NCT01977170已完成1 期
Phase 1 Study of Hib Vaccine (Bio Farma)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Incidence rate of adverse event of Hib vaccine (Bio Farma)
研究概览
简要总结
The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.
详细描述
This trial was an open-label study, no randomization, and no placebo or control group. Total 25 young healthy adult (volunteers) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (age 18 - 40 years old)
- •Provision of written informed consent
- •Good health according to the clinical investigator
- •Willingness and ability to adhere to the regimen of the study
排除标准
- •Known not enrolled in other study
- •Pregnancy or lactation
- •Known or suspected allergy to any of the vaccine component (by medical history)
- •History of unusual reaction to any previous vaccination
- •Known or suspected immune deficiency, or use of medication that may influence the immune system
- •Prior respiratory infection
- •Other vaccination during the study, or one week before (inactivated vaccine) or one month (live vaccine) before the study
- •Acute febrile illness (temperature > 37.5 Celsius)
- •Present evidence of serious diseases demanding medical treatment
- •Any significant congenital or chronic disorder
结局指标
主要结局
Incidence rate of adverse event of Hib vaccine (Bio Farma)
时间窗: 30 minutes
Local and systemic reactions
次要结局
- Incidence rate of adverse event of Hib vaccine (Bio Farma)(28 hours, 48 hours, 72 hours, 28 days)
- To evaluate the antibody function serum using serum bactericidal activities test(28 days)
研究者
研究点 (2)
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