Inactivated Influenza Via Jet Injection (IIJI)

• 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: PharmaJet, Inc.
• Information provided by (Responsible Party): PharmaJet, Inc.

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: William Gannon, MD; PharmaJet, Inc.

More Information

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.

• Responsible Party: PharmaJet, Inc.
• ClinicalTrials.gov Identifier: NCT02290691
• Other Study ID Numbers: PJ-501-14
• First Posted: November 14, 2014
• 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:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases