Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A N=30 Prevention

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

Injections, Intradermal

Bottom Line

View on ClinicalTrials.gov: NCT01943110 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Proportion of Injections Delivered to the Intradermal Layer of the Skin — 28; 30; 30; 30 Injections

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ID adapter (autodisable) (Device); ID adapter (side load) (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
PATH
Primary completion
Jul 2013

Outcome Measures

OutcomeResultp-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 —

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

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.
View full record on ClinicalTrials.gov →

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.

Back to search