NCT01644149

Brief Summary

The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

January 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

June 20, 2019

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

July 16, 2012

Results QC Date

May 1, 2019

Last Update Submit

June 18, 2019

Conditions

Influenza Prophylaxis

Keywords

Jet InjectorStratis®PharmaJetJet Injection

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 Percentage of Participants Achieving 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 (1)

  • Percentage of Subjects With Solicited Local or Systemic Adverse Events

    4 days

Study Arms (2)

Stratis Jet Injector

EXPERIMENTAL

Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector

Device: Stratis Jet InjectorBiological: 2011-2012 Fluzone trivalent inactivated influenza vaccine

Needle and Syringe

ACTIVE COMPARATOR

Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe

Device: Needle and SyringeBiological: 2011-2012 Fluzone trivalent inactivated influenza vaccine

Interventions

Stratis Jet InjectorDEVICE

Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine

Also known as: Jet Injector, Disposable Syringe Jet Injector, DSJI
Stratis Jet Injector
Needle and SyringeDEVICE

Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine

Needle and Syringe
2011-2012 Fluzone trivalent inactivated influenza vaccineBIOLOGICAL
Needle and SyringeStratis Jet Injector

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female and male subjects ages 18 to 59 years
  • Healthy volunteers
  • Able to provide informed consent and understand study procedures per ICH/GCP guidelines
  • Plans to remain in study area for length of the trial; able to adhere to study visit and follow-up schedule
  • Able to complete study diary

You may not qualify if:

  • Unwilling or unable to undergo the two blood draws per protocol
  • Have received influenza vaccination in the last twelve months
  • Have received any vaccination in the last month
  • Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other immunosuppressive drugs
  • Received recent blood, blood products, or parenteral preparations of immunoglobulin (within 3 months)
  • Suffers from allergic reactions to egg, gelatin, or neomycin or has a history of anaphylactic shock, asthma, urticaria, or other allergic reactions to vaccinations.
  • Had any serious adverse event associated with a prior vaccination
  • Has immunodeficiency or autoimmune disease (including HIV)
  • History of chronic alcohol abuse
  • Participating in another study concurrently
  • Pregnant or breastfeeding during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bel-Rea Institute

Denver, Colorado, 80247, United States

Location

MeSH Terms

Interventions

NeedlesSyringes

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

Title
Marilyn Dysart, Clinical Affairs Manager
Organization
PharmaJet, Inc.
marilyn.dysart@pharmajet.com
720-214-9399

Study Officials

  • Daniel Perlman, MD, MBA

    Bel-Rea Institute

    PRINCIPAL INVESTIGATOR

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

July 16, 2012

First Posted

July 18, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

June 20, 2019

Results First Posted

June 20, 2019

Record last verified: 2019-06

Locations

US(1)