Inactivated Influenza Via Jet Injection

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02290691
• Date of registration: 11/11/2014
• Prospective Registration: No
• Primary sponsor: PharmaJet, Inc.
• Public title: Inactivated Influenza Via Jet Injection IIJI
• Scientific title: Inactivated Influenza Via Jet Injection
• Date of first enrolment: November 2014
• Target sample size: 985
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02290691
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: William Gannon, MD
• Affiliation: PharmaJet, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza, Human

Intervention(s)

Biological: Influenza Vaccine

Primary Outcome(s)

Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) [Time Frame: 28 Days]

The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer. [Time Frame: 28 Days]

Secondary Outcome(s)

Percentage of Subjects With Immediate Complaints [Time Frame: Day 0]

Percentage of Subjects With Solicited Local or Systemic Adverse Events [Time Frame: 7 Days]

Percentage of Subjects With Spontaneously Reported Adverse Events [Time Frame: 28 days]

Secondary ID(s)

PJ-501-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02290691