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Phase 1 N=20 Prevention

Performance and Safety Evaluation of an Intradermal Delivery Device

Injections, Intradermal

Bottom Line

View on ClinicalTrials.gov: NCT01359111 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Proportion of Injections Delivered to the Intradermal Layer of the Skin — 1 percentage of injections

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
PATH ID Adapter (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
PATH
Primary completion
May 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Injections Delivered to the Intradermal Layer of the Skin		 1 —
SECONDARY
Proportion of Participants With Safety Events		 0.25 —
SECONDARY
Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.		 1; 1 —

Summary

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.

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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01359111). 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.

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