NCT01052935已完成1 期
A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotype Ia Antibodies in Women Previously Immunized With a GBS Ia Crm-Glycoconjugate Vaccine
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Antibody (Ab) response data at 24-months after the last injection given in study V98P1 GMCs, GMRs and associated 95% confidence intervals will also be determined
研究概览
简要总结
This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals who have given written consent.
- •Individuals who participated in V98P1 and received the complete schedule of vaccinations.
排除标准
- •Individuals who have not given written consent.
- •Subjects who did not receive the complete schedule of vaccination in V98P1.
研究组 & 干预措施
Arm 1
No Intervention
This is a phlebotomy study.
干预措施: Group B streptococcus (GBS) vaccine (Biological)
结局指标
主要结局
Antibody (Ab) response data at 24-months after the last injection given in study V98P1 GMCs, GMRs and associated 95% confidence intervals will also be determined
时间窗: 24- months post last injection from V98P1
次要结局
未报告次要终点
研究者
研究点 (1)
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