NCT04830358已完成1 期
A Single Center, Randomized, Single-blind, Active Comparator Phase 1 Clinical Trial to Assess the Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Unsolicited AEs
研究概览
简要总结
The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19 to 50 years old
- •Participants willing to give written informed consent to participate in the trial
排除标准
- •History of invasive pneumococcal infection within 5 years at screening
- •Known hypersensitivity to any component of the study vaccine
- •Immune deficiency or immunosuppressive disorder
- •Immunized with any licensed vaccine within 4 weeks prior to screening
- •Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
- •Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure
结局指标
主要结局
Incidence of Unsolicited AEs
时间窗: within 28 days after vaccination
Incidence of Solicited AEs (Local and Systemic)
时间窗: within 14 days after vaccination
Incidence of SAEs
时间窗: within 180 days after vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
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