Inactivated Influenza Via Jet Injection

Influenza, Human Clinical Trial

— IIJI  

Official title:

Inactivated Influenza Via Jet Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290691
• Other study ID #: PJ-501-14
• Status: Completed
• Phase: Phase 4
• First received: November 11, 2014
• Last updated: November 16, 2017
• Start date: November 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2017
• Source: PharmaJet, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 985
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• Influenza Vaccine
Influenza Vaccine

Locations

Country	Name	City	State
United States	Optimal Research LLC	Huntsville	Alabama
United States	Optimal Research, LLC	Melbourne	Florida
United States	Optimal Reserach, LLC	Mishawaka	Indiana
United States	Optimal Research, LLC	Peoria	Illinois
United States	Optimal Research, LLC	Rockville	Maryland
United States	Optimal Research, LLC	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
PharmaJet, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)	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.	28 Days
Primary	The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer.	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.	28 Days
Secondary	Percentage of Subjects With Immediate Complaints	The following possible immediate complaints will be solicited following the 30 minute safety observation period post-vaccination: local pain, redness, induration/swelling, itching where the injection was given. The data will be reported as "immediate complaints" and presumed to be related to the test article. Any other symptom experienced at 30 minutes will be recorded as an adverse event.	Day 0
Secondary	Percentage of Subjects With Solicited Local or Systemic Adverse Events	vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site pain, injection site tenderness, injection site itching, injection site swelling, injection site redness, injection site bruising, fever, fatigue, headache, nausea, chills, muscle ache.	7 Days
Secondary	Percentage of Subjects With Spontaneously Reported Adverse Events	Subjects will be asked to report any other symptoms experienced in addition to the solicited "immediate" and "vaccine reactogenicity" events. Any other events reported will be tabulated as spontaneously reported adverse events.	28 days