Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Needle-free jet injection devices create a fine stream of pressurized liquid that is able to deliver vaccines and other pharmaceutical products beneath the skin. Design aspects such as quality, pressure, orifice size, angle of injection relative to skin and injection stream coherence control the depth to which the product is delivered. This technology provides a safer delivery option for patients and healthcare staff by removing the need for needles for the administration of vaccines.
In addition to improved safety, additional benefits of using jet injectors include more consistent and reliable dose volume delivery, reduced vaccine waste, diminished need to transport large quantities of sharps, reduced risk of needle sticks, syringe reuse, and costs associated with sharps waste. Jet injectors offer a needle-free procedure to those individuals who are adverse to needles.
This study compared the efficacy of a disposable syringe jet injection device (Stratis) with traditional needle and syringe (NS) administration for the delivery of a trivalent inactivated influenza vaccine. Efficacy was evaluated by comparing measures of hemagglutination inhibition (HI); specifically GMTs, seroconversion and seroprotection. Safety of the two administration devices was evaluated by comparison of incidence of solicited local and systemic adverse events.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratis Jet Injector | Experimental | Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector |
|
| Needle and Syringe | Active Comparator | Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stratis Jet Injector | Device | Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 tenderness, injection site pain, injection site redness, injection site swelling, injection site itching, injection site bruising, fatigue, muscle aches, headache, decreased appetite, fever, pruritus. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Perlman, MD, MBA | Bel-Rea Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bel-Rea Institute | Denver | Colorado | 80247 | United States |
A total of 83 subjects were recruited and 78 (39 Stratis® and 39 NS) completed the study. One Stratis® group subject (subject # 23) discontinued from the study prior to vaccination.
Up to 100 subjects between the ages of 18 and 59 were planned with 83 subjects enrolled and 82 subjects vaccinated. Pre- and post-vaccination serum samples were collected from 78 subjects and were analyzed in the Efficacy population.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stratis Jet Injector | Patients assigned to this arm will receive Fluzone trivalent inactivated influenza vaccine administered using the STRATIS needle-free injection device. Fluzone vaccine (2011-2012 formulation): Patients will receive a single intramuscular injection of 0.5 ml of Fluzone vaccine in the deltoid region. STRATIS needle-free injection device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Needle and Syringe | Device | Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine |
|
| 2011-2012 Fluzone trivalent inactivated influenza vaccine | Biological |
|
| 4 days |
| FG001 |
| Needle-Syringe |
Patients assigned to this arm will receive Fluzone trivalent inactivated influenza vaccine administered using a needle and syringe. Fluzone vaccine (2011-2012 formulation): Patients will receive a single intramuscular injection of 0.5 ml of Fluzone vaccine in the deltoid region. Needle-Syringe |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PharmaJet Stratis Injector | Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector Stratis Jet Injector: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine 2011-2012 Fluzone trivalent inactivated influenza vaccine |
| BG001 | Needle and Syringe | Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe Needle and Syringe: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine 2011-2012 Fluzone trivalent inactivated influenza vaccine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The immunogenicity analyses were conducted using data from subjects in the immunogenicity population. | Posted | Geometric Mean | Standard Deviation | Titers | 28 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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. | Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Immunogenicity Population. | Posted | Number | Percentage of Subjects Seroconverted | 28 days |
|
| |||||||||||||||||||||||||||||||||||||
| 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 tenderness, injection site pain, injection site redness, injection site swelling, injection site itching, injection site bruising, fatigue, muscle aches, headache, decreased appetite, fever, pruritus. | Data included in the analysis were collected on a 4-Day Diary Card from the safety population and grade >1. | Posted | Number | Percentage of Subjects | 4 days |
|
Complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site. Local and systemic study injection reactions were monitored for 4 days post injection.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 4-Day Diary Card.
The denominators were determined for each individual AE for each summary window (Day 0-4). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PharmaJet Stratis Injector | Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector Stratis Jet Injector: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine 2011-2012 Fluzone trivalent inactivated influenza vaccine | 0 | 39 | 36 | 39 | ||
| EG001 | Needle and Syringe | Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe Needle and Syringe: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine 2011-2012 Fluzone trivalent inactivated influenza vaccine | 0 | 39 | 32 | 39 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tenderness | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local Adverse Reaction within 4 days of vaccination and Grade of >=1 |
|
| Pain | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local symptoms at injection site within 4 days of vaccination with Grade of >=1 |
|
| Redness | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local event occurring within 4 days of vaccination and Grade of >=1 |
|
| Swelling | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local event occurring within 4 days of vaccination and Grade of >=1 |
|
| Itching | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local event occurring within 4 days of vaccination and Grade of >=1 |
|
| Bruising | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local event occurring within 4 days of vaccination and Grade of >=1 |
|
| Fatigue | Immune system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Muscle Aches | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Decreased Appetite | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Fever | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marilyn Dysart, Clinical Affairs Manager | PharmaJet, Inc. | 720-214-9399 | marilyn.dysart@pharmajet.com |
| ID | Term |
|---|---|
| D009339 | Needles |
| D013594 | Syringes |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| Hispanic or Latino |
|
| American Indian or Alaska Native |
|
| A/ H3N2 Day 0 |
|
| A/H3N2 Day 28 |
|
| B Day 0 |
|
| B Day 28 |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|