Inactivated Influenza Via Jet Injection

NCT ID: NCT02290691

Last Updated: 2017-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 985 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-01-31

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.

Conditions

Influenza, Human

Keywords

Needle Free, Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Needle- Free

Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.

Group Type: EXPERIMENTAL

Influenza Vaccine

Intervention Type: BIOLOGICAL

Influenza Vaccine

Needle and Syringe

Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.

Group Type: ACTIVE_COMPARATOR

Influenza Vaccine

Intervention Type: BIOLOGICAL

Influenza Vaccine

Interventions

Influenza Vaccine

Influenza Vaccine

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PharmaJet, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Gannon, MD

Role: STUDY_DIRECTOR

PharmaJet, Inc.

Locations

Optimal Research LLC

Huntsville, Alabama, United States

Optimal Research, LLC

San Diego, California, United States

Optimal Research, LLC

Melbourne, Florida, United States

Optimal Research, LLC

Peoria, Illinois, United States

Optimal Reserach, LLC

Mishawaka, Indiana, United States

Optimal Research, LLC

Rockville, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24881803 (View on PubMed)

Other Identifiers

PJ-501-14

Identifier Type: -

Identifier Source: org_study_id