A Bridging Study to Evaluate Safety of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 5 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general).
研究概览
简要总结
An open label, non-comparative bridging study to evaluate the safety of Rabies vaccine INDIRAB® in Healthy Vietnamese volunteer aged from 5 years old.
详细描述
The trial is a bridging study to evaluate safety of Rabies vaccine INDIRAB® Five Doses (0.5 ml) post exposure administered Intramuscularly in healthy Vietnamese Volunteer Aged from 5 years old. 120 subjects will be enrolled in Cho Gao district, Tien Giang province, in which there are 100 adults (≥15 years old) and 20 children (5-<15 years old). These subjects will be received 5 doses (0.5ml) INDIRAB® on D0, 3, 7, 14 and 28.
The frequency, rate and severity of immediate adverse events (AE) within 30 minutes after vaccination, solicited and unsolicited AE within 7 days after each vaccination, the frequency and rate of serious adverse events (SAE) within 35 days after the first vaccination will be recorded as evidences for INDIRAB® safety assessment. The subjects to be included from this trial would be representative of the population of Vietnam.
The protocol has been reviewed and approved by Institutional Review Board of Pasteur Institute in Ho Chi Minh City and Vietnam Ministry of Health - Independent Ethics Committee and Vietnam Minister of Health.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female aged from 5 years old. Women of childbearing age must use an appropriate method of contraception.
- •Subjects had sign written consent form to participate in the study. With subjects aged from 5 to below 18 years old, parents/legal representative had sign written consent form for children to participate in this study.
- •Subject who gave voluntary to comply with the study requirements.
排除标准
- •Subjects have atopic allergy or severe allergy to any component of vaccine.
- •Subjects with mental illness, mental retardation.
- •Subjects with severe acute or chronic disease may affect safety (eg: hepatobiliary disease, kidney disease, diabetes, hypertension...).
- •Subjects received rabies vaccine.
- •Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
- •Subjects who received other vaccine within 28 days before INDIRAB® vaccination, or those who had another vaccination schedule during the study.
- •Pregnant or lactating women.
- •Subjects had been participated, are participating, are going to participate in any other clinical trials during the period of this study.
结局指标
主要结局
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general).
时间窗: 30 minutes after vaccination
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of solicited and unsolicited adverse events.
时间窗: For 7 days after each vaccination
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of Serious Adverse Events.
时间窗: Within 35 days after the first vaccination
次要结局
未报告次要终点
研究者
Le Hoang San
Principal Investigator
Pasteur Institute, Ho Chi Minh City