Performance and Safety Evaluation of an Intradermal Delivery Device

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.

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Detailed Description

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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

Interventions

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PATH ID Adapter

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

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 region of both arms.
* 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 region of either arm (scars, rash, infection) or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
* Unable to understand the study purpose or procedures.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes