Jet Injection for Influenza

NCT01688921 | Completed Phase 4 Results

• 1 other identifier: PJ-501-12-2
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine if the administration of a seasonal flu vaccine using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and syringe administration, as measured by laboratory tests of immune response.

Conditions

Influenza, Human

Keywords

Injections, Jet; Influenza Vaccines

Outcome Measures

Primary Outcomes (6)

• Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)

  The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.

  28 days

• Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)

  The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.

  28 days

• Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)

  The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.

  28 days

• Anti Influenza Type A/H1N1 Seroconversion

  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

• Anti Influenza Type A/H3N2 Seroconversion

  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

• Anti Influenza Type B Seroconversion

  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 Outcomes (4)

• Number of Subjects With Complaints Within 30 Minutes Following Vaccination

  Within 30 minutes post-vaccination

• Number of Subjects With Vaccine Reactogenicity Events

  Day 0, 1, 2, 3, 4, 5, and 6

• Number of Subjects With Spontaneously Reported Adverse Events

  28 days

• Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again

  28 Days

Study Arms (2)

STRATIS Needle-Free

EXPERIMENTAL

Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device.

Biological: AFLURIA vaccine (2012-2013 formulation); Device: Needle-Syringe; Device: Stratis needle-free injection device

Needle-Syringe

ACTIVE COMPARATOR

Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.

Biological: AFLURIA vaccine (2012-2013 formulation); Device: Needle-Syringe; Device: Stratis needle-free injection device

Interventions

AFLURIA vaccine (2012-2013 formulation) BIOLOGICAL

Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.

Also known as: trivalent inactivated influenza vaccine (TIV), influenza virus vaccine

Needle-Syringe; STRATIS Needle-Free

Needle-Syringe DEVICE

Needle-Syringe; STRATIS Needle-Free

Stratis needle-free injection device DEVICE

Needle-Syringe; STRATIS Needle-Free

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged ≥18 and ≤64 years of age at the time of enrollment
• Willing and able to give informed consent after reading the consent form and 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 TIV influenza vaccine, based on University of Colorado Health (UCH) employee health flu screening guidelines.
• Access to a consistent means of telephone contact

You may not qualify if:

• 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.
• Any immunosuppressive condition including: history of 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, gentamicin 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.

Sponsors & Collaborators

• PharmaJet, Inc.: lead

Study Sites (3)

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

University of Colorado Health Harmony Campus

Fort Collins, Colorado, 80528, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Related 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.

  PMID: 24881803 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Tara Miller, Clinical Affairs Manager
• Organization: PharmaJet, Inc.

tara.miller@pharmajet.com

888-900-4321

Study Officials

• David K Cobb, MD, MPH

  Rocky Mountain Infectious Disease Consultants

  PRINCIPAL INVESTIGATOR

• Linda McAllister, MD, PhD

  PharmaJet, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 1, 2017
• Results First Posted: October 22, 2014

Record last verified: 2017-09

Locations

US (3)