Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Syneos Health | OTHER |
| Department of Health and Human Services | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.
As the spectrum of influenza vaccines rapidly evolves to quadrivalent formulations with the intention of offering broader protection to include both lineages of influenza B strains, it is appropriate to transition Flublok from a trivalent to a quadrivalent formulation. The demonstration of non-inferior post-vaccination Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) to antigens in the Flublok Quadrivalent formulation compared to those of the matching antigens in a US - approved IIV4 is intended to support licensure of Flublok Quadrivalent for the adult population for which Flublok trivalent is currently approved. The comparison of safety and reactogenicity of Flublok Quadrivalent to that of IIV4 is expected to confirm a similar safety profile.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flublok Quadrivalent Influenza Vaccine | Experimental | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL |
|
| Inactivated Influenza Vaccine (IIV4) | Active Comparator | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flublok Quadrivalent | Biological | Intramuscular injection of study vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination. | Day 28 after final vaccination |
| Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated. | Day 0 and Day 28 after final vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Systemic and Injection Site Reactogenicity | Days 0-7 | |
| Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) | Six months post-vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William Seger, MD | Benchmark Research, Fort Worth, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benchmark Research - Sacramento | Sacramento | California | 95816 | United States | ||
| Clinical Research of South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28968871 | Derived | Dunkle LM, Izikson R, Patriarca PA, Goldenthal KL, Muse D, Cox MMJ. Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age. J Infect Dis. 2017 Dec 5;216(10):1219-1226. doi: 10.1093/infdis/jix478. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Flublok Quadrivalent Influenza Vaccine | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent: Intramuscular injection of study vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Inactivated Influenza Vaccine (IIV4) | Biological | Intramuscular injection of study vaccine |
|
| 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 |
| Meridian Research | Bellevue | Nebraska | 68005 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68164 | United States |
| Meridian Research | Dakota Dunes | South Dakota | 57049 | United States |
| Benchmark Reseach | Austin | Texas | 78705 | United States |
| Benchmark Research - Fort Worth | Fort Worth | Texas | 76135 | United States |
| FG001 | Inactivated Influenza Vaccine (IIV4) | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine |
| COMPLETED |
|
| NOT COMPLETED |
|
The baseline analysis population includes the Safety Population, all randomized subjects who were immunized and provided any safety data (solicited or unsolicited) following administration of study vaccine.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Flublok Quadrivalent Influenza Vaccine | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent: Intramuscular injection of study vaccine |
| BG001 | Inactivated Influenza Vaccine (IIV4) | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study 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, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | 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 | Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination. | The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 after final vaccination |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Systemic and Injection Site Reactogenicity | The Reactogenicity Population includes subjects who recorded any systemic reaction data and injection site reaction data following administration of study vaccine. This was two subjects less than the Safety Population. | Posted | Number | participants | Days 0-7 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) | The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine. | Posted | Number | participants | Six months post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated. | The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 0 and Day 28 after final vaccination |
|
All AEs collected 28 days after study immunization and all Serious Adverse Events (SAEs) collected through six (6) months after study immunization.
The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.
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 | Flublok Quadrivalent Influenza Vaccine | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent: Intramuscular injection of study vaccine | 10 | 998 | 63 | 998 | ||
| EG001 | Inactivated Influenza Vaccine (IIV4) | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine | 2 | 332 | 24 | 332 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Periumbilical abcess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arm amputation | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasophayngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| B/Massachusetts |
|
| B/Brisbane |
|
|
|
|
|