A Phase 2/3 Randomised, Observer-blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Immunogenicity and Safety of the Adjuvanted SARS-CoV-2 Subunit Vaccine in Adults Aged 18 Years and Above
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Primary endpoint - preventing first occurrence of virologically-confirmed (RT-PCR) symptomatic COVID-19 cases as defined by ECDC guidance
研究概览
简要总结
The primary efficacy objective is to demonstrate the efficacy of aCoV2 versus a placebo to prevent the first occurrence of virologically-confirmed symptomatic COVID 19 according to the European Centre for Disease Prevention and Control (ECDC) COVID 19 case definition. The co-primary efficacy objective is to demonstrate the efficacy of aCoV2 versus a placebo to prevent virologically confirmed symptomatic COVID 19 defined by the US Food and Drug Administration (FDA) guidance.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participant and observer-blinded
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)
The experimental group will receive a 2-dose series of 0.5 mL of the study vaccine, administered intramuscularly (IM) into the deltoid muscle, preferably in the non-dominant arm, Day 1 and Day 29 (e.g. 28 days apart)
干预措施: Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2) (Drug)
The Comparator Group - Placebo
The comparator group will receive a 2-dose series of 0.5 mL of the study vaccine, administered intramuscularly (IM) into the deltoid muscle, preferably in the non-dominant arm, Day 1 and Day 29 (e.g. 28 days apart)
干预措施: Comparator (Drug)
结局指标
主要结局
Primary endpoint - preventing first occurrence of virologically-confirmed (RT-PCR) symptomatic COVID-19 cases as defined by ECDC guidance
时间窗: 14 days post vaccination through until 12 months after the last vaccination.
Co-primary endpoint - If successful, the co-primary measure of efficacy is preventing first-occurrence of symptomatic COVID-19 as defined by the US FDA guidance
时间窗: 14 days post vaccination through until 12 months after the last vaccination.
次要结局
- Secondary endpoint #3- number of subjects admitted to ICU with RT-PCR-confirmed COVID-19 versus placebo(14 days post vaccination through until 12 months after the last vaccination)
- Secondary endpoint #2 - number of subjects hospitalized with RT-PCR-confirmed COVID-19 versus placebo(14 days post vaccination through until 12 months after the last vaccination)
- Secondary endpoint #1 - preventing first occurrence of RT-PCR confirmed severe COVID-19(14 days post vaccination through until 12 months after the last vaccination)