NCT04183322已完成不适用
Reactogenicity and Immunogenicity of Pneumococcal Conjugate Vaccination in Non-pregnant Papua New Guinean Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Immunogenicity
研究概览
简要总结
This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant
- •18-45 years old
排除标准
- •Known hypersensitivity to any vaccine component
- •Known/suspected to be immunocompromised
- •Receipt of corticosteroids ≤30 days before
- •Pregnant (pregnancy tests will be performed)
- •Not being well at the time of vaccination
- •Plan to travel out of the area in the month post-vaccination
结局指标
主要结局
Immunogenicity
时间窗: 28 days
Mean Fold Increase (MFI; and 95% CI) in vaccine-serotype specific IgG concentrations at 28 days after compared to baseline (before vaccination)
次要结局
- Reactogenicity(24-48 hours after vaccination)
- Adverse events(28 days)
研究者
研究点 (1)
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