NCT00613665已完成1 期
Phase I, Randomized, Controlled, Single-blind, Dose-Ranging and Schedule-Finding Study of the Safety, Tolerability, and Immunogenicity of Chiron Helicobacter Pylori Vaccine in Healthy, Helicobacter Pylori-negative Adults
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2001年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Safety measures: injection site and systemic reactions
研究概览
简要总结
This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine
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
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-40
- •Negative for H. pylori infection
- •Contraception for females
排除标准
- •Present or past H. pylori infection
- •Medically significant gastroduodenal disease
- •Recent corticosteroid use
- •Bleed diathesis
- •Use of antibiotics used to treat H. pylori infection
研究组 & 干预措施
5
Placebo Comparator
干预措施: Placebo (Biological)
6
Experimental
干预措施: helicobacter pylori vaccine (Biological)
4
Experimental
干预措施: helicobacter pylori vaccine (Biological)
3
Experimental
干预措施: helicobacter pylori vaccine (Biological)
2
Experimental
干预措施: helicobacter pylori vaccine (Biological)
1
Experimental
干预措施: helicobacter pylori vaccine (Biological)
7
Experimental
干预措施: helicobacter pylori vaccine (Biological)
结局指标
主要结局
Safety measures: injection site and systemic reactions
时间窗: 5 months
次要结局
- Immunogencity measures: antigen-specific antibodies and cellular immune response(5 months)
研究者
研究点 (1)
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