 1b
Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP after 3 months following two doses of immunization.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) (Biological)
Investigational Vaccine 2b
Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP after 3 months following two doses of immunization.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) (Biological)
Placebo-b
Participants will receive a booster dose of Placebo after 3 months following two doses of immunization.
干预措施: Placebo (Biological)
结局指标
主要结局
The incidence of COVID-19 cases after the booster dose of immunization
时间窗: From 14 days after the booster dose
The incidence of COVID-19 cases after two-doses of vaccination
时间窗: From14 days after the second dose to 6 month after the second dose
次要结局
- The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody(14 days, 28 days and 6th month after the booster dose)
- The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody(14 days, 28 days and 6th month after the booster dose)
- The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination(From 14 day after the booster dose)
- The incidence of any adverse reactions/events(28 days after each immunization)
- The incidence of serious adverse events (SAE)(From the beginning of the first dose to 12 months after the second immunization)
- The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody(14 days, 28 days and 6th month after the booster dose)
- The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody(14 days after full course of immunization)
- The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody(28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization)
- The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody(28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization)
- The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody(28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization)
- The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody(14 days after full course of immunization)
- The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination(From 14 day after the second dose to 6 month after the second dose)
- The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody(14 days after full course of immunization)