Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.

Study Overview
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Brief Summary
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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

Detailed Description
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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. Injections will be assessed for safety by observation of injection sites for any local adverse events.

Official Title
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A Clinical Trial to Evaluate the Performance and Safety of Two Intradermal Delivery Devices.

Conditions
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Injections, Intradermal

Intervention / Treatment
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* Device: ID adapter (autodisable)
* Device: ID adapter (side load)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: - 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saline injection with ID adapters<br>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 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 | Device: ID adapter (autodisable)<br>* Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.<br>* Other names: AD ID adapter;Device: ID adapter (side load)<br>* Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Injections Delivered to the Intradermal Layer of the Skin | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Injections With Safety Events | The proportion of injections with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection. | Within 30 minutes and within 48 hours of injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intradermal injections, Vaccine delivery devices