Jet Injection for Influenza (JIFI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PharmaJet, Inc.
ClinicalTrials.gov Identifier:
NCT01688921
First received: September 17, 2012
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Influenza, Human
Biological: AFLURIA vaccine (2012-2013 formulation)
Device: Needle-Syringe
Device: STRATIS needle-free injection device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by PharmaJet, Inc.:

Primary Outcome Measures:
  • Anti influenza type A/H1N1 Hemagglutination Inhibition (HAI) antibody Geometric Mean Titer (GMT) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Anti influenza type A/H3N2 HAI antibody GMT [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Anti influenza type B HAI antibody GMT [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Anti influenza type A/H1N1 seroconversion [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Proportion of subjects with immediate complaints [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    The following possible immediate complaints will be solicited following the 30 minute safety observation period post-vaccination: pain at injection site, tenderness at injection site, redness, induration/swelling (lump), bruising, itching where the injection is given. The data will be reported as "immediate complaints" and presumed to be related to the test article. Any other symptom experienced at 30 minutes is to be recorded as an adverse event.

  • Proportion of subjects with vaccine reactogenicity events [ Time Frame: Day 0, 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
    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.

  • Proportion of subjects with spontaneously reported adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1252
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STRATIS
Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.
Biological: AFLURIA vaccine (2012-2013 formulation)
Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Other Names:
  • trivalent inactivated influenza vaccine (TIV)
  • influenza virus vaccine
Device: STRATIS needle-free injection device
Active Comparator: Needle-Syringe
Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
Biological: AFLURIA vaccine (2012-2013 formulation)
Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Other Names:
  • trivalent inactivated influenza vaccine (TIV)
  • influenza virus vaccine
Device: Needle-Syringe

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688921

Locations
United States, Colorado
Poudre Valley Hospital
Ft. Collins, Colorado, United States, 80524
University of Colorado Health Harmony Campus
Ft. Collins, Colorado, United States, 80528
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Sponsors and Collaborators
PharmaJet, Inc.
Investigators
Principal Investigator: David K Cobb, MD, MPH Rocky Mountain Infectious Disease Consultants
Study Director: Linda McAllister, MD, PhD PharmaJet, Inc.
  More Information

No publications provided

Responsible Party: PharmaJet, Inc.
ClinicalTrials.gov Identifier: NCT01688921     History of Changes
Other Study ID Numbers: PJ-501-12-2
Study First Received: September 17, 2012
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by PharmaJet, Inc.:
Injections, Jet
Influenza Vaccines

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014