Ignite Creation Date:
2024-05-05 @ 9:53 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00987350
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2009-09-29
Brief Title:
Safety Study of Seasonal Influenza Vaccine by Jet Injection
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Clinical Study to Assess the Safety Tolerability and Immunogenicity of Licensed Seasonal Trivalent Influenza Vaccine Administered by Needle-free Jet Injection in One Intramuscular Dose to Healthy Young Adults
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study involves testing of a device that can give injections shots without the use of a needle
Detailed Description:
The device is called LectraJet M3 and has recently been approved by the Food and Drug Administration or FDA the government agency that oversees the approval of new medical devices The approval is called a 510k and allows for the marketing and use of the device in the United States US Devices under a 510k do not need to have clinical trials performed The researchers are performing this study in order to collect clinical data in a controlled environment Non significant risk NSR devices such as the LectraJet may be studied in clinical trials with or without a 510k Currently there are several other disposable-syringe jet injectors that are also FDA approved for sale and use in the United States including 1 Biojector 2000 2 Medi-Jector Vision and 3 Injex These devices have been used to deliver millions of injections in a variety of healthcare settings The LectraJet is jet injector that is most suited for mass immunization campaigns due to the ability to power the device with a foot pedal as well as electricity and the speed with which immunizations can be delivered It is designed so that vaccine delivery characteristics are the same as that of the licensed disposable-syringe jet injectors
Giving vaccines without needles needle-free vaccine delivery may be better than giving them using a needle for many reasons One method for giving shots without needles is a technique called jet injection This is what the researchers are testing in this study A jet injector pushes the vaccine fluid out of a small hole at a high enough speed to allow the vaccine to go under the subjects skin without needing a needle Years ago people got shots using jet injectors but these older devices reused the same nozzle or hole through which the fluid was forced Newer jet injectors including the one the researchers are testing in this study use disposable cartridges to hold the vaccine So the only thing that touches the subjects skin is their own cartridge which gets thrown away after injection
In this study the volunteers are getting the licensed seasonal flu vaccine to see if the jet injector works as well as giving the vaccine by needle and syringe The seasonal flu vaccine that the researchers are using is called trivalent influenza vaccine TIV It is licensed in the US to protect people 6 months of age and older against influenza Influenza is a virus that is also commonly known as the flu The flu is a serious illness that kills over 35000 people per year in the US alone The flu virus constantly changes and that is why people who are at risk for developing complications from the flu such as children the elderly and people with underlying health conditions need to be vaccinated every year Volunteers will receive the 2009-2010 annual seasonal flu vaccine called TIV either by needle and syringe or by jet injection The researchers will compare the side effects and see how well the vaccine generates an immune response when given by the two methods
Giving vaccines without needles needle-free vaccine delivery may be better than giving them using a needle for many reasons One method for giving shots without needles is a technique called jet injection This is what the researchers are testing in this study A jet injector pushes the vaccine fluid out of a small hole at a high enough speed to allow the vaccine to go under the subjects skin without needing a needle Years ago people got shots using jet injectors but these older devices reused the same nozzle or hole through which the fluid was forced Newer jet injectors including the one the researchers are testing in this study use disposable cartridges to hold the vaccine So the only thing that touches the subjects skin is their own cartridge which gets thrown away after injection
In this study the volunteers are getting the licensed seasonal flu vaccine to see if the jet injector works as well as giving the vaccine by needle and syringe The seasonal flu vaccine that the researchers are using is called trivalent influenza vaccine TIV It is licensed in the US to protect people 6 months of age and older against influenza Influenza is a virus that is also commonly known as the flu The flu is a serious illness that kills over 35000 people per year in the US alone The flu virus constantly changes and that is why people who are at risk for developing complications from the flu such as children the elderly and people with underlying health conditions need to be vaccinated every year Volunteers will receive the 2009-2010 annual seasonal flu vaccine called TIV either by needle and syringe or by jet injection The researchers will compare the side effects and see how well the vaccine generates an immune response when given by the two methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LectraJet-TIV CVD 1000 | None | None | None |