N/A
Completed N=30
Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.
Injections, Intradermal
Source: ClinicalTrials.gov NCT01943110 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Proportion of Injections Delivered to the Intradermal Layer of the Skin — 28; 30; 30; 30 Injections
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Injections Delivered to the Intradermal Layer of the Skin |
28; 30; 30; 30; 30; 30 | — |
| SECONDARY Proportion of Injections With Safety Events |
5.6; 4.4; 0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01943110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.