Influenza ProphylaxisPhase 4NCT01644149
Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
A Phase 4 study testing Stratis Jet Injector, Needle and Syringe and 2011-2012 Fluzone trivalent inactivated influenza vaccine in people with Influenza Prophylaxis, run by PharmaJet, Inc. at 1 site in United States.
Trial summary
The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Prophylaxis
- What is being tested?
- Stratis Jet Injector, Needle and Syringe and 2011-2012 Fluzone trivalent inactivated 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
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female and male subjects ages 18 to 59 years
- Healthy volunteers
- Able to provide informed consent and understand study procedures per ICH/GCP guidelines
- Plans to remain in study area for length of the trial; able to adhere to study visit and follow-up schedule
- Able to complete study diary
Who cannot join
- Unwilling or unable to undergo the two blood draws per protocol
- Have received influenza vaccination in the last twelve months
- Have received any vaccination in the last month
- Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other immunosuppressive drugs
- Received recent blood, blood products, or parenteral preparations of immunoglobulin (within 3 months)
- Suffers from allergic reactions to egg, gelatin, or neomycin or has a history of anaphylactic shock, asthma, urticaria, or other allergic reactions to vaccinations.
Show all 11Show fewer
- Had any serious adverse event associated with a prior vaccination
- Has immunodeficiency or autoimmune disease (including HIV)
- History of chronic alcohol abuse
- Participating in another study concurrently
- Pregnant or breastfeeding during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial Assessing the Immunologic Response to an FDA-approved Influenza Vaccine Delivered Using an FDA-Cleared Jet Injection Vaccine Delivery Device or a Needle and Syringe
The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.
Read the detailed description
Needle-free jet injection devices create a fine stream of pressurized liquid that is able to deliver vaccines and other pharmaceutical products beneath the skin. Design aspects such as quality, pressure, orifice size, angle of injection relative to skin and injection stream coherence control the depth to which the product is delivered. This technology provides a safer delivery option for patients and healthcare staff by removing the need for needles for the administration of vaccines.
In addition to improved safety, additional benefits of using jet injectors include more consistent and reliable dose volume delivery, reduced vaccine waste, diminished need to transport large quantities of sharps, reduced risk of needle sticks, syringe reuse, and costs associated with sharps waste. Jet injectors offer a needle-free procedure to those individuals who are adverse to needles.
This study compared the efficacy of a disposable syringe jet injection device (Stratis) with traditional needle and syringe (NS) administration for the delivery of a trivalent inactivated influenza vaccine. Efficacy was evaluated by comparing measures of hemagglutination inhibition (HI); specifically GMTs, seroconversion and seroprotection. Safety of the two administration devices was evaluated by comparison of incidence of solicited local and systemic adverse events.
- Conditions
- Influenza Prophylaxis
- Being tested
- Stratis Jet Injector, Needle and Syringe, 2011-2012 Fluzone trivalent inactivated influenza vaccine
- Keywords
- Jet Injector, Stratis®, PharmaJet, Jet Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratis Jet InjectorDevice
Also called Jet Injector, Disposable Syringe Jet Injector, DSJI
Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
Needle and SyringeDevice
Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
2011-2012 Fluzone trivalent inactivated influenza vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Stratis Jet Injector | Experimental | Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector Receives: Device: Stratis Jet Injector; Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine |
| Needle and Syringe | Active comparator | Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe Receives: Device: Needle and Syringe; Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.
Measured: 28 days
The Percentage of Participants Achieving Seroconversion
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.
Measured: 28 days
Secondary outcomes (1)
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site tenderness, injection site pain, injection site redness, injection site swelling, injection site itching, injection site bruising, fatigue, muscle aches, headache, decreased appetite, fever, pruritus.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza ProphylaxisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaJet, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Perlman, MD, MBA, Principal investigator, Bel-Rea Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644149
- Sponsor's protocol ID
- PJ-500-07
- Status last verified
- Jun 2019
- First submitted
- 16 Jul 2012
- Last updated
- 20 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Assessing the Immunologic Response to an FDA-approved Influenza Vaccine Delivered Using an FDA-Cleared Jet Injection Vaccine Delivery Device or a Needle and Syringe
- ClinicalTrials.gov ID
- NCT01644149
- Acronym / sponsor ID
- PJ-500-07
- Conditions
- Influenza Prophylaxis
- Keywords
- Jet Injector, Stratis®, PharmaJet, Jet Injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- PharmaJet, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Posted 20 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.
Detailed description
Needle-free jet injection devices create a fine stream of pressurized liquid that is able to deliver vaccines and other pharmaceutical products beneath the skin. Design aspects such as quality, pressure, orifice size, angle of injection relative to skin and injection stream coherence control the depth to which the product is delivered. This technology provides a safer delivery option for patients and healthcare staff by removing the need for needles for the administration of vaccines.
In addition to improved safety, additional benefits of using jet injectors include more consistent and reliable dose volume delivery, reduced vaccine waste, diminished need to transport large quantities of sharps, reduced risk of needle sticks, syringe reuse, and costs associated with sharps waste. Jet injectors offer a needle-free procedure to those individuals who are adverse to needles.
This study compared the efficacy of a disposable syringe jet injection device (Stratis) with traditional needle and syringe (NS) administration for the delivery of a trivalent inactivated influenza vaccine. Efficacy was evaluated by comparing measures of hemagglutination inhibition (HI); specifically GMTs, seroconversion and seroprotection. Safety of the two administration devices was evaluated by comparison of incidence of solicited local and systemic adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratis Jet Injector | Experimental | Device: Stratis Jet Injector, Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccineSingle intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector |
| Needle and Syringe | Active comparator | Device: Needle and Syringe, Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccineSingle intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female and male subjects ages 18 to 59 years
- Healthy volunteers
- Able to provide informed consent and understand study procedures per ICH/GCP guidelines
- Plans to remain in study area for length of the trial; able to adhere to study visit and follow-up schedule
- Able to complete study diary
Key exclusion criteria (11 listed)
- Unwilling or unable to undergo the two blood draws per protocol
- Have received influenza vaccination in the last twelve months
- Have received any vaccination in the last month
- Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other immunosuppressive drugs
- Received recent blood, blood products, or parenteral preparations of immunoglobulin (within 3 months)
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 |
|---|---|---|
| Stratis Jet InjectorAlso: Jet Injector, Disposable Syringe Jet Injector, DSJIIntramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine | Device | Stratis Jet Injector |
| Needle and SyringeIntramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine | Device | Needle and Syringe |
| 2011-2012 Fluzone trivalent inactivated influenza vaccine | Biological | Needle and Syringe, Stratis Jet Injector |
Primary outcome
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
Time frame: 28 days
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.
The Percentage of Participants Achieving Seroconversion
Time frame: 28 days
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.
1 secondary outcome
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Time frame: 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel Perlman, MD, MBA principal investigator
Bel-Rea Institute
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 Stratis Jet Injector, Needle and Syringe and 2011-2012 Fluzone trivalent inactivated influenza vaccine in people with Influenza Prophylaxis, run by PharmaJet, Inc. 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 5 inclusion and 11 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 20 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2019.