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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STRATIS Needle-Free | Experimental | Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device. |
|
| Needle-Syringe | Active Comparator | Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFLURIA vaccine (2012-2013 formulation) | Biological | Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Complaints Within 30 Minutes Following Vaccination | Within 30 minutes post-vaccination | |
| Number of Subjects With Vaccine Reactogenicity Events | Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David K Cobb, MD, MPH | Rocky Mountain Infectious Disease Consultants | Principal Investigator |
| Linda McAllister, MD, PhD | PharmaJet, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States | ||
| University of Colorado Health Harmony Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24881803 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | STRATIS | Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. STRATIS needle-free injection device |
| FG001 | Needle-Syringe | Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Three subjects randomized to the PJ Stratis arm did not have properly documented informed consent and were excluded from the Full Analysis Set (FAS).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | STRATIS | Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. STRATIS needle-free injection device |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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. | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Posted | Geometric Mean | Standard Deviation | Titers | 28 days |
|
Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site.
Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card.
The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). 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 | STRATIS | Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. STRATIS needle-free injection device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal Ulcer Perforation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment | The SAE was unrelated to subject's participation in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local symptoms at injection site within 6 days of vaccination with Grade of >=1 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara Miller, Clinical Affairs Manager | PharmaJet, Inc. | 888-900-4321 | 4163 | tara.miller@pharmajet.com |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Needle-Syringe | Device |
|
| Stratis needle-free injection device | Device |
|
| 28 days |
| Day 0, 1, 2, 3, 4, 5, and 6 |
| Number of Subjects With Spontaneously Reported Adverse Events | Subjects will be asked to report any other symptoms experienced in addition to the solicited "immediate" and "vaccine reactogenicity" events. Any other events reported will be tabulated as 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 |
| Fort Collins |
| Colorado |
| 80528 |
| United States |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Protocol Violation |
|
| informed consent |
|
| Needle-Syringe |
Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Needle-Syringe |
Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe |
|
|
|
| Primary | 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. | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Posted | Geometric Mean | Standard Deviation | Titers | 28 days |
|
|
|
|
| Primary | 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. | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Posted | Geometric Mean | Standard Deviation | Titers | 28 days |
|
|
|
|
| Primary | 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. | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Posted | Number | Percent of Participants | 28 days |
|
|
|
|
| Primary | 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. | Posted | Number | Percent of Participants | 28 days |
|
|
|
|
| Primary | 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. | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Posted | Number | Percent of Participants | 28 days |
|
|
|
|
| Secondary | Number of Subjects With Complaints Within 30 Minutes Following Vaccination | The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). | Posted | Number | participants | Within 30 minutes post-vaccination |
|
|
|
|
| Secondary | Number of Subjects With Vaccine Reactogenicity Events | Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening. | The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). Eight subjects (624-616) in the PJ Stratis group and 16 (623-607) in the NS group did not return the 7-Day Diary Card. | Posted | Number | participants | Day 0, 1, 2, 3, 4, 5, and 6 |
|
|
|
|
| Secondary | Number of Subjects With Spontaneously Reported Adverse Events | Subjects will be asked to report any other symptoms experienced in addition to the solicited "immediate" and "vaccine reactogenicity" events. Any other events reported will be tabulated as spontaneously reported adverse events. | The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). | Posted | Number | participants with spontaneous AEs | 28 days |
|
|
|
| Secondary | Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again | Safety population | Posted | Number | Percent of Participants | 28 Days |
|
|
|
| 1 |
| 624 |
| 586 |
| 624 |
| EG001 | Needle-Syringe | Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe. AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. Needle-Syringe | 2 | 623 | 516 | 623 |
|
| Peritonitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment | The SAE reported was unrelated to subject's participation in the study. |
|
| Viral Meningitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment | The SAE reported was unrelated to the subject's participation in the study. |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA (14.0) | Systematic Assessment | The SAE reported was unrelated to the subject's participation in the study. |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (14.0) | Systematic Assessment | The SAE reported was unrelated to the subject's participation in the study. |
|
| Arterial Injury | Cardiac disorders | MedDRA (14.0) | Systematic Assessment | The SAE reported was unrelated to the subject's participation in the study. |
|
|
| Tenderness | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local Adverse Reaction within 6 days of vaccination and Grade of >=1 |
|
| Itching | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local Adverse Reaction occurring within 6 days of vaccination and a Grade of >=1 |
|
| Redness | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local event occurring within 6 days of vaccination and Grade of >=1 |
|
| Swelling | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local Adverse Reaction occurring within 6 days of vaccination with Grade level >=1 |
|
| Bruising | General disorders | MedDRA (14.0) | Non-systematic Assessment | Local Adverse Reaction occurring within 6 days of vaccination with Grade level of >=1 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Malaise | Immune system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Chills | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Itching |
|
| Redness |
|
| Swelling |
|
| Bruising |
|
| Itching |
|
| Redness |
|
| Swelling |
|
| Bruising |
|
| Headache |
|
| Malaise |
|
| Myalgia |
|
| Chills |
|
| Nausea |
|
| Vomiting |
|