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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose Influenza Vaccine | Experimental |
| |
| Standard Trivalent Influenza Vaccine | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Trivalent Influenza Vaccine | Biological | Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient. |
| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old. | Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28. | Baseline and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. | Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination. | 28 days |
| The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. |
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Inclusion Criteria:
18 years old to less than 65 years old
Subjects with malignancy must be receiving chemotherapy
Medically stable
Able to understand and willingness to sign a written informed consent
Able to comply with study procedures
Life expectancy of more than 3 months
Adequate organ function:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad Jamshed, MD | Rochester General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester General Hospital | Rochester | New York | 14621 | United States | ||
| Lipson Cancer Center Linden Oaks Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26721330 | Derived | Jamshed S, Walsh EE, Dimitroff LJ, Santelli JS, Falsey AR. Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: A pilot randomized clinical trial. Vaccine. 2016 Jan 27;34(5):630-635. doi: 10.1016/j.vaccine.2015.12.037. Epub 2015 Dec 22. |
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105 patients were enrolled but only 100 had evaluable data. 4 patients received a vaccination both in years 1 and 2 of the study- only year 1 results were included in the analysis. 1 additional patient was excluded from the efficacy analysis when it was revealed he had received a second vaccination in the same season.
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Dose Influenza Vaccine | High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| High-Dose Influenza Vaccine | Biological | Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient. |
|
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Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination. |
| Baseline and 28 days |
| Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines. | Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine | 7 days |
| Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines. | Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine | 7 days |
| Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines. | Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine | 28 days |
| Rochester |
| New York |
| 14625 |
| United States |
| Standard Trivalent Influenza Vaccine |
Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Dose Influenza Vaccine | High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient. |
| BG001 | Standard Trivalent Influenza Vaccine | Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old. | Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28. | Posted | Geometric Mean | 95% Confidence Interval | titers | Baseline and 28 days |
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| Secondary | The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. | Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination. | Posted | Number | percentage of participants | 28 days |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. | Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination. | Posted | Number | percentage of participants | Baseline and 28 days |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines. | Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine | Posted | Number | participants | 7 days |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines. | Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine | Posted | Number | participants | 7 days |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines. | Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine | Posted | Number | participants | 28 days |
|
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28 +/- 7 days post-vaccination
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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 | High-Dose Influenza Vaccine | High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient. | 0 | 50 | 26 | 50 | ||
| EG001 | Standard Trivalent Influenza Vaccine | Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient. | 0 | 50 | 22 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | NCIC CTG v4.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection-site pain | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection-site swelling | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection-site itching | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Fever | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injection-site redness | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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All research data and results generated during the course of or as a result of the Research Project shall be the property of Investigator and/or institution. Sanofi Pasteur will have access to the full set of data collected during the Research Project. The text of any manuscript, abstract or oral presentation based on this Research Project will be provided to Sanofi Pasteur at least 30 days prior to submission to a journal, a congress, or prior to an oral presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saad Jamshed, MD | Rochester General Hospital | 585-922-4020 | Saad.Jamshed@rochesterregional.org |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| 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 |
|---|---|
| D007252 | Influenza Vaccines |
| C000618615 | Fluzone High-Dose |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Male |
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| Pre Vaccination B Antigen |
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| Post Vaccination H1N1 Antigen |
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| Post Vaccination H3N2 Antigen |
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| Post Vaccination B Antigen |
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