Inactivated Influenza Via Jet Injection (IIJI)

PharmaJet

Status and phase

Completed

Phase 4

Conditions

Influenza, Human

Treatments

Biological: Influenza Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02290691

PJ-501-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

985 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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