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
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
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)
Loading locations...
相似试验
Unknown
3 期
A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)Acute Otitis ExternaNCT04636957Lee's Pharmaceutical Limited600
已完成
3 期
A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and OlderCOVID-19NCT05603052EuBiologics Co.,Ltd2,852
已完成
3 期
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic ChemotherapyChemotherapy-induced Nausea and VomitingNCT01500213Tesaro, Inc.555
已完成
3 期
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic ChemotherapyChemotherapy-induced Nausea and VomitingNCT01500226Tesaro, Inc.1,369
已完成
3 期
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic ChemotherapyChemotherapy-induced Nausea and VomitingNCT01499849Tesaro, Inc.532