Jet Injection for Influenza (JIFI)

PharmaJet

Status and phase: Completed; Phase 4

Conditions: Influenza, Human

Treatments: Biological: AFLURIA vaccine (2012-2013 formulation); Device: Stratis needle-free injection device; Device: Needle-Syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT01688921

PJ-501-12-2

Details and patient eligibility

About

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.

Enrollment: 1,250 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,250 participants in 2 patient groups

STRATIS Needle-Free

Experimental group

Description:

Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device.

Treatment:

Device: Needle-Syringe

Device: Stratis needle-free injection device

Biological: AFLURIA vaccine (2012-2013 formulation)

Needle-Syringe

Active Comparator group

Description:

Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.

Treatment:

Device: Needle-Syringe

Device: Stratis needle-free injection device

Biological: AFLURIA vaccine (2012-2013 formulation)