Ensayo Clínico de Fase III, Aleatorio, Doble Ciego y Controlado Con Placebo Paralelo, Para Evaluar la Seguridad y la Eficacia Protectora de la Vacuna Inactivada Contra el SARS-CoV-2 en la Población Sana de 18 años o más, en Perú
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12,000
- 试验地点
- 2
- 主要终点
- Proportion of confirmed Covid-19 cases in the two vaccine groups and the placebo group.
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
Product characteristics:
WIBP:
The inactivated SARS CoV 2 Vaccine (Vero cell) is prepared by inoculating Verda Reno cells (Vero cell) with SARS CoV 2 WIV04 strain, culturing, harvesting, inactivating, clarifying, concentrating, second inactivating, purifying and adding aluminum hydroxide adjuvant BIBP: The inactivated SARS CoV 2 Vaccine (Vero cell) is prepared by inoculating Verda Reno cells (Vero cell) with SARS CoV 2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying and adding aluminum hydroxide adjuvant. After vaccination, the body can produce immune response to prevent diseases caused by SARS CoV 2.
Primary objective To evaluate the protective efficacy of inactivated SARS CoV 2 Vaccine (Vero Cell) after full course of immunization in preventing diseases caused by the SARS CoV 2 in healthy subjects aged 18 years old and above.
Study design:
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)
盲法说明
Researchers and participants are masked to Intervention group. Individual syringes are coded with a consecutive number only
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
- •Age range: 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 do not plan to become pregnant within the first 3 months after enrolment . Effective contraceptive measures have been taken within 2 weeks before inclusion and continued for at least three month s after last dose
- •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 research procedures, with 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
- •SARS CoV 2 Infection Confirmed Cases, Suspected Cases or Asymptomatic Infection
- •SARS CoV 2 Nucleic acid test positive
- •Have a history of SARS , MERS infection (self report, on site inquiry
- •Fever (axillary 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.
- •Have a history of convulsion, epilepsy, encephalopathy or mental illness or family history
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •Severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure ≥ 140 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
- •Diseases known or suspected include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors. - Hist ory 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
- •Live attenuated va ccine 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 vacc ination
- •Investigator judged other circumstances that are not suitable for this clinical trial.
结局指标
主要结局
Proportion of confirmed Covid-19 cases in the two vaccine groups and the placebo group.
时间窗: One year beginning on day 14 after the second dose of immunization
Protective effect against COVID 19, after 14 days following the full course of vaccination among healthy population aged 18 years old and above. Comparison of the proportions of confirmed Covid-19 cases in the two vaccine groups and the placebo group. All confirmed cases are all confirmed by DSMB blind examination.
次要结局
- Incidence of any adverse reactions/events(12 months)
- Proportion of severe cases of SARS CoV 2 pneumonia and deaths in the two vaccine groups and the placebo group.(One year beginning on day 14 after the second dose of immunization)