Clinical trial NCT02290691: Inactivated Influenza Via Jet Injection
Official title: Inactivated Influenza Via Jet Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Keywords: Needle Free, Influenza
Lead sponsor: PharmaJet, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 985
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
timeFrame: 28 Days
measure: The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer.
timeFrame: 28 Days
Secondary outcomes:
measure: Percentage of Subjects With Immediate Complaints
timeFrame: Day 0
measure: Percentage of Subjects With Solicited Local or Systemic Adverse Events
timeFrame: 7 Days
measure: Percentage of Subjects With Spontaneously Reported Adverse Events
timeFrame: 28 days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Optimal Research LLC
state: Alabama
city: San Diego
country: United States
facility: Optimal Research, LLC
state: California
city: Melbourne
country: United States
facility: Optimal Research, LLC
state: Florida
city: Peoria
country: United States
facility: Optimal Research, LLC
state: Illinois
city: Mishawaka
country: United States
facility: Optimal Reserach, LLC
state: Indiana
city: Rockville
country: United States
facility: Optimal Research, LLC
state: Maryland
Study officials:
affiliation: PharmaJet, Inc.
name: William Gannon, MD
role: STUDY_DIRECTOR
References:
citation: 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.