Influenza, HumanPhase 4JIFINCT01688921

Jet Injection for Influenza

A Phase 4 study testing AFLURIA vaccine (2012-2013 formulation), Needle-Syringe and Stratis needle-free injection device in people with Influenza, Human, run by PharmaJet, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if the administration of a seasonal flu vaccine using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and syringe administration, as measured by laboratory tests of immune response. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: AFLURIA vaccine (2012-2013 formulation), Needle-Syringe and Stratis needle-free injection device
Type of treatment: Vaccines, Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,250 participants
Where: 3 sitesUnited States
Study dates: Oct 2012to Mar 2013
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 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Adults aged ≥18 and ≤64 years of age at the time of enrollment
Willing and able to give informed consent after reading the consent form and adequate opportunity to discuss the study with the investigator or qualified designee
Willing and able to adhere to all protocol required study procedures and to attend scheduled visits.
Able to receive the TIV influenza vaccine, based on University of Colorado Health (UCH) employee health flu screening guidelines.
Stable health status with no exclusionary medical or neuropsychiatric conditions as determined during the screening evaluation and based on the clinical judgment of the investigator or qualified designee.
Access to a consistent means of telephone contact

Who cannot join

Presence of any febrile illness (oral temperature >38°C) on the day of immunization. Such subjects will be reevaluated for enrollment after resolution of illness.
Presence of significant acute or chronic uncontrolled medical or neuropsychiatric illness and /or presence of any significant condition that may prohibit inclusion as determined by the investigator or his qualified designee. Uncontrolled is defined as: requiring institution of a new treatment within 1 month prior to study enrollment or change in medication dosage in the month prior to study enrollment.
Any immunosuppressive condition including: history of HIV infection, cancer or cancer treatment within 3 years of study enrollment, systemic glucocorticoids (in a dose ≥10 mg prednisone daily or equivalent for more than 7 consecutive days or for 10 or more days in total) within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 3 months of study enrollment. Any significant disorder of coagulation that would increase the risk of intramuscular injections or treatment with Coumadin derivatives or heparin.
Known or suspected to be allergic to eggs, chicken protein, gentamicin or influenza vaccine.
History of severe or previous serious adverse reaction after an influenza vaccination.
Receipt of any immunoglobulin and/or blood products within 3 months of immunization or planned administration of any of these products during the study period.

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Prior history of any demyelinating disease including Guillain-Barre syndrome.
Presence of an active neurological disorder.
History of significant alcohol or drug abuse within one year prior to study enrollment.
Influenza vaccination or laboratory confirmed influenza infection within the previous six months before study vaccination or planned influenza vaccination during the study period.
Planned administration of any non-influenza vaccines 30 days prior to the study or during the study period.
Pregnant or plans to become pregnant during the study period.
Currently enrolled in another vaccine or drug study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Poudre Valley Hospital
Fort Collins, Colorado, 80524
University of Colorado Health Harmony Campus
Fort Collins, Colorado, 80528
Medical Center of the Rockies
Loveland, Colorado, 80538

Other trials in United States

About this study

Official title: Jet Injection for Influenza: A Randomized Controlled Clinical Trial to Demonstrate Non Inferiority of Jet Injection vs. Needle and Syringe for Administration of Trivalent Inactivated Influenza Vaccine

Conditions: Influenza, Human
Being tested: AFLURIA vaccine (2012-2013 formulation), Needle-Syringe, Stratis needle-free injection device
Keywords: Injections, Jet, Influenza Vaccines
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AFLURIA vaccine (2012-2013 formulation)Biological
Also called trivalent inactivated influenza vaccine (TIV), influenza virus vaccine
Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Needle-SyringeDevice
Stratis needle-free injection deviceDevice

Study groups in NCT01688921
Study group	Role	What they receive
STRATIS Needle-Free	Experimental	Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device. Receives: Biological: AFLURIA vaccine (2012-2013 formulation); Device: Needle-Syringe; Device: Stratis needle-free injection device
Needle-Syringe	Active comparator	Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. Receives: Biological: AFLURIA vaccine (2012-2013 formulation); Device: Needle-Syringe; Device: Stratis needle-free injection device

What is being measured

The primary outcome is the main question the study is designed to answer.

Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.
Measured: 28 days
Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.
Measured: 28 days
Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.
Measured: 28 days
Anti Influenza Type A/H1N1 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
Anti Influenza Type A/H3N2 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
Anti Influenza Type B 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 (4)

Number of Subjects With Complaints Within 30 Minutes Following Vaccination
Measured: Within 30 minutes post-vaccination
Number of Subjects With Vaccine Reactogenicity Events
Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.
Measured: Day 0, 1, 2, 3, 4, 5, and 6
Number of Subjects With Spontaneously Reported Adverse Events
Subjects will be asked to report any other symptoms experienced in addition to the solicited "immediate" and "vaccine reactogenicity" events. Any other events reported will be tabulated as spontaneously reported adverse events.
Measured: 28 days
Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again
Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Mar 2013

First posted20 Sep 2012 (estimated)
Study startOct 2012
Primary completionMar 2013
Study completionMar 2013

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influenza, HumanStudies 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: 1,250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01688921
Sponsor's protocol ID: PJ-501-12-2
Acronym: JIFI
Status last verified: Sep 2017
First submitted: 17 Sep 2012
Last updated: 1 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

McAllister L, Anderson J, Werth K, Cho I, Copeland K, Le Cam Bouveret N, Plant D, Mendelman PM, Cobb DK. Needle-free jet injection for administration of influenza vaccine: a randomised non-inferiority trial. Lancet. 2014 Aug 23;384(9944):674-81. doi: 10.1016/S0140-6736(14)60524-9. Epub 2014 May 31.
PubMed 24881803

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza, Human trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Jet Injection for Influenza: A Randomized Controlled Clinical Trial to Demonstrate Non Inferiority of Jet Injection vs. Needle and Syringe for Administration of Trivalent Inactivated Influenza Vaccine
ClinicalTrials.gov ID: NCT01688921
Acronym / sponsor ID: JIFI / PJ-501-12-2
Conditions: Influenza, Human
Keywords: Injections, Jet, Influenza Vaccines
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,250 participants (actual)
Lead sponsor: PharmaJet, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 20 Sep 2012 (estimated)
Results: Posted 22 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
STRATIS Needle-Free	Experimental	Biological: AFLURIA vaccine (2012-2013 formulation), Device: Needle-Syringe, Device: Stratis needle-free injection devicePatients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device.
Needle-Syringe	Active comparator	Biological: AFLURIA vaccine (2012-2013 formulation), Device: Needle-Syringe, Device: Stratis needle-free injection devicePatients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Adults aged ≥18 and ≤64 years of age at the time of enrollment
Willing and able to give informed consent after reading the consent form and adequate opportunity to discuss the study with the investigator or qualified designee
Willing and able to adhere to all protocol required study procedures and to attend scheduled visits.
Able to receive the TIV influenza vaccine, based on University of Colorado Health (UCH) employee health flu screening guidelines.
Stable health status with no exclusionary medical or neuropsychiatric conditions as determined during the screening evaluation and based on the clinical judgment of the investigator or qualified designee.

Key exclusion criteria (13 listed)

Presence of any febrile illness (oral temperature >38°C) on the day of immunization. Such subjects will be reevaluated for enrollment after resolution of illness.
Presence of significant acute or chronic uncontrolled medical or neuropsychiatric illness and /or presence of any significant condition that may prohibit inclusion as determined by the investigator or his qualified designee. Uncontrolled is defined as: requiring institution of a new treatment within 1 month prior to study enrollment or change in medication dosage in the month prior to study enrollment.
Any immunosuppressive condition including: history of HIV infection, cancer or cancer treatment within 3 years of study enrollment, systemic glucocorticoids (in a dose ≥10 mg prednisone daily or equivalent for more than 7 consecutive days or for 10 or more days in total) within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 3 months of study enrollment. Any significant disorder of coagulation that would increase the risk of intramuscular injections or treatment with Coumadin derivatives or heparin.
Known or suspected to be allergic to eggs, chicken protein, gentamicin or influenza vaccine.
History of severe or previous serious adverse reaction after an influenza vaccination.

