Healthy AdultsPhase 4NCT00987350
Safety Study of Seasonal Influenza Vaccine by Jet Injection
A Phase 4 study testing LectraJet, TIV by jet injection and Seasonal Trivalent Influenza Vaccine in people with Healthy Adults, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This research study involves testing of a device that can give injections (shots) without the use of a needle. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- LectraJet, TIV by jet injection and Seasonal Trivalent Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 and 49 years, inclusive
- In good health as evidenced by screening evaluation within the 30 days prior to immunization.
- Expressed interest and availability to fulfill the study requirements.
- Signed, informed consent.
- For women of child-bearing potential, agreement to avoid pregnancy for the 90 days following vaccination by use of effective birth control methods.
- Agreement to refrain from taking any experimental drug or vaccine from Day minus 30 to Day 90 (from screening until the volunteer completes the study).
Who cannot join
- A known allergy to a component of the vaccine, including egg, egg products, chicken proteins, formaldehyde, gentamicin sulfate, or sodium deoxycholate.
- A positive urine pregnancy test in the 24 hours prior to vaccination. (A negative urine pregnancy test is required within the 24 before vaccination for all women who have not had a hysterectomy or are not at least 1 year post-menopausal)
- A woman who is breastfeeding.
- Any current medical illness that might jeopardize the volunteer's safety or interfere with the interpretation of the study results. These include, but are not limited to the following: cancer; immunodeficiency; bleeding disorder.
- Any underlying medical condition for which influenza vaccination is recommended: chronic heart or lung conditions, including asthma; metabolic diseases; kidney disease; blood disorder (such as sickle cell anemia); weakened immune systems, including HIV/AIDS.
- Resident of nursing homes and long term care facility.
Show all 20Show fewer
- Health care worker involved in direct patient care.
- Any current illness requiring daily medication, except for vitamins, contraceptives, topical medications, antihistamines, antacids and other reflux medications, smoking cessation medications, headache medications that do not have antipyretic activity, nasal allergy medications, ophthalmologic and otic medications, psychiatric medications for well-controlled conditions such as depression or anxiety, and thyroxine for stable, inactive hypothyroidism. Volunteers may not take daily oral, nasal, inhaled, or parenteral steroids or non-steroidal anti-inflammatory medications. Medications other than those mentioned above will require approval from the PI, the sponsor, and the medical monitor.
- Any use of antibiotics in the 7 days before enrollment.
- Vital signs that are abnormal and thought by the investigator to increase the risk to the volunteer. Mild elevations or depressions of blood pressure or heart rate may be allowed.
- Current alcohol or illicit drug dependence.
- History of receipt of an influenza vaccine in the 2008-2009 and/or 2009-2010 season
- History of Guillain-Barré Syndrome
- Failure to pass the written exam; a passing score is 70% or greater.
- Receipt of an experimental agent (e.g., a vaccine or medication) within the 30 days prior to enrollment or the expectation of receipt of an experimental agent while participating in this study.
- Receipt of a live, attenuated vaccine within the 30 days prior to enrollment.
- Receipt of a subunit or killed vaccine within the 14 days prior to enrollment.
- Receipt of a blood product, including immunoglobulin, in the 90 days prior to enrollment.
- Oral temperature > 37.7 degrees C or other acute illness occurring prior to inoculation on the day of vaccination. (This will lead to postponement of enrollment, not exclusion from the trial. Mild resolving illnesses may be allowed at the discretion of the investigator)
- Anything that, in the opinion of the investigator, will compromise the participation of the volunteer with respect to his/her rights or risks.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland College Park Health Center
College Park, Maryland
About this study
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
This research study involves testing of a device that can give injections (shots) without the use of a needle.
Read the 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 510(k) and allows for the marketing and use of the device in the United States (US). Devices under a 510(k) 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 510(k). 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 subject's 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 subject's 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 35,000 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.
