Performance and Safety Evaluation of an Intradermal Delivery Device

Completed · Phase 1

Conditions studied: Injections, Intradermal

In brief

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.

Key facts

Study ID

NCT01359111

Run by

PATH

People needed

20

Starts

2011-05-01

Expected to finish

2011-05-01

Last updated by the study team

2012-05-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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