NCT02099149撤回不适用
Establishing a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less Than 90 Days.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Novartis
- 试验地点
- 1
- 主要终点
- Early onset Group B Streptococcus Disease due to serotypes Ia or III
研究概览
简要总结
Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.
- •Subjects aged ≥18 years.
- •Able to understand and comply with planned study procedures.
- •Provides written informed consent.
排除标准
- •Refuses to consent to study participation.
结局指标
主要结局
Early onset Group B Streptococcus Disease due to serotypes Ia or III
时间窗: 0-6 days
Risk of early onset Group B Streptococcus disease (due to serotypes Ia or III) with respect to maternal or newborn anticapsular antibody levels at delivery
次要结局
- Late onset Group B Streptococcus Disease due to serotype III(7-90 days)
研究者
研究点 (1)
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