Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System

Study Overview
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Brief Summary
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The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.

Detailed Description
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Up to 400 children, ages 2 months through 14 years To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings. To document completeness of injections; completeness is defined as <10% of 0.1 ml volume remaining on the skin surface immediately after injection. Measurement of the bleb size following injection will recorded in millimeters. To ensure device is well received by subjects. Subject's response to the injection will be noted by the subject and/or family members after the procedure for up to 48 hours.

Official Title
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Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System

Conditions
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Functionality and Performance of Device

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants and children between ages 2 months and 14 years Outpatient, expected to go home day of surgery Written consent and assent when appropriate Willing to complete and return pain diary (postcard) after 48 hours Exclusion Criteria: Presently have skin rash at the intended injection site Have a history of use of any topical or systemic medications at the intended injection site that could have potentially altered the normal physical properties of the skin (i.e. atrophy from chronic steroid use, thinning of the skin from topical or systemic retinoids). Have a permanent physical change in the skin at the intended injection site, such as burns, scars or prior radiation therapy. Skin disorders that may predispose them to develop skin lesions at sites of trauma. Present use of any blood thinning medications. In the 10-11 year old cohort, none of the participants can have started puberty.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 90 pediatric, 7 to 14 year old subjects<br> | |
| 30 pediatric, 5 to 6 year old subjects<br> | |
| 30 pediatric, 3 to 4 year old subjects<br> | |
| 30 pediatric, 1 to 2 year old subjects<br> | |
| 30 pediatric, 6 to 12 month old subjects<br> | |
| 30 pediatric, 4 to 6 month old subjects<br> | |
| 30 pediatric, 2 to 4 month old subjects<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completeness of injection | To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings. Measurement of the bleb size following injection will recorded in millimeters. | within one minute after injection | 
| Size of bleb on skin after injection | Measurement of the bleb size immediately following injection will be determined using a millimeter ruler | within 2 minutes after injection | 
| Acceptability by subject | subjects response to the injection-level of pain or discomfort. Subjects response will not be collected for those who opt to receive the injections while under anesthesia. | up to 48 hrs |