NCT05572879已完成3 期
A Phase III, Randomized, Observer-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Immunogenicity and Safety of a Preventive COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,600
- 试验地点
- 1
- 主要终点
- The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
研究概览
简要总结
This is a phase III, randomized, observer-blind, active-controlled, parallel group, multi-center study to compare the immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 to ChAdOx1 in healthy adults aged 18 years and older
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
- •Individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent
- •Female of childbearing potential who agree to use medically allowed methods of contraception during the study period
- •Individuals who agrees not to perform blood donation and transfusion during the study period
排除标准
- •Individual being considered to be confirmed COVID-19
- •Direct contact with COVID-19 infected person within 14 days prior to the 1st dose of the IP
- •Individuals at high risk of exposure to SARS-CoV-2
- •Individuals with clinically significant abnormalities in clinical laboratory tests, ECGs, and chest X-ray during screening
- •Individuals with fever within 72 hours prior to the 1st dose of the IP or suspected other infectious disease or symptoms associated with other infectious disease
- •Individuals with serious medical or psychiatric disease
- •History of SARS-CoV or MERS-CoV infection
- •History of allergic reaction or hypersensitivity reactions to any of components of the IP
- •History of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination
- •History of receiving organ or bone marrow transplant
- •Suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination
- •History of vaccination against SARS-CoV, MERS-CoV, or SARS-CoV-2
- •History of vaccination with test vaccine substance
- •Treatment with immunosuppressants or immune modifying drugs
- •History of treatment with antipsychotics or opioid dependence
- •Pregnant or lactating women
- •Other reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
研究组 & 干预措施
Comparator group(ChAdOx1) - Cohort B
Active Comparator
Cohort B - Safety cohort
干预措施: ChAdOx1 nCoV-19 (Biological)
Test group(EuCorVac-19) - Cohort B
Experimental
Cohort B - Safety cohort
干预措施: EuCorVac-19 (Biological)
Comparator group(ChAdOx1) - Cohort A
Active Comparator
Cohort A - Immunogenicity cohort
干预措施: ChAdOx1 nCoV-19 (Biological)
Test group(EuCorVac-19) - Cohort A
Experimental
Cohort A - Immunogenicity cohort
干预措施: EuCorVac-19 (Biological)
结局指标
主要结局
The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
时间窗: 14 days after the 2nd vaccination
The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1
时间窗: 14 days after the 2nd vaccination
次要结局
- Occurrence of solicited Adverse Events (AEs)(Through 7 days after each vaccination)
- Occurrence of unsolicited Adverse Events (AEs)(Through 28 days after the 2nd vaccination)
研究者
研究点 (1)
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