NCT02290691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
985

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

November 30, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

November 11, 2014

Results QC Date

April 12, 2016

Last Update Submit

November 16, 2017

Conditions

Influenza, Human

Keywords

Needle Free, Influenza

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Percentage of Subjects With Immediate Complaints

    Day 0

  • Percentage of Subjects With Solicited Local or Systemic Adverse Events

    7 Days

  • Percentage of Subjects With Spontaneously Reported Adverse Events

    28 days

Study Arms (2)

Needle- Free

EXPERIMENTAL

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

Biological: Influenza Vaccine

Needle and Syringe

ACTIVE COMPARATOR

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

Biological: Influenza Vaccine

Interventions

Influenza VaccineBIOLOGICAL

Influenza Vaccine

Needle and SyringeNeedle- Free

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Optimal Research LLC

Huntsville, Alabama, 35802, United States

Location

Optimal Research, LLC

San Diego, California, 92108, United States

Location

Optimal Research, LLC

Melbourne, Florida, 32934, United States

Location

Optimal Research, LLC

Peoria, Illinois, 64614, United States

Location

Optimal Reserach, LLC

Mishawaka, Indiana, 46545, United States

Location

Optimal Research, LLC

Rockville, Maryland, 20850, 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: 24881803BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Tara Miller, MS, Clinical Affairs Manager
Organization
PharmaJet, Inc
tara.miller@pharmajet.com
888-900-4321

Study Officials

  • William Gannon, MD

    PharmaJet, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
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

November 11, 2014

First Posted

November 14, 2014

Study Start

November 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 30, 2017

Results First Posted

November 30, 2017

Record last verified: 2017-11

Locations

US(6)