NCT04508075已完成3 期
A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 1,620
- 试验地点
- 1
- 主要终点
- Incidence of laboratory-confirmed COVID-19 after the second dose
研究概览
简要总结
This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
详细描述
This trial is Randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study
Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine.
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)
盲法说明
Observer blind Investigational Product and Active Comparator was masking Number of lot was masking
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy adults aged 18 - 59 years.
- •Subjects have been informed properly regarding the study and signed the informed consent form.
- •Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
排除标准
- •Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- •Contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial.
- •Contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial.
- •Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial.
- •Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- •The result of RT-PCR of swab nasopharyngeal is positive
- •Reactive IgG and IgM for SARS-CoV-2 (by standardize rapid test).
- •Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- •History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
- •Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
- •Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome
- •Subjects receive any vaccination within 1 month before and after IP immunization.
- •Subjects plan to move from the study area before the end of study period.
结局指标
主要结局
Incidence of laboratory-confirmed COVID-19 after the second dose
时间窗: 14 days to 6 months after the second dose
Percentage of laboratory-confirmed COVID-19 cases
次要结局
- Incidence of suspected COVID-19 cases(within 14 days to 6 months after the second dose.)
- Seropositive rate of neutralizing antibodies(6 months after two doses of vaccination)
- Incidence of laboratory-confirmed cases (severe, critical and death)(within 14 days to 6 months after the second dose)
- Seroconversion rate anti-S antibody IgG titer (ELISA)(6 months after two doses of vaccination)
研究者
研究点 (1)
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