NCT07728396进行中（未招募）1 期
A Phase 1, Randomized, Double-blind, Dose-Escalation, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Preventive Vaccine 'GC4006A' in Healthy Adults Aged 19 to 64 Years
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Solicited local and systemic AEs
研究概览
简要总结
A Phase 1, Randomized, Double-blind, Dose-Escalation, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Preventive Vaccine 'GC4006A' in Healthy Adults Aged 19 to 64 Years
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)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-64 with written informed consent
- •≥16 weeks since last COVID-19 vaccination
排除标准
- •Positive SARS-CoV-2 test (RT-PCR/Rapid Antigen) at screening or randomization
- •<16 weeks since COVID-19 diagnosis
- •History of serious adverse event, allergy, or hypersensitivity to the vaccines
- •Pregnant or lactating women
结局指标
主要结局
Solicited local and systemic AEs
时间窗: From baseline up to 7 days
Acute adverse events
时间窗: From baseline up to 30 minutes
Unsolicited adverse AEs
时间窗: From baseline up to 28 days
次要结局
- Serious adverse events (SAE), Adverse events of special interest (AESI), Medically Attended Adverse Events (MAAE)(From baseline up to week 52)
- Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations(From baseline up to week 52)
- 6. Immunogenicity response (SRR, GMT, GMFR for neutralizing antibodies; SRR, GMC, GMFR for binding antibodies)(From baseline up to week 52)
研究者
研究点 (1)
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