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The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.
The Advisory Committee on Immunization Practices (ACIP) recommends that all people aged 6 months and older be immunized to prevent influenza. Currently the only approved influenza vaccine across the entire age group is inactivated influenza vaccine (IIV). A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Additional safety and, ultimately efficacy, data is needed to support use in adults ≥50 years of age, an important age group as adults ≥65 years of age are among those at increased risk of influenza complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flublok | Active Comparator | Flublok containing 3x45µg (135µg total) of recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL |
|
| Afluria | Placebo Comparator | Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flublok | Biological | A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Common Hypersensitivity Reactions as Measure of Safety | Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration | Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration | 30 Days |
| Number of Participants With Local and Systemic Events Reported as a Measure of Safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Essink, MD | Meridian Clinical Research | Principal Investigator |
| Paul Bradley, MD | Meridian Clinical Research | Principal Investigator |
| William Seger, MD | Benchmark Research | Principal Investigator |
| Darrell Herrington, DO | Benchmark Research | Principal Investigator |
| George Bauer, MD | Benchmark Research | Principal Investigator |
| Frank Eder, MD | Regional Clinical Research | Principal Investigator |
| Treva Tyson, MD | Wake Research | Principal Investigator |
| Bob Weiss, MD | Maine Research Associates, LLC | Principal Investigator |
| Jeffrey Rosen, MD | Clinical Research of South Florida | Principal Investigator |
| Joe Blumenau, MD | Research Across America |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genova Clinical Research | Tucson | Arizona | 85704-1152 | United States | ||
| Clinical Research of South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26529070 | Derived | Izikson R, Leffell DJ, Bock SA, Patriarca PA, Post P, Dunkle LM, Cox MM. Randomized comparison of the safety of Flublok((R)) versus licensed inactivated influenza vaccine in healthy, medically stable adults >/= 50 years of age. Vaccine. 2015 Nov 27;33(48):6622-8. doi: 10.1016/j.vaccine.2015.10.097. Epub 2015 Nov 1. |
| Label | URL |
|---|---|
| Related Info | View source |
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Subjects were recruited at outpatient medical clinics over a period of five weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flublok | Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Afluria | Biological | Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs. |
|
Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration. |
| 7 Days |
| Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety | Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration | 7 Days |
| Principal Investigator |
| Steven Folkerth, MD | Clinical Research Center of Nevada, LLC | Principal Investigator |
| Leah Schmidt, DO | Genova Clinical Research | Principal Investigator |
| Eric Sheldon | Miami Research Associates | Principal Investigator |
| Alan C. Wine, MD | Rapid Medical Research, Inc. | Principal Investigator |
| Terry Poling, MD | Heartland Research Associates, LLC | Principal Investigator |
| Coral Gables |
| Florida |
| 33134 |
| United States |
| Meridian Clinical Research | Savannah | Georgia | 31406 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Benchmark Research | Metairie | Louisiana | 70006 | United States |
| Maine Research Associates, LLC | Auburn | Maine | 04210 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68164 | United States |
| Clinical Research Center of Nevada, LLC | Las Vegas | Nevada | 89104 | United States |
| Regional Clinical Research | Binghamton | New York | 13901 | United States |
| Wake Research | Raleigh | North Carolina | 27612 | United States |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |
| Benchmark Research | San Angelo | Texas | 76904 | United States |
| FG001 |
| Afluria |
Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs. |
| COMPLETED |
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| NOT COMPLETED |
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The primary analysis population includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Flublok | Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions. |
| BG001 | Afluria | Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs. |
| 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, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Number of Participants With Common Hypersensitivity Reactions as Measure of Safety | Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration. | The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized. | Posted | Number | participants | 30 Days |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration | Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration | The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized. | Posted | Number | participants | 30 Days |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Local and Systemic Events Reported as a Measure of Safety | Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration. | The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized. | Posted | Number | participants | 7 Days |
| |||||||||||||||||||||||||||||||
| Secondary | Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety | Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration | The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized. | Posted | Number | participants | 7 Days |
|
30 days following vaccine administration
Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flublok | Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions. | 5 | 1,314 | 20 | 1,314 | ||
| EG001 | Afluria | Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs. | 10 | 1,313 | 16 | 1,313 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebellar Stroke Syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Alcoholic Hepatitis | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leg Fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Salivary Gland Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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Rash, urticaria, swelling and edema were self-reported by subjects and most were not observed by investigators. Review by independent experts indicated that 42 of 52 subject-reported events did not represent Type 1 (IgE-mediated) hypersensitivity.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa M. Dunkle, M.D., Chief Medical Officer | Protein Sciences Corporation | 203-599-6064 | 153 | ldunkle@proteinsciences.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C528512 | FluBlok |
| C000613428 | Afluria |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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