jRCT2031230503进行中（未招募）不适用
A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Investigate the Immunogenicity of a Booster Dose of S-268023 compared with COMIRNATY (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants aged 20 years or older, at the time of sigining the informed consent form.
- •Participants who have passed 90 days or more after completing the primary vaccination or booster vaccination with an approved SARS-CoV-2 vaccine (excluding an approved monovalent XBB.1.5 SARS-CoV-2 vaccine).
- •Participants with no infection history of SARS-CoV-2, or participants with infection history of SARS-CoV-2 who have not been infected since March
- •Male and female.
排除标准
- •Participants who have previously received an approved monovalent XBB.1.5 SARS-CoV-2 vaccines.
- •Participants who tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening.
结局指标
主要结局
-
SARS-CoV-2 neutralizing antibody titer on day 29 (XBB.1.5 variant) -GMT -Seroresponse rate
次要结局
未报告次要终点
研究者
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