NCT00657683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 a 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 65 人开始时间: 2007年12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
- 65
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events.
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, clinical judgment of the investigator
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. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events.
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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