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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-07-31

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

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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.

Conditions

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Injections, Intradermal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Saline injection with ID adapters

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

Group Type EXPERIMENTAL

ID adapter (autodisable)

Intervention Type DEVICE

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.

ID adapter (side load)

Intervention Type DEVICE

Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.

Interventions

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ID adapter (autodisable)

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.

Intervention Type DEVICE

ID adapter (side load)

Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.

Intervention Type DEVICE

Other Intervention Names

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Autodisable intradermal adapter AD ID adapter

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes