Inactivated Influenza Via Jet Injection (IIJI)

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: Influenza Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 985
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • Optimal Research LLC
  • California
    • San Diego, California, United States, 92108
      • Optimal Research, LLC
  • Florida
    • Melbourne, Florida, United States, 32934
      • Optimal Research, LLC
  • Illinois
    • Peoria, Illinois, United States, 64614
      • Optimal Research, LLC
  • Indiana
    • Mishawaka, Indiana, United States, 46545
      • Optimal Reserach, LLC
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Optimal Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)	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.	28 Days
The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer.	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
Percentage of Subjects With Immediate Complaints	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.	Day 0
Percentage of Subjects With Solicited Local or Systemic Adverse Events	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.	7 Days
Percentage 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

Collaborators and Investigators

• Sponsor: PharmaJet, Inc.
• Investigators: Study Director: William Gannon, MD, PharmaJet, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: November 11, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Needle Free, Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: PJ-501-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No