A Phase 3, Randomized, Observer-Blind, Placebo- Controlled Cross-over Study to Evaluate the Efficacy, Safety, and Immunogenicity of S-268019 for the Prevention of COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9,902
- 试验地点
- 1
- 主要终点
- Number of Participants With First Occurrence of SARS-CoV-2 Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Positive Symptomatic COVID-19 With Onset at Least 14 Days Following Second Vaccination During the Initial Vaccination Period
研究概览
简要总结
The main purpose of this study is to assess the efficacy of S-268019-b for the prevention of COVID-19 in the initial vaccination period prior to crossover in participants without evidence of infection before vaccination as compared to placebo.
详细描述
Eligible participants will be randomized to receive either S-268019-b or placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods, an initial vaccination period (Day 1 to Day 224), and a crossover vaccination period (Day 225 to Day 435).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Agree not to participate in any other SARS-CoV-2 prevention trial during the study follow-up.
- •Capable of using Diary without difficulties (if applicable, with assistance by caregiver).
排除标准
- •Current or history of a laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-
- •Unstable current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation.
- •Immunosuppression (immunodeficiency, acquired immunodeficiency syndrome [AIDS], use of systemic steroids, use of immunosuppressants within the past 6 months prior to the first dose of study intervention, treatment for malignant tumors, other immunosuppressive therapy).
- •Previous vaccination against SARS-CoV-
- •Any inactivated vaccine received within 14 days prior to the first dose of study intervention.
- •Any live vaccine received within 28 days prior to the first dose of study intervention.
- •Immunoglobulin preparations, blood products, or a blood transfusion within 3 months prior to the first dose of study intervention.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
S-268019-b, Then Placebo
Participants will first receive a dose of S-268019-b via intramuscular (IM) injection on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive a placebo IM injection (matching S-268019-b) on Day 225 and Day 253.
干预措施: S-268019-b (Drug)
S-268019-b, Then Placebo
Participants will first receive a dose of S-268019-b via intramuscular (IM) injection on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive a placebo IM injection (matching S-268019-b) on Day 225 and Day 253.
干预措施: Placebo (Drug)
Placebo, Then S-268019-b
Participants will first receive a dose of placebo IM injection (matching S-268019-b) on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive S-268019-b IM injection on Day 225 and Day 253.
干预措施: S-268019-b (Drug)
Placebo, Then S-268019-b
Participants will first receive a dose of placebo IM injection (matching S-268019-b) on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive S-268019-b IM injection on Day 225 and Day 253.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With First Occurrence of SARS-CoV-2 Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Positive Symptomatic COVID-19 With Onset at Least 14 Days Following Second Vaccination During the Initial Vaccination Period
时间窗: From Day 43 (14 days after the second dose administration) to Day 224
Participants without evidence of infection before vaccination (that is, seronegative and PCR-negative at baseline) were determined to have symptomatic COVID-19 when at least 1 protocol-specified COVID-19-related symptom and a positive RT-PCR test result were confirmed by the medical monitor within at least 14 days following the second vaccination. RT-PCR testing was based upon nasopharyngeal swab sampling at protocol-specified timepoints.
次要结局
- Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody(Day 57)
- Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period(Up to Day 224)
- Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period With Onset at Least 14 Days Following Second Vaccination(From Day 43 (14 days after the second dose administration) to Day 224)
- Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period(Up to Day 224)
- Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period Regardless of Serostatus or PCR Status at Baseline With Onset at Least 14 Days Following Second Vaccination(From Day 43 (14 days after the second dose administration) to Day 224)
- Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period With Onset at Least 14 Days Following Second Vaccination Regardless of Serostatus or PCR Status at Baseline(From Day 43 (14 days after the second dose administration) to Day 224)
- Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period Regardless of Serostatus or PCR Status at Baseline(Up to Day 224)
- Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period Regardless of Serostatus or PCR Status at Baseline(Up to Day 224)
- Number of Participants With First Occurrence of Asymptomatic SARS-CoV-2 Infection in the Initial Vaccination Period(From Day 43 (14 days after the second dose administration) to Day 224)
- Percentage of Participants Experiencing Solicited Systemic Adverse Events(Up to Day 224)
- Percentage of Participants Experiencing Solicited Local Adverse Events(Up to Day 224)
- Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody(Day 57)
- Seroconversion Rate of SARS-CoV-2 Neutralizing Antibody(Day 57)
- GMT of Anti-SARS-CoV-2 S-protein Immunoglobulin G (IgG) Antibody(Day 57)
- GMFR of Anti-SARS-CoV-2 S-protein IgG Antibody(Day 57)
- Seroconversion Rate of Anti-SARS-CoV-2 S-protein IgG Antibody(Day 57)