Jet Injection for Influenza

NCT ID: NCT01688921

Last Updated: 2017-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-03-31

Brief 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.

Conditions

Influenza, Human

Keywords

Injections, Jet; Influenza Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

STRATIS Needle-Free

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

Group Type: EXPERIMENTAL

AFLURIA vaccine (2012-2013 formulation)

Intervention Type: BIOLOGICAL

Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.

Needle-Syringe

Intervention Type: DEVICE

Stratis needle-free injection device

Intervention Type: DEVICE

Needle-Syringe

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

Group Type: ACTIVE_COMPARATOR

AFLURIA vaccine (2012-2013 formulation)

Intervention Type: BIOLOGICAL

Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.

Needle-Syringe

Intervention Type: DEVICE

Stratis needle-free injection device

Intervention Type: DEVICE

Interventions

AFLURIA vaccine (2012-2013 formulation)

Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.

Intervention Type: BIOLOGICAL

Needle-Syringe

Intervention Type: DEVICE

Stratis needle-free injection device

Intervention Type: DEVICE

Other Intervention Names

trivalent inactivated influenza vaccine (TIV); influenza virus vaccine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PharmaJet, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David K Cobb, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Infectious Disease Consultants

Linda McAllister, MD, PhD

Role: STUDY_DIRECTOR

PharmaJet, Inc.

Locations

Poudre Valley Hospital

Fort Collins, Colorado, United States

University of Colorado Health Harmony Campus

Fort Collins, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24881803 (View on PubMed)

Other Identifiers

PJ-501-12-2

Identifier Type: -

Identifier Source: org_study_id