Status:
COMPLETED
Inactivated Influenza Via Jet Injection
Lead Sponsor:
PharmaJet, Inc.
Conditions:
Influenza, Human
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
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 inhib...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
985 Patients enrolled
Trial Details
Trial ID
NCT02290691
Start Date
November 1 2014
End Date
January 1 2015
Last Update
November 30 2017
Active Locations (6)
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1
Optimal Research LLC
Huntsville, Alabama, United States, 35802
2
Optimal Research, LLC
San Diego, California, United States, 92108
3
Optimal Research, LLC
Melbourne, Florida, United States, 32934
4
Optimal Research, LLC
Peoria, Illinois, United States, 64614