Jet Injection for Influenza

Study Overview
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Brief Summary
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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.

Official Title
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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
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Influenza, Human

Intervention / Treatment
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* Biological: AFLURIA vaccine (2012-2013 formulation)
* Device: Needle-Syringe
* Device: Stratis needle-free injection device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STRATIS Needle-Free<br>Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device. | Biological: AFLURIA vaccine (2012-2013 formulation)<br>* Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.<br>* Other names: influenza virus vaccine;Device: Needle-Syringe<br> <br> Device: Stratis needle-free injection device<br> <br> |
| Active Comparator: Needle-Syringe<br>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. | Biological: AFLURIA vaccine (2012-2013 formulation)<br>* Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.<br>* Other names: influenza virus vaccine;Device: Needle-Syringe<br> <br> Device: Stratis needle-free injection device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Complaints Within 30 Minutes Following Vaccination |  | 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. | 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. | 28 days | 
| Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again |  | 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injections, Jet, Influenza Vaccines