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| ID | Type | Description | Link |
|---|---|---|---|
| 100980 | Other Identifier | IRB number | |
| 100980 | Other Identifier | IRB number, no grant for this study |
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Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be significantly different from adult stem cell transplant recipients receiving standard dose (SD) TIV.
Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody titers to influenza antigens compared to those who receive standard dose trivalent influenza vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | Active Comparator | Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine |
|
| Standard dose Trivalent Inactivated Flu Vaccine | Active Comparator | Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) | Biological | 0.5 ml of HD-TIV on visit 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients | Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level. | Day of TIV to 7 days after TIV |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses | Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natasha Halasa, M.D., M.P.H. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center, Clinical Trials Information Program | Nashville | Tennessee | 37232 | United States |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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Forty-seven patients consented to participate in this study, three were determined ineligible.
This phase X, double-blind study was conducted from September 2011 - April 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Dose Trivalent Inactivated Influenza Vaccine | Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard Dose Trivalent Inactivated Flu Vaccine | Biological | Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1. |
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| Before TIV and 28-42 days after TIV |
| Standard Dose Trivalent Inactivated Flu Vaccine |
Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine. Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Dose Trivalent Inactivated Influenza Vaccine | Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1 |
| BG001 | Standard Dose Trivalent Inactivated Flu Vaccine | Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine. Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1. |
| 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 | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| 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 | Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients | Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level. | Patients who received either the high-dose TIV or the standard dose TIV | Posted | Number | participants | Day of TIV to 7 days after TIV |
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| Secondary | Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses | Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus | Patients who received either the high-dose or the standard dose TIV and who had blood drawn for HAI titers before TIV and at 28-42 days after TIV. Data not available for 5 HD and 1 SD patients. | Posted | Number | participants | Before TIV and 28-42 days after TIV |
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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 Trivalent Inactivated Influenza Vaccine | Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1 | 11 | 29 | 5 | 29 | ||
| EG001 | Standard Dose Trivalent Inactivated Flu Vaccine | Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine. Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1. | 7 | 15 | 5 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fever | General disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
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| febrile neutropenia | Blood and lymphatic system disorders |
| |||
| chest pain, cardiac | Cardiac disorders |
| |||
| heart failure | Cardiac disorders |
| |||
| palpitations | Cardiac disorders |
| |||
| pericardial effusion | Cardiac disorders |
| |||
| Supraventricular tachycardia | Cardiac disorders |
| |||
| abdominal pain | Gastrointestinal disorders |
| |||
| diarrhea | Gastrointestinal disorders |
| |||
| nausea | Gastrointestinal disorders |
| |||
| vomiting | Gastrointestinal disorders |
| |||
| malaise | General disorders |
| |||
| Cholecystitis | Hepatobiliary disorders |
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| Infections and infestations other | Infections and infestations |
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| Laryngitis | Infections and infestations |
| |||
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Alkaline phosphatase increased | Investigations |
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| Creatinine increased | Investigations |
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| Platelet count decreased | Investigations |
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| weight loss | Investigations |
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| dehydration | Metabolism and nutrition disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
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| Hyperkalemia | Metabolism and nutrition disorders |
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| Hypoalbuminemia | Metabolism and nutrition disorders |
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| Hypomagnesemia | Metabolism and nutrition disorders |
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| Planned knee replacement surgery | Musculoskeletal and connective tissue disorders |
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| Chronic inflammatory demyelinating polyneuropathy | Nervous system disorders |
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| Presyncope | Nervous system disorders |
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| Transient ischemic attacks | Nervous system disorders |
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| Acute kidney injury | Renal and urinary disorders |
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| cough | Respiratory, thoracic and mediastinal disorders |
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| dyspnea | Respiratory, thoracic and mediastinal disorders |
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| hypoxia | Respiratory, thoracic and mediastinal disorders |
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| pleural effusion | Respiratory, thoracic and mediastinal disorders |
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| respiratory failure | Respiratory, thoracic and mediastinal disorders |
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| bonchitis obliterans | Respiratory, thoracic and mediastinal disorders |
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| Erythema multiforme | Skin and subcutaneous tissue disorders |
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| Methicillin-resistant Staphylococcus aureus bacteremia | Infections and infestations |
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| rectal abscess | Gastrointestinal disorders |
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| diffuse muscle pain | Musculoskeletal and connective tissue disorders |
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| wheezing | Respiratory, thoracic and mediastinal disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders |
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| investigations, other | Investigations |
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| anorexia | Gastrointestinal disorders |
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| cough | Respiratory, thoracic and mediastinal disorders |
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| dry skin | Skin and subcutaneous tissue disorders |
| |||
| edema limbs | General disorders |
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| hepatobiliary disorders, other | Hepatobiliary disorders |
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| hypokalemia | Metabolism and nutrition disorders |
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| mucositits oral | Gastrointestinal disorders |
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| nasal congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| skin and other subcutaneous disorders-other | Skin and subcutaneous tissue disorders |
| |||
| vomiting | Gastrointestinal disorders |
| |||
| wheezing | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natasha Halasa, Associate Professor of Pediatrics | Vanderbilt University | 615-322-3346 | natasha.halasa@vanderbilt.edu |
| >=65 years |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
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