Clinical trial NCT01688921: Jet Injection for Influenza
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Keywords: Injections, Jet
Influenza Vaccines
Lead sponsor: PharmaJet, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 1250
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 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.


Eligibility 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 University of Colorado Health (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.

Primary outcomes:
measure: Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
timeFrame: 28 days
measure: Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
timeFrame: 28 days
measure: Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
timeFrame: 28 days
measure: Anti Influenza Type A/H1N1 Seroconversion
timeFrame: 28 days
measure: Anti Influenza Type A/H3N2 Seroconversion
timeFrame: 28 days
measure: Anti Influenza Type B Seroconversion
timeFrame: 28 days
Secondary outcomes:
measure: Number of Subjects With Complaints Within 30 Minutes Following Vaccination
timeFrame: Within 30 minutes post-vaccination
measure: Number of Subjects With Vaccine Reactogenicity Events
timeFrame: Day 0, 1, 2, 3, 4, 5, and 6
measure: Number of Subjects With Spontaneously Reported Adverse Events
timeFrame: 28 days
measure: Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again
timeFrame: 28 Days
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Fort Collins
country: United States
facility: University of Colorado Health Harmony Campus
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
affiliation: Rocky Mountain Infectious Disease Consultants
name: David K Cobb, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: PharmaJet, Inc.
name: Linda McAllister, MD, PhD
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.