NCT00645346已完成1 期
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age
Novartis Vaccines2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2008年2月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine
研究概览
简要总结
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy females 18 through 40 years of age;
- •have provided written informed consent after the nature of the study has been explained;
- •are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
- •are in good health as determined by: medical history ,physical assessment
排除标准
- •unwilling or unable to give written informed consent to participate in the study;
- •pregnant (serum pregnancy test)
- •unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
- •nursing (breastfeeding) mothers
结局指标
主要结局
To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine
时间窗: 1 month
次要结局
- To study the magnitude and durability of GBS-specific antibody responses over 12 months.(12 months)
研究者
研究点 (2)
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