- Conditions
- Healthy Adults
- Being tested
- LectraJet, TIV by jet injection, Seasonal Trivalent Influenza Vaccine
- Keywords
- Jet Injector, Vaccine, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LectraJetDevice
LectraJet is a new jet injector studied for the first time in humans. It is in the category known as disposable-syringe jet injectors that have the advantage of eliminating the risk of disease transmission between subjects. A new syringe and nozzle is used for each patient so that no splash back of blood can occur onto the jet apparatus itself.
TIV by jet injectionDevice
Administration of seasonal trivalent influenza vaccine (TIV) by jet injection
Seasonal Trivalent Influenza VaccineBiological
Licensed trivalent influenza vaccine provided by either jet injection or traditional needle and syringe.
| Study group | Role | What they receive |
|---|---|---|
| Trivalent influenza vaccine by needle and syringe | Active comparator | Thirty volunteers will receive 1 intramuscular (IM) dose of licensed trivalent inactivated 2009-10 seasonal influenza vaccine by the standard needle and syringe method Receives: Device: TIV by jet injection; Biological: Seasonal Trivalent Influenza Vaccine |
| Trivalent influenza vaccine by jet injection | Experimental | Thirty volunteers will receive 1 intramuscular (IM) dose of licensed trivalent inactivated 2009-10 seasonal influenza vaccine by the experimental method of jet injection Receives: Device: LectraJet; Biological: Seasonal Trivalent Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE) and serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessment)
Measured: 90 Days
Secondary outcomes (3)
Proportion of volunteers in each administration group achieving a greater than four-fold rise in hemagglutination inhibition (HI) titer from pre-vaccination to 28 days post-vaccination against each of the vaccine-associated strains
Measured: Day 28
Proportion of volunteers in each administration group achieving a HI titer >40 on day 28 post-vaccination against each of the vaccine-associated strains
Measured: Day 28
Geometric mean titer (GMT) of HI titers against each of the vaccine-associated strains in each group 28 days after receipt of the vaccine
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- D'Antonio Consultants International, Inc.
- Responsible party
- Principal investigator, Karen Kotloff, University of Maryland, Baltimore
- Investigators
- Jakub K Simon, MD, MS, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987350
- Sponsor's protocol ID
- HP-00042669
- Other IDs
- LectraJet-TIV CVD 1000
- Status last verified
- Apr 2021
- First submitted
- 29 Sep 2009
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Parent du Chatelet I, Lang J, Schlumberger M, Vidor E, Soula G, Genet A, Standaert SM, Saliou P. Clinical immunogenicity and tolerance studies of liquid vaccines delivered by jet-injector and a new single-use cartridge (Imule): comparison with standard syringe injection. Imule Investigators Group. Vaccine. 1997 Mar;15(4):449-58. doi: 10.1016/s0264-410x(96)00173-9.
PubMed 9141217Fisch A, Cadilhac P, Vidor E, Prazuck T, Dublanchet A, Lafaix C. Immunogenicity and safety of a new inactivated hepatitis A vaccine: a clinical trial with comparison of administration route. Vaccine. 1996 Aug;14(12):1132-6. doi: 10.1016/0264-410x(96)00044-8.
PubMed 8911009Williams J, Fox-Leyva L, Christensen C, Fisher D, Schlicting E, Snowball M, Negus S, Mayers J, Koller R, Stout R. Hepatitis A vaccine administration: comparison between jet-injector and needle injection. Vaccine. 2000 Mar 17;18(18):1939-43. doi: 10.1016/s0264-410x(99)00446-6.
PubMed 10699344
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00987350
- Acronym / sponsor ID
- HP-00042669
- Conditions
- Healthy Adults
- Keywords
- Jet Injector, Vaccine, Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- D'Antonio Consultants International, Inc.
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 510(k) and allows for the marketing and use of the device in the United States (US). Devices under a 510(k) 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 510(k). 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 subject's 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 subject's 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 35,000 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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trivalent influenza vaccine by needle and syringe | Active comparator | Device: TIV by jet injection, Biological: Seasonal Trivalent Influenza VaccineThirty volunteers will receive 1 intramuscular (IM) dose of licensed trivalent inactivated 2009-10 seasonal influenza vaccine by the standard needle and syringe method |
| Trivalent influenza vaccine by jet injection | Experimental | Device: LectraJet, Biological: Seasonal Trivalent Influenza VaccineThirty volunteers will receive 1 intramuscular (IM) dose of licensed trivalent inactivated 2009-10 seasonal influenza vaccine by the experimental method of jet injection |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 and 49 years, inclusive
- In good health as evidenced by screening evaluation within the 30 days prior to immunization.