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
AFLURIA vaccine (2012-2013 formulation)Also: trivalent inactivated influenza vaccine (TIV), influenza virus vaccinePatients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.	Biological	Needle-Syringe, STRATIS Needle-Free
Needle-Syringe	Device	Needle-Syringe, STRATIS Needle-Free
Stratis needle-free injection device	Device	Needle-Syringe, STRATIS Needle-Free

Primary outcome

Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (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 NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.
Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (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 NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.
Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (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 NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.
Anti Influenza Type A/H1N1 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.
Anti Influenza Type A/H3N2 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.
Anti Influenza Type B 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.

4 secondary outcomes

Number of Subjects With Complaints Within 30 Minutes Following Vaccination
Time frame: Within 30 minutes post-vaccination
Number of Subjects With Vaccine Reactogenicity Events
Time frame: Day 0, 1, 2, 3, 4, 5, and 6
Number of Subjects With Spontaneously Reported Adverse Events
Time frame: 28 days
Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again
Time frame: 28 Days

Results and safety

Results posted to the registry on 22 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
STRATIS	627	611
Needle-Syringe	623	608

Primary outcome: Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)

Time frame: 28 days. Geometric mean (Standard Deviation). Unit: Titers

Measure	PJ STRATIS n = 562	Needle-Syringe n = 568
Day 0	4.43 (1.348)	4.38 (1.352)
Day 28	5.64 (1.006)	5.64 (0.997)

PJ STRATIS vs Needle-Syringe: Geometric Mean Ratio: 0.99 (95% CI 0.88 to 1.12)

Population analysed: The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.

Primary outcome: Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)

Time frame: 28 days. Geometric mean (Standard Deviation). Unit: Titers

Measure	PJ STRATIS n = 562	Needle-Syringe n = 568
Day 0	4.22 (1.283)	4.32 (1.290)
Day 28	5.51 (1.022)	5.58 (0.987)

PJ STRATIS vs Needle-Syringe: Geometric Mean Ratio: 1.08 (95% CI 0.96 to 1.21)

Population analysed: The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.

Primary outcome: Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)

Time frame: 28 days. Geometric mean (Standard Deviation). Unit: Titers

Measure	PJ STRATIS n = 562	Needle-Syringe n = 568
Day 0	2.60 (1.028)	2.54 (1.003)
Day 28	3.75 (1.037)	3.68 (1.061)

PJ STRATIS vs Needle-Syringe: Geometric Mean Ratio: 0.94 (95% CI 0.83 to 1.06)

Population analysed: The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.

Primary outcome: Anti Influenza Type A/H1N1 Seroconversion

Time frame: 28 days. Number. Unit: Percent of Participants

Measure	PJ STRATIS n = 562	Needle-Syringe n = 568
Value	37.5	38.4

PJ STRATIS vs Needle-Syringe: Seroconversion Rate Difference: 0.8 (95% CI -4.8 to 6.5)

Population analysed: The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
STRATIS	1 of 624 (0.2%)	586 of 624 (93.9%)	Not reported
Needle-Syringe	2 of 623 (0.3%)	516 of 623 (82.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24881803McAllister L, Anderson J, Werth K, Cho I, Copeland K, Le Cam Bouveret N, Plant D, Mendelman PM, Cobb DK. Needle-free jet injection for administration of influenza vaccine: a randomised non-inferiority trial. Lancet. 2014 Aug 23;384(9944):674-81. doi: 10.1016/S0140-6736(14)60524-9. Epub 2014 May 31.

Related trials for Influenza, Human

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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.

David K Cobb, MD, MPH principal investigator

Rocky Mountain Infectious Disease Consultants

Linda McAllister, MD, PhD study director

PharmaJet, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 22 Oct 2014). 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 Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) (time frame: 28 days). The study lists 6 primary outcomes in all. 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 NCT01688921, which also lists 1 linked publication.

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 1 Nov 2017.