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Inactivated Influenza Via Jet Injection (IIJI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290691
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
PharmaJet, Inc.

Brief Summary:
The purpose of this study is to determine if the administration of flu vaccine using Needle-Free is equivalent to Needle and Syringe administration as measured by laboratory tests of immune response.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: Influenza Vaccine Phase 4

Detailed Description:

Primary:

To evaluate the non-inferiority of flu vaccine administered by needle-free intramuscular (IM) injection versus needle and syringe IM injection as determined with serum hemagglutination inhibition (HAI) reciprocal titers in healthy adults between 18-64 years.

Secondary:

To compare tolerability and safety of the vaccine in the same population based on specifically solicited local and systemic reactions occurring through 7 days post-immunization and adverse events spontaneously reported through approximately 28 days post immunization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 985 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Inactivated Influenza Via Jet Injection
Study Start Date : November 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Needle- Free
Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.
Biological: Influenza Vaccine
Influenza Vaccine

Active Comparator: Needle and Syringe
Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.
Biological: Influenza Vaccine
Influenza Vaccine




Primary Outcome Measures :
  1. Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (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 Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.

  2. The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer. [ 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.


Secondary Outcome Measures :
  1. Percentage of Subjects With Immediate Complaints [ Time Frame: Day 0 ]
    The following possible immediate complaints will be solicited following the 30 minute safety observation period post-vaccination: local pain, redness, induration/swelling, itching where the injection was 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 will be recorded as an adverse event.

  2. Percentage of Subjects With Solicited Local or Systemic Adverse Events [ Time Frame: 7 Days ]
    vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site pain, injection site tenderness, injection site itching, injection site swelling, injection site redness, injection site bruising, fever, fatigue, headache, nausea, chills, muscle ache.

  3. Percentage of Subjects With Spontaneously Reported Adverse Events [ Time Frame: 28 days ]
    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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults aged ≥ 18 and ≤ 64 years of age at time of enrollment
  • Willing and able to give informed consent after reading the consent form and given 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 trivalent influenza vaccine (TIV) or quadrivalent influenza vaccine (QIV) based on PI judgment
  • 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 known immunosuppressive condition including: history of human immunodeficiency virus (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, neomycin, polymyxin 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290691


Locations
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United States, Alabama
Optimal Research LLC
Huntsville, Alabama, United States, 35802
United States, California
Optimal Research, LLC
San Diego, California, United States, 92108
United States, Florida
Optimal Research, LLC
Melbourne, Florida, United States, 32934
United States, Illinois
Optimal Research, LLC
Peoria, Illinois, United States, 64614
United States, Indiana
Optimal Reserach, LLC
Mishawaka, Indiana, United States, 46545
United States, Maryland
Optimal Research, LLC
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
PharmaJet, Inc.
Investigators
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Study Director: William Gannon, MD PharmaJet, Inc.
Publications:
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Responsible Party: PharmaJet, Inc.
ClinicalTrials.gov Identifier: NCT02290691    
Other Study ID Numbers: PJ-501-14
First Posted: November 14, 2014    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: November 2017
Keywords provided by PharmaJet, Inc.:
Needle Free, Influenza
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases