Inactivated Influenza Via Jet Injection
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza, Human
- Sponsor
- PharmaJet, Inc.
- Enrollment
- 985
- Locations
- 3
- Primary Endpoint
- Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
Time Frame: 28 Days
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.
The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer.
Time Frame: 28 Days
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40.
Secondary Outcomes
- Percentage of Subjects With Solicited Local or Systemic Adverse Events(7 Days)
- Percentage of Subjects With Immediate Complaints(Day 0)
- Percentage of Subjects With Spontaneously Reported Adverse Events(28 days)