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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.
Up to 400 children, ages 2 months through 14 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 90 pediatric, 7 to 14 year old subjects | |||
| 30 pediatric, 5 to 6 year old subjects | |||
| 30 pediatric, 3 to 4 year old subjects | |||
| 30 pediatric, 1 to 2 year old subjects | |||
| 30 pediatric, 6 to 12 month old subjects | |||
| 30 pediatric, 4 to 6 month old subjects | |||
| 30 pediatric, 2 to 4 month old subjects |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 400 children, aged 2 months to 14 years
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Galinkin, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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