NCT07205289招募中1 期
A Phase 1B Open-label Study to Collect Serum Following Vaccination With Killed Whole-cell Pneumococcal Vaccine (Gamma-PN) in Adults for Use in Assay Validation
GPN Vaccines1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年10月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- OPA
研究概览
简要总结
The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation
详细描述
The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation
Participants will receive a dose of Gamma-PN and serum will be collected pre dose and Day 28
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good general health
排除标准
- •no previous pneumococcal vaccine
研究组 & 干预措施
Gamma -PN
Experimental
Intramuscular administration 500 mcg
干预措施: Gamma-PN (Biological)
结局指标
主要结局
OPA
时间窗: 6 months
Opsonophagocytic assay
次要结局
未报告次要终点
研究者
研究点 (1)
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