Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Monovalent Omicron XBB.1.5 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine
研究概览
简要总结
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
详细描述
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
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
- •Male or female ≥18 years of age.
- •Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
- •Individuals willing and able to give an informed consent, prior to screening.
- •Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
- •Individuals who received three doses of inactivated COVID-19 vaccine
排除标准
- •Body temperature >37.8°C (axillary), or any acute illness at baseline.
- •Confirmed SARS-CoV-2 infectionor with known history of COVID-
- •Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
- •Any progressive unstable or uncontrolled clinical conditions.
- •Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
- •History of severe adverse reaction associated with a vaccine or severe allergic reaction.
- •History of malignancy within 1 year before screening.
- •Individuals who have received any other investigational product.
- •Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
- •Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
- •Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
- •Administration of intravenous immunoglobulins and/or any blood products.
- •Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
结局指标
主要结局
Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine
时间窗: Day 7
Proportion of participants with local and systemic AEs
GMT ratio
时间窗: Day 15
Demonstrate that SCB-2023B vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
时间窗: Up to 1 year post-vaccination
Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs
次要结局
- SCRs(Day 1, 15)
- Proportion of subjects with antibody titer >=LLOQ(Day 1, 15)
- GMFRs(Day 1, 15)
- Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5(Day 1, 15, 180)
- Non-inferiority of the Omicron XBB.1.5 immune response elicited by SCB-2023B vaccine versus SARS-CoV-2 Delta titers in a subset of naïve participants of the CLO-SCB-2019-003 clinical study (virus neutralization assay)(Day 15)
- GMTs(Day 1, 15)