- Expressed interest and availability to fulfill the study requirements.
- Signed, informed consent.
- For women of child-bearing potential, agreement to avoid pregnancy for the 90 days following vaccination by use of effective birth control methods.
Key exclusion criteria (20 listed)
- A known allergy to a component of the vaccine, including egg, egg products, chicken proteins, formaldehyde, gentamicin sulfate, or sodium deoxycholate.
- A positive urine pregnancy test in the 24 hours prior to vaccination. (A negative urine pregnancy test is required within the 24 before vaccination for all women who have not had a hysterectomy or are not at least 1 year post-menopausal)
- A woman who is breastfeeding.
- Any current medical illness that might jeopardize the volunteer's safety or interfere with the interpretation of the study results. These include, but are not limited to the following: cancer; immunodeficiency; bleeding disorder.
- Any underlying medical condition for which influenza vaccination is recommended: chronic heart or lung conditions, including asthma; metabolic diseases; kidney disease; blood disorder (such as sickle cell anemia); weakened immune systems, including HIV/AIDS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LectraJetLectraJet is a new jet injector studied for the first time in humans. It is in the category known as disposable-syringe jet injectors that have the advantage of eliminating the risk of disease transmission between subjects. A new syringe and nozzle is used for each patient so that no splash back of blood can occur onto the jet apparatus itself. | Device | Trivalent influenza vaccine by jet injection |
| TIV by jet injectionAdministration of seasonal trivalent influenza vaccine (TIV) by jet injection | Device | Trivalent influenza vaccine by needle and syringe |
| Seasonal Trivalent Influenza VaccineLicensed trivalent influenza vaccine provided by either jet injection or traditional needle and syringe. | Biological | Trivalent influenza vaccine by jet injection, Trivalent influenza vaccine by needle and syringe |
Primary outcome
Adverse event (AE) and serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessment)
Time frame: 90 Days
3 secondary outcomes
Proportion of volunteers in each administration group achieving a greater than four-fold rise in hemagglutination inhibition (HI) titer from pre-vaccination to 28 days post-vaccination against each of the vaccine-associated strains
Time frame: Day 28
Proportion of volunteers in each administration group achieving a HI titer >40 on day 28 post-vaccination against each of the vaccine-associated strains
Time frame: Day 28
Geometric mean titer (GMT) of HI titers against each of the vaccine-associated strains in each group 28 days after receipt of the vaccine
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Background: PubMed 9141217Parent du Chatelet I, Lang J, Schlumberger M, Vidor E, Soula G, Genet A, Standaert SM, Saliou P. Clinical immunogenicity and tolerance studies of liquid vaccines delivered by jet-injector and a new single-use cartridge (Imule): comparison with standard syringe injection. Imule Investigators Group. Vaccine. 1997 Mar;15(4):449-58. doi: 10.1016/s0264-410x(96)00173-9.
- Background: PubMed 8911009Fisch A, Cadilhac P, Vidor E, Prazuck T, Dublanchet A, Lafaix C. Immunogenicity and safety of a new inactivated hepatitis A vaccine: a clinical trial with comparison of administration route. Vaccine. 1996 Aug;14(12):1132-6. doi: 10.1016/0264-410x(96)00044-8.
- Background: PubMed 10699344Williams J, Fox-Leyva L, Christensen C, Fisher D, Schlicting E, Snowball M, Negus S, Mayers J, Koller R, Stout R. Hepatitis A vaccine administration: comparison between jet-injector and needle injection. Vaccine. 2000 Mar 17;18(18):1939-43. doi: 10.1016/s0264-410x(99)00446-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakub K Simon, MD, MS principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LectraJet, TIV by jet injection and Seasonal Trivalent Influenza Vaccine in people with Healthy Adults, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (AE) and serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessment) (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987350, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.