Clinical evaluation of hollow microneedle device for painless intradermal vaccination
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- PAIN ASSESSMENT of Hollow Microneddle vacination at the time of inection
研究概览
简要总结
Hollow microneedles are produced by the Instem Research Center, a unit of IISc , Bangalore. Preclinical and benchtesting are conducted in Bangalore at the same institution. We at the Fathere Muller Research Center validate the efficacy and safety of the needle. We use humoid mankins available at our skill lab for validating the efficacy of injectability. Following following injection, volunteers are recruited after obtaining written consent. Anogue visual scales d used to assess the pain score. once the pain score is completed. the vaccination will be done using microdoses. The efficacy of microdose over the full dose is assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Volunteers.
排除标准
- •Recently vaccinated patients with severe illnesses.
结局指标
主要结局
PAIN ASSESSMENT of Hollow Microneddle vacination at the time of inection
时间窗: on intradermal injection, we notice the pain perception by using universal pain at the time of inection once only
次要结局
- Pain score assessment at the time of injection(at the time of injection)
研究者
SANJEEV RAI B
FATHER MULLER RESEARCH CENTRE