A Clinical Trial to Evaluate the Performance and Safety of Two Intradermal Delivery Devices.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Proportion of Injections Delivered to the Intradermal Layer of the Skin
研究概览
简要总结
The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations
详细描述
This study is a preliminary device safety and performance evaluation in healthy adult volunteers (ages 18-55 years).
Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
- Upper deltoid with the side-load ID adapter
- Upper deltoid with the autodisable (AD) ID adapter
- Suprascapular (behind the shoulder) with the side-load ID adapter
- Suprascapular with the AD ID adapter
- Forearm with the side-load ID adapter
- Forearm with the AD ID adapter
Intradermal administration of each injection will be assessed:
- The liquid remaining on the surface of the skin will be blotted with absorbent paper and the amount of liquid present will be recorded.
- The formation of an intradermal wheal will be observed, and the diameter of the wheal measured using a ruler or similar measurement tool.
- A photo of the injection site will be taken.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male participants ages 18 to 55 years.
- •Healthy enough to participate in the clinical trial per site investigator assessment.
- •Healthy skin on the upper deltoid, suprascapular, and forearm regions (both sides of the body).
- •Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
- •Literate in English.
- •Available by telephone 48 hours after the study visit.
排除标准
- •Skin abnormalities on upper deltoid, suprascapular, and forearm regions of either side of the body (scars, rash, infection), tattoo at the injection site, or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
结局指标
主要结局
Proportion of Injections Delivered to the Intradermal Layer of the Skin
时间窗: 1 day
The proportion of saline injections resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.
次要结局
- Proportion of Injections With Safety Events(Within 30 minutes and within 48 hours of injection)